As we strive at BBK to re-concept services and strategies that help sponsors retain the patients they enroll, we find ourselves discussing the places we routinely visit, and what keeps us coming back. For me this always gets me talking about food. There’s a sandwich shop in Jamaica Plain, my neighborhood in Boston, which I hit almost weekly despite pretty intense local culinary competition: El Oriental de Cuba, home of the best Cuban sandwich in Boston (yes, I know Chez Henri’s is also amazing, but I would argue a different sort of beast).
Given hectic schedules and competing priorities, including clinical care-, administrative- , and research-related activities, recruitment for a single study is often sidetracked, even given the best of site staff intentions. Add to that one or two recruitment challenges, such as a lengthy enrollment period for a population with a low incidence, a projected high screen-failure rate, and / or an incredibly crowded treatment landscape, and you can readily intuit that you will need a way to make sure that recruitment for your study stays front and center.
Note: This blog contains excerpts from Justin’s recent article on operationalizing and distributing new patient recruitment programs, published in the March 2013 edition of European Pharmaceutical Contractor.
Sunday is blog day. Maybe it’s because I am backed by The New York Times Sunday business section that always motivates me to think about the clinical research and development industry even as I am trying to take my proverbial “day of rest.” This week an interview with Steve Case, CEO of the venture capital firm Revolution, caught my eye... heart... and, mind.
In part one of this two-part series, I discussed positive trends in patient recruitment and how the sheer range of recruitment- and retention-related services, products, and solutions has exponentially increased, with innovation never stronger. While today’s trends in global patient recruitment are creating the opportunity for greater momentum than ever before, it’s important to strategically consider tactics based on site capabilities and the unique study at hand. How do you do this?
Agency Engages Untapped Audiences and Provides Clinical Trial Sponsors With Increased Return on Investment
While the push for sponsors to go global with clinical studies is old news, choosing the right sites and the right countries to host a particular study remains one of the industry’s most impenetrable challenges. Over the past few weeks, I have participated in several conferences on clinical operations improvements and remain baffled by the limited progress study teams have made in this area over the past five to 10 years. 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 these 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 patient in the least amount of time.
Enrollment goals – every site has them. As the study sponsor, you’ve made your projections and communicated your expectations to each principal investigator. They have all assured you that they’ll have no trouble meeting your goals. Perhaps even a few of them told you they can enroll more than your goal. No problem, right?
BBK Worldwide announced today an expanded suite of products that streamlines retention efforts at the site level. Among these products are the Ready. Set. Go.℠ Card (RSG℠ Card), Ready. Set. Go.℠ Ride (RSG℠ Ride), and Ready. Set. Go.℠ Minder (RSG℠ Minder). These products are customized for today’s clinical research coordinator who is tasked with multiple responsibilities and demands. Through the efficiencies these products create, the clinical research coordinator is allowed to focus his or her efforts on other study-related priorities.