Trials fail due to poor design. Don’t let yours be the next!

Flawed methods in clinical trials have had a big part to play in the poor track record for Neuroscience drug development with consequences for both patients and the pharmaceutical industry.  Nowhere are the consequences for patients more acutely felt than in the area of Alzheimer’s drug development where the industry counts just three Alzheimer’s drug wins in 13 years and 101 losses, according to Pharmaceutical Research and Manufacturers of America (PhRMA). Failed trials also have big consequences for companies, often losing organizations billions in capitalization. In many cases the losses could be avoided through better trial design[1].

Research has shown that clinical programs have a high failure rate, even when drugs are known to be effective. For example, Khan et al. (2002)[2] reviewed the data from nine antidepressants approved by the United States Food and Drug Administration between 1985 and 2000. Of the 92 treatment arms reviewed, less than half showed statistically significant separation from placebo.

Surely we can be doing more at the trial design stage to avoid failed trials. Newer methodologies, such as adaptive designs, patient enrichment and risk based monitoring have been discussed extensively but adoption by the industry has been slow.

In the upcoming webinar sponsored by Covance Inc., leading industry experts share their insights and experiences gathered in the design and execution of novel trial designs in psychiatry – designs focused on speeding availability of effective treatment to patients, selecting patient subgroups most likely to respond and minimizing placebo response rates.

Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, shares his thoughts on how adaptive designs can reduce length and increase flexibility in exploratory trials. Prospective subgroup analysis and wider dose ranges can be studied without increasing sample size allowing for more efficient use of trial budgets.

Sanjeev Pathak, MD, Senior Medical Director at Alkermes Inc., will review how his group has adopted methodologies that reduce the impact of placebo response while lowering sample size by 20-40%. He outlines his group’s reasons for adopting novel trial designs and lessons learned from discussions with regulators.

By attending the webinar you will –

  • Explore how novel trial designs can benefit your Neuroscience development program
  • Examine the pros and cons of implementing adaptive and enrichment designs
  • Identify barriers to adoption and how to overcome them, including organizational, regulatory and resource related barriers

If you’d like to hear more about how trial design can help improve your chances of success, then join me on November 17th for the Covance-sponsored webinar “Innovation in psychiatry trial design – How to improve the probability of success”.

Webinar Details and Registration
Monday, November 17, 2014
10 am New York, US/15:00 London, UK
60 minutes including Q&A

[1]Becker RE, Greig NH. Why So Few Drugs for Alzheimer’s Disease? Are Methods Failing Drugs? Curr Alzheimer Res. 2010 November 1; 7(7): 642–651

[2]Khan A, Leventhal RM, Khan SR, Brown WA. Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database. Journal of Clinical Psychopharmacology. February 2002 – Volume 22 – Issue 1 – pp 40-45

Leave a Reply

Your email address will not be published. Required fields are marked *