Site Selection & Enrollment Feasibility for Global Patient Recruitment

Site Selection & Enrollment Feasibility for Global Patient Recruitment

Posted by BBKWorldwide on Tue, May 12, 2015

Site selection for global patient recruitmentWhile the push for sponsors to go global with clinical studies is old news, the industry has been working hard to develop and invest in ways to choose the right sites and countries. Ultimately, site selection matters because investigator sites are the only place where study volunteers can participate in clinical research. Enrollment is the end game – further drug development, regulatory submissions and marketing are contingent on having this data.

That said it makes sense to start from the final step – patient enrollment. Begin by analyzing the protocol from a patient recruitment perspective – its particular enrollment challenges, and compare them to a set of patient-related factors in each country in order to determine which countries are the best fit for the study. Effective site selection is dependent on identifying the countries that have the fewest recruitment barriers and are likely to enroll the most patients in the least amount of time. Sounds logical, but perhaps not so simple.

Preparation for site selection goes beyond searching by country and specialty – it requires taking a deep dive into subspecialties, prescribing habits, competing studies, publication histories and associations. You will of course need access to in-depth analytics from hundreds of multinational studies in every indication where data is reported. Fortunately, there are many new sources to capture this data than ever before.

We’ve developed the following list of guidelines to help ensure the selection of optimal investigative sites for your next global patient recruitment campaign.

  1. Review the protocol from the target patient’s perspective. Consider all inclusion/exclusion criteria carefully.

  2. Perform a competitive analysis to determine which existing studies might draw on the same patient pool.

  3. Create an ideal patient profile based on the protocol and competitive analysis. This profile should include both medical and psychographic requirements.

  4. Create an ideal investigative site profile based on the protocol and competitive analysis. It should take into account the recommended level of principle investigator (PI) involvement.

  5. Carefully craft a list of questions for the PIs that will show how close each potential site comes to the study’s ideal site profile.

  6. Weigh the questions based on which characteristics are the most important to this study’s successful patient recruitment.

  7. Prepare and send out an engaging invitation to PIs that accurately positions the.

  8. Collect answers and analyze responses according to the assigned weighting. This will generate a quantitative ranking of all possible sites.

  9. Continue the vetting process with only the sites that are most compatible with the protocol.

For more insight into how today’s increasingly complex clinical research environment demands the right country and site to ensure trial success, download our latest eBook: Successful Site Selection.

Successful Site Selection eBook

Topics: Patient Recruitment, Site Selection