Patent Application
20050182658
The present invention is generally related to the field of clinical studies.
The framework for traditional business models for clinical studies has been rather stable over the last few decades. In such a business model, a sponsor (such as a pharmaceutical company which has developed a new drug, for example) paid all participants which performed in the study. At a minimum, these included participating patients and a medical doctor (an investigator) in charge of supervising the patients. In many cases, an investigation or clinical trial site (e.g., a hospital) was additionally included, where one or more investigators was employed.
So called contract research organizations (CROs) further established their services in the workflow chain of clinical studies, in between the sponsor on one end, and the investigator and patients on the other. The CRO often took over the complete management of the clinical study, including all necessary services including, for example, development of study protocol, recruiting patients and investigators and/or investigation sites, contracting the participants, supervising the conductance of the study, collecting and evaluating data, channeling the payment from the sponsor to the participants, etc. Of course, for such services, the CRO received a substantial part of the aforementioned payment for their own services.
When recruiting the patients, the CRO, or even the sponsor, tended to use and still uses crude methods wherein prospective patients fill out forms and are screened as candidates for clinical studies. The data utilized is normally that obtained from the patient himself or herself. Regarding the investigator or investigator/clinical trial site chosen to conduct/monitor/etc. the study, information previously obtained by the sponsor or CRO can be used. However, this is often a slow process which often does not produce an ideal patient, investigator or investigator/clinical trial site.
This traditional cash flow model had some flaws. For example, it did not foresee making payments dependant on the quality of delivered performances. This was mainly because it was very difficult to impossible in the past to measure the quality of performance. Therefore it was neither possible for the sponsor to save money by paying less for a performance which was more inferior than expected; nor was it possible to reward excellent performance through additional incentives.
The present inventors have recognized problems with the traditional clinical study model, and an object of the present application is to improve on the traditional clinical study model, and thus improve the clinical study or clinical study process. One specific object involves improving cost-effectiveness of a clinical study. In one embodiment, this can include, for example, the use of clinical IT infrastructure to derive, when correlated with obtained criteria of a clinical study, performance measures for improving the clinical study. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter. The present inventors have recognized these and other needs for improving a clinical study.
Further, the inventors have recognized that in the traditional setting of a clinical study, the CROs had no access to this IT infrastructure. The investigation or clinical trial sites such as a hospital, for example, were the owner of such IT infrastructure and databases. As such, the sponsors and CROs had no such access. However, as these investigation/clinical trial sites were biased parties and thus sponsors of clinical studies and CROs were not interested in their involvement to the extent of using their IT infrastructure.
The present inventors, in one embodiment of the present invention, have recognized that further value of such clinical IT databases can be obtained when clinical data from a plurality of different investigation sites is used, especially different investigation sites participating in the same clinical study. This added value can be provided by an independent party, a Hospital IT Solution provider (HISP) who can develop, sell, install and maintain clinical IT solutions and databases, and in many cases can also store and maintain related databases obtained from a correlation of the traditional clinical IT databases and clinical study criteria.
The present inventors, in one embodiment of the present invention, also recognized the importance of the introduction of some type of quality control and benchmarking measures. By inclusion of various measures, the payment for the clinical study can be made to be performance/outcome oriented, rather than oriented as contracts for upfront fixed amounts.
An embodiment of the present application is directed to a method of improving a clinical study. The method may include obtaining criteria for the clinical study; comparing the clinical data with the obtained criteria using a computer device; and deriving, using the computer device, performance measures for improving the clinical study. These performance measures may be used for ranking, and consequently improving, the clinical study. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
In another embodiment, a method of improving a clinical study may include creating first electronic database of criteria for the clinical study and creating a second electronic database with rules for calculating performance measures from the criteria and from clinical data. The first and second databases and the clinical data may then be evaluated to calculate performance measures. The performance measures may then be stored in a third database and, from the third database, a ranking of the performance measures may be derived for use in improving the clinical study. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are calculated for at least one performance parameter.
