The State of Adaptive Trials

Keep Up or Get Left Behind

With the February 2010 FDA guidance released on adaptive clinical trial design, there has been no shortage of media coverage surrounding adaptive clinical trials. Combine this with the pharma industry's continued economic woes and the potential for adaptive designs to shorten the development time and lower development costs and the time seems ripe for adaptive designs to move up the traditional product/service adoption curve and leave the "innovator" phase.

But inertia is a powerful force. Drug developers have been conducting clinical trials in basically the same manner for decades. Industries, companies, departments, and careers have been built on this model.

Adaptive trails will continue to pick up steam over the next two to five years and the companies that can both design and execute these trials have the potential to differentiate themselves in the marketplace and from their competitors, but only if they learn from those who have gone before them. This report provides insight and advice from people who have been down this road before and provides areas of potential growth and decline in adaptive design types and phases of clinical development.

Report Contents:

This report contains the following five sections:

1. Motivations for conducting adaptive trials – For most organizations, sponsors and service providers, getting an adaptive trail off the ground still makes a fair amount of effort, both internal and external “selling” are needed to convince someone of the benefits adaptive designs provides. And in most cases the major benefit articulated is that the trial can get finished faster than using a traditional approach. In this section, respondents explain their motivations for conducting adaptive design trials.

2. People are the cornerstone - This section focuses on how adaptive designs are still rather young from an innovation or adoption curve standpoint. The take-away is that people are still the most important attribute for a successful adaptive trial. Sponsors and service providers need to understand this and develop strategies that incorporate strong communications between and within functions.

3. Adoption trends - Gives an overview of which types of adaptive designs and which phases of development are going to see the most growth over the next two to five years.

4. Operations and site dynamics – A brilliantly designed adaptive design is not worth the paper it is printed on if an organization cannot operationalize it. This section focuses briefly on which functions are most impacted and provides suggestions for how to motivate sites to participate in adaptive clinical trials.

5. Outsourcing – Adaptive trials are highly outsourced activities and there is no substitute for experience. In this section, respondents provide their most important attributes a service provider must exhibit.

As always, an appendix of Charts and Graphs is also included within this report with responses to all questions asked in this study.

Companies Mentioned:

Sample Charts & Graphs:

  • Berry Consultants
  • Celerion
  • Cytel
  • Covance
  • GSK
  • INC Research
  • ICON
  • Kindle
  • MD Anderson
  • Novartis
  • Omnicare
  • PAREXEL
  • Pfizer
  • PPD
  • Quintiles
  • Roche
report_chartsample_adaptive.png

Other Measurements Reported:

  • Study type and Phase trends
  • Adoption drivers
  • Phase-specific usage
  • Study type-specific usage
  • Most popular adaptive designs three years from now
  • Service provider perceptions
  • Sponsor’s view of opportunity (design or execution)

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