Dr Michael Silverman, principal at BioStrategics Consulting Ltd, discusses clinical trial site selection and its impact on operational success.
When we consider operational success, there are two distinct aspects: Getting the Right Data and Getting the Data Right. The first concerns site selection, standardized clinical assessments, centralized lab procedures, management of clinical supplies and management of biological specimens. The second concerns case report form design, clinical monitoring, data entry and management, statistical programming and analysis, and quality assurance.
This week I would like to discuss Getting the Right Data, and specifically clinical trial site selection.
Site Selection Considerations
Getting the right data starts with the clinicians who enroll, treat and evaluate the clinical trial patients. When choosing clinical trial sites, there are a number of factors that require careful consideration (see below), but first and foremost should always be the sites ability to gather high quality data. This broad statement encompasses the experience and qualifications of the site staff, the availability of suitable patients who meet the protocol entry criteria, and the ability to perform the required clinical assessments.
CONSIDERATIONS IN SITE SELECTION
- Experience and qualifications of the investigator
- Experience and qualifications of study coordinator and other staff
- Availability of suitable patient population
- Availability of specialized diagnostic or therapeutic equipment
- Track record with previous, similar trials
- Academic or “thought leader” credentials
- Geographic location (including international)
- Anticipated rate of patient accrual
- Timing of Institutional Review Board meetings
- Contractual and budgetary negotiations
- Regulatory history (FDA audits, “blacklist”)
Site selection requires due diligence on the part of the sponsor to ensure that the proposed clinical trial site meets all the considerations listed above. One of the most important decisions the sponsor makes when embarking on a new clinical trial is the choice of the principal investigator. It goes without saying that the principal investigator should be experienced and qualified in the disease area, but also in the running, coordination and leading clinical studies. The role is not an easy one, and requires the individual to be both tough on fellow investigators and available to help think through the myriad of challenges that arise during a clinical study. It is also customary for the principal investigator to play a key role in recruiting patients, analyzing data, publishing the results and speaking at conferences.
One area that requires careful attention in the site selection considerations is that of the anticipated rate of patient accrual or recruitment. It is this author’s experience that every clinical trial center over estimates the number of patients they can recruit in a given time. One simple method one can utilize to assess the ability of a clinical trial center to recruit a specific number of patients that meet the protocol entry criteria over a given period is to perform a retrospective review of their patients to determine the actual number of patients that meet the inclusion and exclusion criteria of the protocol over a several month period. This is usually a reasonable estimate of what the center can actually recruit. If, on the other hand, significant advertising of the clinical study is planned, then it is possible that the recruitment could be a little higher than the historical trend.
Dr Michael Silverman is the principal clinical consultant at BioStrategics Consulting Ltd., a clinical development consulting company based in Marblehead, MA, with business interests around the globe. Dr Silverman would be delighted to hear your thoughts on today’s blog, your experiences, or anecdotes and of course, your questions. To make comments or ask questions, click on this link.
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BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries, including: Clinical development strategy and management, conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials, IND planning and preparation, FDA and other regulatory authority submissions, meetings, and related interactions, Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas, New technology assessment, due diligence, and program planning, Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).
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