In another embodiment of the present application, a method may include creating an electronic database of rules for calculating performance measures from criteria of a clinical study and from clinical data. The performance measures may then be calculated from the database of rules, the criteria of the clinical study and the clinical data. Finally, from the performance measures, a ranking of the performance parameter measures may be derived. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are calculated for at least one performance parameter.
Other embodiments of the present application may include devices for implementing any of the aforementioned methods, programs adapted to perform any of the aforementioned methods when executed on a computer, and/or computer readable mediums storing any of the aforementioned programs.
Additional embodiments of the present application may include apparatuses for improving a clinical study. One such apparatus, in one embodiment, may include a first electronic database including criteria for the clinical study; a second electronic database including rules for calculating performance measures from the criteria and from clinical data; a rules engine, adapted to interface with and evaluate the first and second databases and the clinical data to calculate the performance measures. Finally, a third database may then be included for storing the calculated performance measures. A ranking of the performance measures may then be derivable from the third database for use in improving the clinical study. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are calculated for at least one performance parameter.
For a full understanding of the nature and advantages of the various aspects of the invention, reference should be made to the detailed description of exemplary embodiments taken in conjunction with the accompany drawings. The detailed description provides only exemplary embodiments of the invention and thus, the claims of the present invention should not be limited as such.
The present invention will become more fully understood from the detailed description of preferred exemplary embodiments given hereinbelow and the accompanying drawings, which are given by way of illustration only and are thus not limitive of the present invention, and wherein:
In one embodiment, the present invention is directed to a method of improving clinical study, more specifically improving a business model of a clinical study utilizing clinical information technology (IT) infrastructure and then creating additional databases. In one embodiment, the method includes obtaining criteria for a clinical study, wherein the study can include a clinical study protocol, target performance parameters of the clinical study, etc. The obtained criteria and clinical data (obtained from existing clinical IT infrastructure, for example) are then compared using a computer device (a device including a processor for example). From the compared information, performance measures can then be derived. These derived performance measures can then be used for improving the clinical study (by ranking, for example). Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
Clinical data can include data stored in a database of existing clinical IT infrastructure, such as an electronic healthcare database, for example. This can include, but is not limited to at least one of a database with electronic patient records, a database of clinical workflow management system, information from a hospital IT system (financial or clinical), information from a laboratory or radiology information system, information from a picture archiving and communication system (PACS), information from a physician's IT system, for example, etc.
In one aspect of one embodiment, information or contracts which regulate the amounts of payment upfront, between the sponsor on one side and the CRO, and/or investigator, and/or patient on the other side, may be based on organizational milestones. In the past, the clinical trial business models did not make use of clinical IT infrastructure and databases, such as electronic patient records (EPR), hospital information systems (HIS) or clinical workflow management systems. In an embodiment of the present application, such clinical IT infrastructure and databases, storing various types of clinical data, are utilized in connection with obtained criteria for the clinical study, to derive performance measures of the study, which can then be used to improve the study (and/or the clinical study business process). Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
As shown in
Often, such Hospital IT solutions include also the service to store and backup the huge amount of clinical data at HISP-owned mass data storage devices. Typically, the solution business also includes building a model of the customers individual clinical processes, describing this model with a computer based workflow language, and uploading this electronic workflow model into the rules engine of the clinical workflow IT.
Due to this highly interactive role of the HISP 200 in this solution provider business model, the HISP 200 often has both physical access to a considerable part of electronic clinical data, a deep understanding of his customer's clinical process, and access to the electronic model and rules engine of the clinical process. As a consequence of the electronic modeling of the clinical workflow, performance data on the workflow can be derived in an automated electronic way, and retrieved from the IT system. Since a clinical study is a special case within the general clinical workflow, it is within the scope and competence of the HISP 200 to make use of the clinical IT infrastructure described above to improve also the clinical study process.
