Pharma companies looking to put together post-approval studies in the near future may be in for a big surprise: Competition for sites is heating up. Not only do post-approval studies represent the fastest growing area of clinical research spending—currently hovering around 23 percent, according to Thomson CenterWatch, the Boston-based information services company—but the number of FDA requested post-marketing studies has shot up from 30 percent in the late 1990s to 75 percent last year, according to the Tufts Center for the Study of Drug Development.
Critical to convincing sites to participate in post-approval studies is recognizing how post-approval studies differ from pre-approval trials, and why sites elect to participate in these programs. Not only are the types of sites and the goals of the research different, but the reasons that motivate sites to participate can also vary between the pre- and post-approval study groups. However, winning site participation ultimately rests in creating compelling post-approval programs that have real-world impact, answer important questions, cause minimal practice disruption, and provide enough value to participants to justify their time and effort.Say No to the Status Quo While some post-approval studies possess inherent positive-characteristics for driving site participation, few company sponsors have an overall strategy or consistent approach for convincing sites to sign up. Part of the problem is that post-approval studies do not even have a consistent home within many sponsor companies, let alone a consistent strategy that will progressively build networks of post-approval investigators. On one hand, you have sponsors that clearly distinguish the strategy, planning, and management of post-approval studies through different teams, technologies, and processes. Others manage post-approval studies through their clinical development organizations. While the former approach may be more likely to hone programs to the unique needs of post-approval sites, the latter offers cost efficiencies in leveraging—not duplicating—internal resources. Obviously, both approaches have their advantages. Regardless of where post-approval studies sit in the operational hierarchy, a clear understanding of the unique requirements of post-approval studies is the key ingredient, whether a study is launched to monitor safety or to demonstrate product value.
Fortunately, there is an opportunity for sponsors to outperform the competition in post-approval study participation. Leveraging this opportunity starts with understanding some of the unique aspects of the post-approval world, and the need for post-approval research programs to attract the attention of real-world clinicians.
Competition for Sites Post-approval studies compete for the participation of sites. Almost by definition, post-approval sites are real-world physician offices or hospitals focused on patient care, and therefore, not focused on clinical research. Most physicians have limited capacity to add any additional work without trade-offs in their practices. And, most hospitals are economically constrained and leery of diverting resources away from core objectives. Those that elect to participate can rarely scale up to participate in more than a few simultaneous studies—and if they did, they might be less representative of the real-world clinical practice that most post-approval studies are trying to sample. As a result, post-approval sites tend to participate in far fewer studies than pre-approval research sites do.
Adding to the competition for sites is the fact that post-approval studies tend to be larger than pre-approval studies for two reasons: They are designed to detect differences in larger, more diverse patient populations than were available for the pre-approval studies, and post-approval studies that are aimed at clinical relevance and contain large patient numbers are often compelling to physicians reading publications. With larger studies by more companies in the same disease areas—diabetes, coronary artery disease, and oncology, for example—competition for sites increases. And, while site payments should be at the appropriate market level for the work involved, the ability to recruit sites cannot be overcome with increased payments.