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Case Studies
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Ideal Site Selection
Combining product suites and enhancing services was the right approach for ultimately achieving enrollment for a clinical study of a treatment for immune thrombocytopenic purpura. It enabled the sponsor to a.) identify the required attributes of the ideal investigative practice, b.) determine the optimal locations for sites in order to reach sufficient numbers of patients, and c.) identify a wealth of potential sites, from which the sponsor was able to select the best practices.
Study
- Phase III
- U.S.-based
- 170 patients
Objectives
- Identify and select a sufficient number of new sites to make up a severe enrollment shortfall.
Recruitment Challenges
- The low incidence of the condition
- High number of ITP studies competing for the same limited patient pool
Toolkit
| SiteOPTIMIZER |
For determining the study's specific enrollment challenges and assessing potential sites. |
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| Market Research |
For augmenting SiteOPTIMIZER in establishing the essential criteria that sites must meet. |
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| GeoPopulation Analyzer |
For identifying the ideal locations for potential sites, based on populations of patients who met the key eligibility criteria for the study. |
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| StudyFORECASTER |
For projecting each potential site's ability to meet enrollment goals. |
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| TrialCENTRALNet |
For centralizing all existing and potential site information. |
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Results
- SiteOPTIMIZER and Market Research identified the ideal investigator as a hematologist specializing in ITP whose treatment philosophy aligned with the novel science of the investigational drug, and helped to establish a clear set of essential criteria by which to assess potential sites' individual strengths and weaknesses.
- The population mapping algorithms of GeoPopulation Analyzer provided 16 markets in which it would be most feasible to locate new investigative sites.
- The information gathered through SiteOPTIMIZER's surveys of potential sites enabled realistic enrollment projections with StudyFORECASTER about whether a potential site could actually recruit the required number of patients within the enrollment period.
- All told, this customized e-recruitment toolkit identified more than 90 potential sites that qualified as "superior." What's more, it revealed that only the top 40 would be needed, if sufficiently supported, saving the sponsor time, money, and effort in contracting and initiating sites.
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