Through his ability to access the Hospital IT (infrastructure and databases), the HISP 200 is able to analyze clinical data, such as that stored in any of the clinical workflow management system 210, EPR 212, HIS 214 (or any other type of clinical IT infrastructure and/or database). This HISP 200 connects or is otherwise networked to, and can thereby access/receive and then analyze data from any of the clinical workflow management system 210, EPR 212, HIS 214 (or any other type of clinical IT infrastructure and/or database). The HISP 200 may further be networked or otherwise connected to the sponsor 220 and/or the CRO 230. The HISP 200 then receive or otherwise obtain criteria for a clinical study from the sponsor 220 and/or CRO 230 and can then compare the obtained clinical data to (analyze in conjunction with or based upon) the obtained criteria for a clinical study. The HISP 200 of an embodiment of the present application is then able to derive performance measures for improving the clinical study from the compared information. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
As shown in
The payment to the HISP 200 may be for achieving advantages such as reduced time or cost savings or other performance parameter aspects, wherein the HISP may be involved in calculating potential advantages obtained from certain clinical trial sites/patients/investigators/etc. determined to exceed target performance parameter measures or other aspects of the obtained criteria. Clinical data of a plurality of clinical trial or investigation sites/patients/investigators/etc., and the obtained criteria, may be further analyzed or compared to determine clinical trial or investigation sites which meet or exceed target performance parameter measures of the obtained criteria and such plural patients/clinical trial sites/investigators/etc may be ranked accordingly. This ranked information can then be output or otherwise sent to the sponsor 220 and/or CRO 230 for use in determining desired patients/clinical trial sites/investigators/etc. for use in the study and the HISP 200 can then be paid or contracted for some portion of savings projected and/or achieved. Finally, the CRO 230 may be involved in paying a portion of the money to the investigators 240, the patients 250 and/or to the investigation sites not shown. Alternatively, if the CRO 230 is not involved, the HISP 200 may be involved in making such payments.
Throughout various embodiments of the present application, reference is made to “performance parameters”. With regard to such performance parameters, these can include but are not limited to study duration, costs, study result reliability, and any other “measurable” form of value to a sponsor 220 regarding the clinical study (thus resulting in performance parameter measures, namely some “measure” of a performance parameter). Such performance parameters are very important to a clinical study and can thus result in a huge savings to the sponsor, a portion of which can thus be passed on to the HISP 200. For example, the faster the clinical study can be performed (the shorter the duration), the sooner a product (such as a drug, for example) can go to market. Each day on the market can lead to thousands and even millions of dollars. Further, if costs of the clinical study can be reduced, savings are achieved. Regarding study reliability, the more reliability can be improved, the more valuable the clinical study is and the potentially faster the drug, for example, can go to market. In addition, if poor study reliability can be detected early in a clinical trial, the study at a particular trial site for example, can be terminated quickly, again resulting in an overall savings to the sponsor 220. Such performance parameter measures can be derived and/or calculated based upon clinical study criteria which may include target performance parameter measures.
Other non-limiting examples of “performance parameters” can include, but are not limited to:
“Criteria”, as referenced throughout the embodiments of the application, refers to clinical study criteria. These “criteria” are important aspects of the clinical study. These criteria of the study can be used by the HISP 200 to formulate desired performance parameters and then, using existing clinical data, projected performance parameter measures can be calculated for one or more patients/investigators/clinical trial sites/etc. Thus, the criteria outline key or other important aspects of the study which, when provided and correlated with clinical data, can help produce likely performance parameter measures that have an effect or importance regarding an outcome of the study (effect on time to perform the study, cost of the study, etc.).
Some non-limiting examples of “criteria”, which may influence or help to determine performance parameters/performance parameter measures or other clinical study measures positively may include, but are not limited to:
Often, elements relating to this “criteria” cannot be measured directly, but must be deduced from other measurable parameters or clinical data, and perhaps from a combination of other measurable parameters or other measurable clinical data. Thus, the HISP 200 can, for example, build an empirical database for use in such situations. As one example, such a database can be built based on, for example, typical “dropout” rates of patients (i.e. percentage of patients who discontinue participation in the study before the scheduled termination of the study), wherein these rates might vary with investigation sites, patient age, geography, etc. Thus, the HISP 200 can create a type of mathematical formula or weighting factors regarding the combining of several direct and indirect aspects of the criteria into a prediction of probable benefit, such as probable financial benefit. Most likely, this formula will include a weighted sum or weighted product of several single criteria. This can then be correlated with existing clinical data from the clinical IT infrastructure to derive performance measures or performance parameter measures if the criteria includes performance parameters. Thereafter, an output ranking may be derived from the calculated/derived performance measures, the ranking being based upon weighted determinations using the weighing factors. The ranking can be for any or all of the parameters, and can be for any of single or multiple patients/clinical trial sites/investigators/etc.
