Four Axioms That Will Always Explain Successful Clinical Performance

Happy 25th birthday Applied Clinical Trials! There is much to celebrate given ACT’s active, extensive and insider coverage of a clinical research enterprise that has been remarkably productive in delivering important medical therapies while juggling high levels of inefficiency, development risk, and growing demand for capacity and expertise. I have had the privilege of being a subscriber and a contributing author and columnist to ACT for nearly the entire magazine’s history. During that period, the majority of operating conditions can be explained by four axioms that should serve as important insights into clinical trial operating success in the next quarter century.

(1) It is always about relationships. No matter how hard we try to drive speed and efficiency with new technology solutions and process improvements, or how tightly we manage study timelines, success always rests with the quality and caliber of our relationships. The time and care that we take to build expectations and solidify as a team; to establish alignment; to clearly delineate roles and responsibilities; to convey respect and establish trust; to invite and accommodate timely input; to give partners the support and room that they need to excel-time and time again these are the characteristics that define successful clinical performance. 

Research from a wide variety of sources has shown that there are a number of essential relationships that are neglected and often dysfunctional. Sponsor-contract research organization and sponsor/CRO-investigative site relationships are two such areas. Recent attention on improving the relationship between clinical research professionals and patients/advocacy groups/the public/healthcare providers/payers-and impassioned efforts to drive higher levels of engagement  with these communities-will go far in helping the clinical research enterprise to achieve success in the future.

(2) Investment in execution is as important as investment in strategy. We are an industry comprised of very bright and capable people. More often than not we devote substantial time and resources to plan and articulate strategy, only to under-invest in executing on that strategy. New technology tools and outsourcing models are but two examples of well-intentioned strategies that are not historically supported by consistent and well-integrated implementation. High levels of fragmentation within major and mid-sized sponsors and the difficulty juggling both legacy and new programs simultaneously contribute to poor execution. A few companies are seeing faster adoption of innovative technologies and better performance by devoting far greater time and attention to mapping out detailed implementation plans, facilitating upfront buy-in across functions and expecting more consistent practices.

(3) We must strive for the highest levels of transparency and disclosure. Clinical research stakeholders readily agree that transparency and disclosure are the critical building blocks of trusting and lasting relationships. Moving forward, we must commit ourselves to improving transparency and disclosure and to raising our standards as high as possible. This includes not only increasing the amount of and access to data, but also to providing it in languages and terminology that can be best understood by all communities.

Industry-wide behaviors often belie our general agreement with this axiom. To cite a couple of examples: operating and financial data often is not shared between sponsors, CROs and sites, and public and private sector conflicts-of-interests are not consistently and, in some cases, adequately disclosed.

 (4) Balance must be struck between scientific excellence and feasible execution. Scholarly research has consistently shown that scientific and logistical complexity is inversely related to high performance and

efficiency. As drug development programs have become more complex, so too have they become costlier, riskier and longer in duration. Partners in any relationship succeed when their contribution is feasible and achievable. For our study volunteers, feasibility includes not only access to clinical trials but also convenience and comfort. Today’s study designs have the highest relative number of procedures and eligibility criteria on record, and our operating models often involve complex and fragmented, poorly coordinated global teams of internal and contract service personnel. Time will be well spent challenging great drug development science at the outset so that it can be feasibly executed and all partners can succeed in supporting it. 

Best wishes and congratulations to ACT on its 25th birthday. Here’s to the next 25!

Ken Getz, MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both based in Boston, MA. email: kenneth.getz@tufts.edu