By Wayne Bowden
A 2018 study out of MIT Sloan School of Management showed only 13.8% of drug development programs lead to FDA approval. That’s an improvement from previous estimates, which hovered at around 10%, but still an alarmingly high failure rate. In today’s competitive market, reducing failure rate is one sure way to maintain R&D returns.
While issues around safety and efficacy cause most clinical trial failures, lack of funding, poor study design, challenges around inclusion and exclusion criteria, low patient recruitment and retention, and simple mismanagement can all send a trial down the tubes.
Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.