As a result, information is available as to which clinical trial site, investigator or patient group performed best in an actual and/or recent clinical study. Performance may be measured as overall performance, averaging across a combination of several criteria for example; as a performance with respect to a specific criterion, etc.
It should be further noted that a level of guarantee of performance for at least one of a plurality of clinical trial sites, for a clinical trial for example, may be provided based on calculated performance measures. A plurality of varying levels of guarantee may be provided for a plurality of clinical trial sites. These levels of guarantees may be based, for example, upon weighted determinations, wherein weighting factors may include one of time for performing a clinical trial, quality, geographic location, etc., factors important to the sponsor 220/CRO 230 in obtaining fast and accurate results for the study.
The assignee of the present application has further been involved in various other inventions regarding clinical studies, and in some cases the use of clinical IT infrastructure, in order to improve the development of clinical study business models and/or the development of clinical study protocols; improving the effectiveness of patient recruiting; controlling the compliance of clinical study protocol rules; etc. The entire contents of each of the following applications is hereby incorporated by reference in the present application:
Thus, as such, the HISP 200 acts as an additional service party in the workflow chain and adds value in the chain of a clinical study utilizing clinical IT infrastructure and databases such as EPR 212, HIS 214, clinical workflow management system 210, etc. in an advantageous way. As such, payment and cashflow for a clinical study may be performance and outcome dependent.
In one embodiment of the present invention, further value of such clinical IT databases has been realized, wherein clinical data from a plurality of different investigation sites is used, especially different investigation sites participating in the same clinical study. This information adds to the value that can be provided by HISP 200 in
Thus, it should be understood that
Stated another way, the method may include further deriving/producing/outputting, from the derived performance measures/performance parameter measures, a ranking of the performance measures/performance parameter measures. The ranking may be for at least one of clinical trial sites, payment amounts and/or other things, such as study discontinuation decisions, suitability of patients for the clinical study, etc. for example. The names of clinical trial sites, determined from the rankings, can then be output to a sponsor who can then make a decision as to which patients are best suited to a study, which clinical investigation or trial sites are best suited to conduct a particular clinical study, etc.
Thus, from performance measures/performance parameter measures, a ranking of the performance measures/performance parameter measures can be derived. The ranking can include suitability of patients for the clinical study, as mentioned above. The phrase “suitability of patients for this clinical study” can be defined as follows.
The clinical study protocol also may contain a subset of criteria which define suitability of patients. This can include for example, but is not limited to: suitable patients being those which, for example, have been diagnosed for a certain disease at least 2 years and no more than 5 years ago; are between the ages of 40 and 60; patients within a distance not exceeding 20 miles from the clinical trial site. Using suitable weighting factors, from criteria, a “suitability score”, ranging e.g. from 0 . . . 100%, can be calculated. For example, a patient of age 50, living 2 miles from the clinical trial site and having been diagnosed 3 years ago, has a ranking of 100%; whereas a patient living 30 miles away, having been diagnosed 5 years ago, and being of age 60 receives a 30% suitability score ranking.
Such rankings/results provide potential savings to the sponsor 220, which can be calculated/estimated from the derived performance measures, and a portion of this potential savings can then be paid/contracted to the HISP 200. The potential savings can be calculated from using the clinical trial sites determined to exceed target performance parameter measures of the obtained criteria. Thereafter, the HISP can be paid and/or contracted for performance of the clinical study based upon the calculated potential savings. The potential savings can include any type of potential advantages, for example, at least one of reduced time and cost savings.
