Throughout the evolution of clinical trials, patient enrollment has remained the most confounding element of timely trial completion. From the site perspective, the challenges are many. It is critical to mobilize strategies that minimize cost, maximize recruitment and avert patient attrition.
The perspective of the Principal Investigator also is an essential element in the philosophy and underlying tone of enrollment success (or lack thereof). Some take on a study knowing target enrollment will not be met, some use a formula to achieve the bare minimum to make the study profitable for the site and some clearly do not use any formula at all. Securing site commitment to patient recruitment strategies requires gaining insights into sites’ motivations and challenges.
So what are the chief impediments to patient enrollment, from a site perspective? Research supports the following: insufficient volume of patients at the practice level who meet study criteria, lack of study awareness among potential referring physicians and absence of study awareness materials targeted to patients. Despite these challenges, some sites may fail to follow sponsor-funded and approved patient recruitment programs, known as centralized recruitment plans. I frequently ask myself why a site would choose NOT to utilize any effort to support enrollment, particularly those efforts available at no cost to the site. It would seem logical to encourage study coordinators and staff not only to use centrally provided materials and advertising, but to welcome the effort aggressively. Global recruitment firm Acurian surveyed sites’ perspectives on central recruitment efforts, finding a growing satisfaction among sites. Still, almost 40% of sites were on the fence. I think central efforts, combined with sites’ customized efforts, produce maximum results.
Site selection arguably is an arduous task that requires both operational and regulatory acumen. Once selected, the site risks compromising future selection if enrollment is not met. Therefore, an internal vetting process is recommended before one ever commits to performing a study. A detailed and consistent internal analysis of the sites’ projected performance should help guide the PI’s decisions. Though it may seem obvious, it cannot be overstated: the first consideration in accepting a study should be access to patients.
Once you have accepted a study the next critical element for hitting enrollment targets is to obtain maximum buy-in and understanding of the study from investigators and staff. One strategy is training staff on the expectations of the enrollment strategy to meet its goals. This may occur in weekly staff meetings that focus on ongoing enrollment initiatives. A weekly discussion holds staff to their commitments and follows the progress of enrollment as it compares to projected timelines. I also recommend creating a report with responsibilities, strategies and outcomes documented, to be discussed by the study team.
In many cases the site is responsible for selecting and executing strategies at its own discretion. Once a plan has been created, asking the sponsor for monetary support is an easy task and, if the plan is supported by metrics, often is approved. As with any partnership, many variables contribute to its success, including the establishment of rapport, trust and mutual commitment to study goals among sponsors, CROs and sites. From these relationships come the enthusiasm among sites to embrace and execute recruitment strategies. Taking the time to work in tandem toward common goals actually may be the best recruitment strategy of all.
Successful planning and budgeting for patient recruitment should be top of mind on all studies. The recruitment budget should be seen as equal in importance to the overall site study budget. This type of budget planning should be based on historical data, thoughtful preparation and insight by all study staff involved. The intricacies of the protocol must be understood. You will face additional challenges if competing studies are on board.
Finally, invest in your staff and don’t expect clinical staff to become overnight experts at managing the intricate details of planning and executing a recruitment plan. Clinical staff can learn the elements of marketing, advertising and recruitment principles, but they must be taught and have opportunity to grow this expertise. A dedicated team member sometimes can be afforded and can pay off in the long run; however, training options are varied. Many webinars are offered at a low cost and, in some cases, at no cost. Encourage staff to participate and learn, and reward them for their motivation. Many new concepts to reach patients are acceptable. Reward creativity and monitor practices and principles of outreach and recruitment. The internet and social media offer many opportunities, yet good recruitment practices and regulatory guidelines must be followed.
Approach recruitment and retention with new vigor and an open-minded approach, plan, budget and ask for support. You may be amazed at the response from the sponsor, the CRO and the team as a whole.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multidiscipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas.
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