Having a streamlined and transparent strategy when looking at the enrollment performance of sites throughout a clinical study is vital to achieving on-time enrollment. Implementing a plan to mitigate enrollment barriers and how to deal with underperformance at sites are keys to gauging which sites are best fit to achieve set enrollment goals, and which sites need to be closed to enrollment.
BBK Worldwide has moved! We recently changed office locations and let me tell you, it has been a time consuming and arduous process. Location, price, facilities, and staffing capacity are all important factors when it came to choosing the right location for BBK’s new corporate headquarters. As we searched for a new place to call “home,” we realized that a lot of the questions we had were similar to the questions clinical trial sponsors face when selecting sites for research studies. So, in honor of our recent move, here’s a fun, quick list of similarities between choosing a new office location and selecting sites for your research study.
In clinical R&D enrollment feasibility studies, I typically see all manner of questions aimed toward potential investigators that seek to establish (with accuracy) the number of patients they see, treat, and manage on a daily / weekly / monthly / quarterly basis. Typically, the question is confounded with layers of study eligibility criteria, and so the answer of course is rarely given with anything close to accuracy.
Social media listening programs observe and track social media activity, providing insights difficult to gather otherwise. When implemented in a patient recruitment campaign, these programs can gather information around a specific disease or condition, identifying active advocacy groups, common treatments, and challenges facing patients. But it goes even deeper than that, enabling you to implement the right strategies to speed your enrollment efforts.
Imagine doubling the size of a football field and the teams that play on it. Bigger territory and more players might require a reorganization of responsibilities on the field. Suddenly, it’s a new game. Players who once held supporting roles might find themselves in key positions accountable for scoring. But will their talents be a natural fit for the new job? Some will and some won’t. It makes sense. A similar scenario is playing out in the clinical research industry. The proliferation of multinational studies has broadened the clinical research playing field, bringing accountability for “scoring” up the chain. Country study managers (CSMs), responsible for the success of a protocol within their country, are now accountable for more complex and strategic activities, including patient enrollment — the clinical study equivalent to scoring.
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.
It’s a common practice in our industry (at least from my vantage point) to hear talk of the screen failure “rate” of any given study.
Today’s blog is brought to you by Kris Sarajian at BioPharm Clinical. Last week, BioPharm Clinical teamed up with BBK Worldwide, a valued partner for nearly a decade, to deliver a joint webinar on how new types of patient data are helping clinical operations teams improve research study feasibility and investigator selection in order to maximize patient recruitment (In case you missed it, you can get the slides and watch a recording on the BioPharm website).
We are excited to announce that BioPharm Clinical and BBK Worldwide will host a free, educational webinar to discuss new sources of patient pool demographic data and how they improve study feasibility and investigator selection. Featuring expert speaker Bonnie A. Brescia, founding principal at BBK Worldwide, the live online session will be held on November 15, 2012 at 12pm ET. RSVP to participate.
Co-Founder of BBK Worldwide Joan F. Bachenheimer wrote in a recent blog, “When options are limited, the medical community has an obligation to convey to patients the clinical trial options available to their patients.” Physicians play a crucial role in this and therefore it is important to foster relationships with them. Here’s an example of how.