Thus, the HISP 200 can act, based upon calculated potential advantages or potential savings, including at least one of reduced time and cost savings, for example, as an entity who can be contracted on a risk-sharing basis. The HISP 200 can be contracted for performance of the clinical study based upon the calculated potential savings on a risk-sharing basis, based upon at least one of the potential advantages. As such, payment can be contracted or based upon the calculated potential savings, with the payment being based upon a percentage of the achieved savings. This payment/contacting can be made directly from/with the sponsor 220, or from/with the CRO 230, for example.
As previously stated, the HISP 200 can have direct access to the clinical data from one or a plurality of clinical studies, from one or a plurality of investigation clinical trial sites, including access to information in at least one electronic healthcare databases such as a clinical workflow management system 210; EPR 212; and/or HIS 214. However, indirect access to this data can also be provided through the HISP 200, wherein the HISP 200 can then perform an analysis of the clinical data using the obtained criteria for the clinical study (performing a comparison of data and criteria for example), to derive performance measures/performance parameter measures for improving the clinical study. The information regarding the specifics of the clinical study can come from the sponsor 220 or from the CRO 230.
An advantage that the HISP 200 can offer, is access to clinical data such as patient data, clinical workflow data, etc., much earlier than the CRO 230, who receives only bundled data in the form, typically, of milestone reports. A HISP 200 has access to the relevant clinical data in real time, and can extract and update all information on study-relevant clinical data such as patient data, on a daily basis for example. To this end, the HISP 200 can also incorporate new software modules in a clinical workflow management system 210, new data entries in the EPR database 212, etc., in order to specifically collect information on a clinical study. With the use of such real-time data, a much more effective monitoring of the clinical study partners and the achievement of clinical study milestones is possible.
For services of achieving or calculating some potential savings, the HISP 200 may be reimbursed with a certain percentage from the total budget for a clinical study. The cost for a clinical study essentially depends on many factors, including but not limited to the duration of the study, the number of participating patients, etc. Additionally, the last day that it takes for the study to be performed, namely for the reduced time of the study or for each day saved, a particular drug on which this study is based may be on the market one day earlier. Thus, time saving for performing the clinical study is very important to the sponsor and has a tremendous impact on the turnover of the sponsor.
In a more defined business model, the HISP 200 may choose to offer services on a risk sharing basis in a number of ways, including but not limited to the following:
In an analogous way, the HISP 200 may contract on a risk-sharing basis for the service to accrue patients for a study. The HISP 200 may use the access to the critical IT infrastructure, including but not limited to the clinical workflow management system 210, the EPR 12, the HIS 214, etc. of one or a plurality of clinical study/investigation sites, to identify potential participants. The HISP 200 may then be reimbursed for the number of patients actually contracted, and/or for reducing the time taken to begin the study, as compared with a target value or other parameters for beginning the study as can be found in the study profile (contract) or other criteria obtained regarding the study. Overall, cost effectiveness of the clinical study can be improved by offering services which derive different types of benchmarking and performance criteria from criteria of the clinical study analyzed in conjunction with clinical IT infrastructure, such as information from hospital IT databases (which may taken from multiple investigation/clinical trial sites). Payments can be made the clinical study participants and to the HISP 200 itself within this criteria. Optionally, the HISP 200 can make its own payments pending on the outcome of the study and the risk-shared model.
In an embodiment of the application, the method of improving the clinical study, includes creating a first electronic database of criteria for the clinical study and creating a second electronic database of rules for calculating performance measures from the criteria and clinical data. Thereafter, the first and second databases and the clinical data is evaluated to calculate the performance measures. The performance measures are then stored in a third database and from the third database, a ranking of the performance measures is derived for use in improving the clinical study. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
In one embodiment, a first electronic database is built by the HISP 200. This database is built from criteria for the clinical study (rules, values, thresholds, etc.) either automatically or manually, extracting this information from a clinical study protocol for example. This clinical study protocol can be provided directly from the sponsor 220 or can be provided from the CRO 230 based upon the defined clinical study requirements provided by the sponsor 220.
