JUNE - 20238MOVING FROM "BETWEEN A ROCK AND A HARD PLACE": A NEW APPROACH TO COMMUNITY-BASED RESEARCHIn the current "Golden Age of Oncology," clinicians and patients are employing transformational systemic therapies, including genomically-targeted drugs, immune checkpoint inhibitors, and novel cellular constructs. While these unprecedented advancements have significantly improved patient outcomes, a constraint exists in the clinical trial process.Recently, I had lunch with a newly retired medical oncology clinician/researcher. Ron is NIH- trained with a track record of successful community-based oncology research. We got on the topic of clinical trials, especially in community settings. We celebrated the recent advancements, then commiserated over the major challenges. Despite being "between a rock and a hard place" ­ as Ron said­ community-based research has the potential for greater success and more patient impact if the approach is shifted, I believe.The Big ChallengesIn recent years, over 25 percent of Investigational New Drugs (INDs) approved by the FDA have been for cancer. This trend shows no sign of slowing, with about 40 percent of the pharma pipeline focused on oncology. The only pathway for approval of these therapies is through clinical trials.Unfortunately, less than 8 percent of all cancer patients are offered a clinical trial despite a >50 percent enrollment rate for patients offered trial participation. These numbers are even more dismal for minority populations. If it were easy to do, accruing would not be a problem. But the single-digit rate shows it isn't. Among the challenges, these weigh the heaviest.1.Infrastructure Requirements and Investment. The specialized infrastructure and talent needs for clinical research are substantial: back-office operations to in-clinic provider support, with integrated procedures smoothly linking processes. Back-office talent for areas such as compliance, regulatory, legal, finance, accounting, and IT with experienced managerial oversight are essential but are costly to identify, recruit, and retain ­ let alone conduct cohesive operations. Putting together an effective team at the scale needed, especially in the current competitive labor market, can take months, or longer.To top it all off, financial challenges loom large. While leaders are challenged to "break even," the prospect of a significant investment in clinical research infrastructure, coupled with a tenuous pro forma on research productivity, is a "bridge too far."2.Contacts.In the high-stakes pharma world, "time is money." For this reason, sponsors and contract research organizations (CROs), who conduct research operations on behalf of the sponsor, prefer to engage with researchers who have a proven track record of delivering timely, high-quality trial results. Without established relationships, new researchers may find it difficult to attract sponsor or CRO attention, and trial access slow to ramp up.3.Physicians Buy-In and Sustained Engagement.Nearly all oncologists fully support clinical trials as a necessary process for new drug approval, in concept. However, in practice ­ George W. Daneker Jr., MD, System Executive Leader, Oncology Service Line, SSM HealthByIn My OpinionGeorge W. Daneker Jr
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