Challenges and Opportunities in Clinical Trials by George DeMuth

Our Chief Business Officer was in San Francisco in early January for the JP Morgan Healthcare Conference.  There was a lot of activity with meetings and industry events during the week and most signs suggested a positive outlook for 2019 with the potential for continued growth in the healthcare sector.  The industry seems to be primed for this growth as it is currently configured at the confluence of good science, experienced leaders and the accessibility to solid funding options.  The year ahead looks to be promising for both sponsors and vendors, with innovative technology growing at a rapid pace.

Stat One staff has been performing clinical trial work for several decades.  In that time, we have been involved with numerous successful applications in both the US and EU across pharma, biotechnology, and medical device products.  In truth, bringing any product to clearance is a complex process that spans many facets of business, a lot of hard work, attention to detail, and follow through.  The approval of medical products requires operating in highly regulated environments across the world.  Not all regulations come from within regulatory bodies like the FDA, EMA, or PMDA.  Witness the impact of GDPR on collecting and storing patient data and the potential impact of Brexit on bringing new products to the UK.  While it sounds trite, change is a constant, even if the fundamental approaches to the work remain the same.

Successful companies need to harness scientific research, interaction with KOLs in the area of their products, obtain funding at the right time and manage budgets; manage vendors or conduct trials themselves; navigate the regulatory environment, ensure the safety of the patients who utilize the company’s products, and maintain quality throughout all steps.  Because we realize this is a daunting set of tasks, Stat One always understands we are part of a team with a single goal: obtaining success for our clients.

Our approach to statistical consulting and analysis is grounded in applying the right methods to the problem and, when necessary, accounting for the other factors a company is facing.  We work with our clients so that we jointly understand how the statistical approach and study design need to work with the broader regulatory and scientific setting of their product.

In the coming months we will provide a series of short articles on our website that speak to current trends while addressing topics of interest in study designs and strategies that we discuss with clients.

These include:

  • Factors to consider in choosing an adaptive or group sequential study
  • Sample sizes for common trial designs
  • Considerations for designing studies
  • Approaches to study randomization

 

Please check back with us in the coming months at www.statonellc.com or email: bdemuth@statonellc.com for more information.

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