A second electronic database may then created by the HISP 200 with rules on how to calculate performance measures from the criteria and from clinical data. Again, the clinical data can be obtained from an electronic healthcare database, such as a clinical workflow management system 210, an EPR 212 and/or the HIS 214, etc. The criteria can include various target performance parameter measures, wherein clinical data of a plurality of clinical trial sites and the obtained criteria for the clinical study may be further analyzed to determine clinical trial sites which may exceed target performance parameter measures of the obtained criteria. From various performance parameter measures, a ranking of the performance parameter measures can be derived wherein the ranking may be for at least one of clinical trial sites, payment amounts, study discontinuation decisions (namely, decisions as to whether or not a clinical study should be discontinued), and suitability of patients for the clinical study, etc.
Thereafter, once the first and second databases are created, a rules engine can be developed or built, which interfaces to the first and second electronic databases and to the clinical databases such as the workflow management system 210, the EPR 212 and the HIS 214, etc. This rules engine can act in evaluating the first and second databases to calculate the performance measures. The performance measures can be stored in a third database and/or output or imported. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived for at least one performance parameter.
Finally, from this third database, a ranking of the performance measures can be derived, or the third database can be evaluated, for use in improving the clinical study. For example, the third database (or the performance measures themselves, not stored in a formal database) can be evaluated to derive a ranking of clinical trial sites, payment amounts, study discontinuation decisions, suitability of patients for the clinical study, etc.
Thus, an apparatus for improving a clinical study can include a first electronic database including criteria for the clinical study and a second electronic database including rules for calculating performance measures from the criteria and from the clinical data. The apparatus can include a rules engine, adapted to interface and evaluate the first and second databases and the clinical data to calculate the performance measures. Finally, a third database can be included for storing the performance measures, wherein a ranking of the performance measures is derivable from the third database for use in improving the clinical study.
Again, in this embodiment, the criteria of the clinical study can be included in the clinical study protocol. The clinical data may be obtained from at least one electronic healthcare database including at least one of those previously set forth. The criteria can include at least one of rules, values and thresholds. Further, the criteria for the clinical study may include at least one performance parameter, wherein performance parameter measures are derived/calculated for at least one performance parameter. In addition, the rules engine may be further adapted to interface with at least one electronic healthcare database including the clinical data, to evaluate the databases and calculate the performance measures/performance parameter measures. Additionally, the ranking may be used for at least one of ranking clinical trial sites, ranking payment amounts, ranking to make study discontinuation decisions, suitability of patients for the clinical study, etc.
One example of risk-sharing business model for the HISP 200 in clinical studies is shown in
Measures for increased benefit can include, for example, overall cost of the study, duration of the study, reliability or accuracy of the resulting data from the study (i.e., statistical significance of derived conclusions), etc. Overall cost of the study is a direct financial measure, whereas indirect financial benefits from a reduced study duration may depend on the accordingly achieved shortening of market entry time and thus increased revenue achieved by the product (drug, etc.) which is the subject of the clinical study.
An even more indirect benefit may be an increased statistical significance of the conclusion of the study. The desired conclusion most often is “the new medication is suitable for and improves the treatment of disease x”. As one non-limiting example, this conclusion may be derived from trying the medication on four patients only, for example, the probability of the observed positive outcome is a “false positive”, i.e., the medicate seemed to help in four patients, but does not help in the next 100 patients, is much higher than if the medication was tried on 1,000 patients and helped in 950 cases. Therefore, a good statistical significance reduces the probability of market introduction of the drug was in vane (for example, at very high promotional costs), and the drug has to be removed from the market.
Referring back to
Thus, based upon the calculated performance parameter measures, the HISP 200 may contract to manage the clinical study. Further, a ranking may be derived from the calculated performance parameter measures, wherein the ranking is used for at least one of ranking clinical trial sites, ranking payment amounts, ranking to make study discontinuation decisions, suitability of patients for the clinical study, etc. The ranking of the performance parameter measures may be derived at predefined milestones during the clinical study for example, wherein the performance measures derived at each milestone may be compared with the threshold or threshold criteria and wherein the clinical study may be discontinued if threshold criteria are not met. Further, the contracting may include receiving a percentage of money, for example based upon the calculated performance parameter measures, a calculated potential savings, a percentage of money saved from the improvement, etc.
