Craftsmanship in Clinical Trial Study Design
July 6, 2016
Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including the Inner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project. Ryan also coordinates Rho’s Center for Applied Data Visualization, which develops novel data visualizations and statistical graphics for use in clinical trials.
Shann Williams has 10 years of experience managing clinical trials. She is a Sr. Director of Operations and the program director of the statistical and clinical coordinating center of the Transplantation Group for the division-wide consolidated coordinating center sponsored by the National Institute of Allergy and Infectious Disease (NIAID). In addition, Shann serves as Rho’s project management operational service leader, an internal expert sharing project management best practices, processes and training.
My dad is an expert carpenter and handyman. Growing up, I spent hours watching him work – furniture, flooring, painting, plumbing, roofs, siding, decks – you name it, he did it. I learned a lot from watching him and helping him, but I never accomplished his level of expertise and proficiency. It is not for lack of knowledge or ability; rather, it is a lack of practice and experience. I’m capable. My father is masterful.
Clinical trials are not so different from construction and craftsmanship. To be a successful clinical researcher, you need to coalesce expertise across a variety of domains – statistics, data management, project management, clinical operations, product safety, regulatory, medical writing – as you design, prepare, execute, and troubleshoot throughout the trial. The CRO industry exists because we provide specialty expertise in these areas, and many pharmaceutical companies are glad to have a trusted partner to manage various aspects of this work.
Yet, regardless of which CRO services pharmaceutical companies seek out, one task pharmaceutical companies have been reluctant to source to their CRO partners is clinical trial design. According to a recent press release by Cutting Edge Information, as recently as 2014, no Top 50 pharmaceutical or medical device team surveyed reported that they shared clinical trial design responsibilities with CROs.
This is not especially surprising. With their product on the line, pharmaceutical companies have a keen interest in retaining careful control over the study design. It is also a matter of practicality. Before seeking out a CRO to support management of your trial, it helps to have a well-constructed plan of how the trial should be executed. However, Cutting Edge Information reports that this trend is likely to change dramatically in coming years. By 2020, over 50% of companies they surveyed plan to share trial design responsibilities with CROs. Why the change?
In part, it’s due to the need for craftsmanship. When it comes to clinical trials, CROs offer a level of end-to-end proficiency built on decades of extensive trial management experience and specialization. When your job is conducting hundreds of trials for a wide range of clients and diverse therapeutic areas, you naturally achieve a high degree of expertise: a deep knowledge base, valuable foresight, honed skills, improved efficiencies, and the ability to operate deftly in a complex and highly regulated environment. As the ones most often implementing the trials, overseeing the day-to-day project operations, and conducting analyses, CROs are in the best position to identify the strengths and weaknesses of clinical trial designs.
With the pace of new drug and device development lagging, costs increasing, and pressure to get efficacious products to market building, clinical trial designs have come under growing scrutiny. Bad blue prints lead to less than optimal functionality or worse: a complete do-over. In the same way, even simple trial design errors will lead to less than optimal results. The need for a do-over can be cost-prohibitive or just plain disastrous.
By incorporating CROs in the design process, pharmaceutical companies will foster closer partnerships, reduce costs by leveraging efficiencies, benefit from the extensive experience CROs have to offer, and craft more effective trials. Independently, pharmaceutical companies and CROs are capable. Together, we are masterful.