As shown in element 440, the HISP 200 may then suggest or recommend discontinuation of the clinical study if one or more of the target performance parameter measures, rules, values and/or threshold criteria is not met. This discontinuation of a clinical study at a particular clinical trial site, for example, may result in a large reduction in losses or costs which may have been incurred if the study had been continued and unfavorable results were achieved. Thus, this can be a large cost savings to the sponsor 220 and thus the HISP 200 may receive a contracted percentage of money not spent on a probably unsuccessful study, as shown in element 450.
Each of the various embodiments discussed above can include the use of weighting factors. For example, the clinical study criteria obtained can include weighing factors, wherein the weighting factors may reflect a likelihood of the “criteria” to correlate with direct benefit, such as financial benefit, for example. The deriving of the performance measures may e based upon one or more weighting factors. With regard to performance parameters such as study duration, costs, study result reliability, major “criteria” which may help to influence these measures positively may include, but are not limited to:
Often, these “criteria” cannot be measured directly, but must be deduced from other measurable parameters, and perhaps from a combination of other measurable parameters. Thus, the HISP 200 may, for example, build an empirical database on typical “dropout” rates of patients, wherein these rates might vary with investigation sites, patient's age, geography, etc. Thus, the HISP 200 can create a type of mathematical formula or weighting factors regarding the combining of several direct and indirect criteria into a prediction of probable benefit, such as probable financial benefit. Most likely, this formula will include a weighted sum or weighted product of the single criteria. Accordingly, an output ranking may be derived from the calculated performance parameter and a ranking may be based upon weighted determinations using the weighing factors.
Thus, from performance parameter measures, a ranking of the performance parameter measures can be derived. The ranking may be for at least one of clinical trial sites, payment amounts, study discontinuation decisions and suitability of patients for the clinical study.
It should be further noted that a level of guarantee of performance for at least one of a plurality of clinical trial sites, and/or for other clinical trials, may be provided based on calculated performance measures/performance parameter measures. A plurality of varying levels of guarantee may be provided for a plurality of clinical trial sites. This level of guarantee may be based upon weighted determinations, wherein weighting factors may include one of time for performing a clinical trial, quality and geographic location, etc.
Further, the performance parameter measures or performance measures can be used in the determination of whether or not the particular clinical study should be discontinued. For example, the derived performance parameter measures or performance measures can be compared to certain required thresholds (or target performance parameters obtained from the clinical study criteria), and a decision can be made in step 550 to discontinue a study if the performance threshold is not met.
The services of the HISP 200 may be contracted to obtain and manage a particular study, to derive the aforementioned ranking of clinical trial sites according to performance parameter measures or performance measures, to receive a contracted percentage of money not spent on a probable unsuccessful study, etc. Further, derived performance parameter measures or performance measures can be used to make payment, by a sponsor to a particular clinical trial site, patient, investigator, etc., based upon a performance parameter measure or parameter achieved as shown in element 560. The HISP 200 may then receive a percentage of money for deriving these particular performance parameter measures or performance measures.
As one non-limiting example of the methodology of one embodiment of the present application, a clinical study protocol (including clinical study criteria) may be for testing a new medication for hypertension. The target patient group may include patients between 20 and 50 years of age which have been diagnosed with hypertension for the first-time, and which have not been prescribed drugs for treating hypertension previously. This may be outlined in the clinical study criteria obtained/received by the HISP 200.
In such an exemplary embodiment, patients for the study may be divided into two groups of equal size, one group being given the new medication in the test and the other group being given conventional medication. As set forth in the criteria of the clinical study, the study first requires a whole body CT scan for each patient at the beginning of the study, excluding specific pathologies such as aortic malformations, etc. for the hypertension. Further information regarding the criteria of the clinical study may include an observation period for each patient for six months, wherein the development of blood pressure may be controlled weekly, for example. One thousand patients may be planned to be enrolled at three different clinical trial sites, for example. The cost for the study may be planned at “x” dollars and the targeted time frame for the study may be two years. The prognostic statistical significance for the study has been previously calculated to be 82%. Again, this information is preferably, in the example, part of the clinical study criteria obtained/received by the HISP 200.
In connection with an embodiment of the present application, the HISP 200 receives/obtains in some way, the criteria for a clinical study. The HISP 200 can then compare/correlate this criteria of the clinical study protocol with electronic healthcare database clinical IT databases of one or more clinical trial sites, regarding past performance of an investigator or investigation/clinical trial site. The HISP 200 can then evaluate, utilizing the criteria and clinical data, to identify the best performing investigators or investigation/clinical trial sites. For example, the HISP 200 can review the EPR 212 to identify how many suitable patients have been treated in this particular institution (clinical trial site or investigation site) over a period of time, e.g. the past two years. A research table of the clinical workflow management system 210 may further be analyzed to determine which of the institutions or clinical trial sites include the required whole body CT scanner. Further, the EPR 212 can be used to investigate which clinical trial site is experienced in that particular procedure by counting or reviewing the number of such exams previously done in the past, for example. The HISP 200 database of patient dropout rates for this patient group may then be analyzed.
From this analysis, the HISP 200 may conclude, for example, that the study duration is reducible by six months, the overall cost is reducible by 10% and at the same time the statistical significance of 89% is achievable, as the exemplary calculated performance parameter measures for example. These performance parameter measures can be determined for a single clinical trial site or can be ranked for a plurality of clinical trial sites, wherein different performance parameter measures can be calculated for each trial site, namely different values of performance parameter measures.
From this information, the HISP 200 can then propose these improvements to the sponsor 220 of the clinical study, with a condition of a contract to the top three, for example, most suitable investigators or clinical trial or investigation sites. Plus, for particular performance parameter measures calculated, a plurality of investigation/clinical trial sites may be ranked which can achieve the calculated or satisfactory performance parameter measures. The sponsor 220 in turn can calculate the possible financial benefit if these improvements are realized.
Although a formula for calculating the risk-shared payment may depend on the actually achieved stated improvements, this risk-shared payment may be negotiated and the HISP 200 contracted on this basis. During the study, the HISP 200 may then evaluate multiple clinical trial sites, partners, etc. by constantly re-evaluating study-relevant patient data and/or the EPR 212, for example, of enrolled patients; and by taking additional measures when actual performance is not as good as expected. Thus, the performance parameter measures can be recalculated based upon the monitored information for at least one clinical trial site, and/or a re-ranking determined. Further, a guaranteed level of performance can be provided for at least one of a plurality of clinical trial sites for the clinical trial based on the recalculated performance parameter measures and/or the re-ranking, based upon the monitored information.
Any of the aforementioned methods may be embodied in the form of a system or device, including, but not limited to, any of the structure for performing the methodology illustrated in the drawings.
Further, any of the aforementioned methods may be embodied in the form of a program. The program may be stored on a computer readable media and is adapted to perform any one of the aforementioned methods when run on a computer device (a device including a processor). Thus, the storage medium or computer readable medium, is adapted to store information and is adapted to interact with a data processing facility or computer device to perform the method of any of the above mentioned embodiments.
The storage medium may be a built-in medium installed inside a computer device main body or a removable medium arranged so that it can be separated from the computer device main body. Examples of the built-in medium include, but are not limited to, rewriteable involatile memories, such as ROMs and flash memories, and hard disks. Examples of the removable medium include, but are not limited to, optical storage media such as CD-ROMs and DVDs; magneto-optical storage media, such as MOs; magnetism storage media, such as floppy disks (trademark), cassette tapes, and removable hard disks; media with a built-in rewriteable involatile memory, such as memory cards; and media with a built-in ROM, such as ROM cassettes.
Exemplary embodiments being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the present invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.
The present application hereby claims priority under 35 U.S.C. §119 on U.S. provisional patent application No. 60/545,168 filed Feb. 18, 2004, the entire contents of which are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60545168 | Feb 2004 | US |
