Managing the stress of negative clinical trial results
The good news: The worldwide success rate of clinical trials is finally rising again, after falling from 2004 to 2011.
The bad news: That doesn’t necessarily make the failures easier to swallow, especially if you’re the scientific mind setting your sights on impacting medical history.
A recent study shows the success rate of all trials (the percentage of tested compounds making it to market) averaged out at 11 percent between 2012 and 2014, marking a nice hike over the 7.5 percent average logged in the three years previous. Analysts attribute the improved clinical trial results to growing pipelines that helped boost Phase II and Phase III success rates, with a greater number of compounds eliminated during Phase I apparently preventing costly failure later on. In total, 41 novel molecules were approved by the FDA in 2014, and 45 in 2015. Nature.com defines the successes as “a wave of immune-oncology products and anti-infectives boosted by commercial successes in the antiviral space” as well as “hot spots in innovation” in long-stagnant fields such as cardiovascular and gastrointestinal disease.
That upward trend is encouraging, but may be little consolation to the hardworking scientists and trial managers on 89 percent of the trials that failed, nor to the trial sponsors spending big bucks on the development process. Eli Lilly’s disappointing conclusion last year of testing on Solanezumab, for example, was a major blow to both researchers and the Alzheimer’s community. “We are disappointed for the millions of people waiting for a potential disease-modifying treatment,” noted Eli Lilly president John Lechleiter in a statement afterward.
When the stakes are as high as that, how can researchers optimize stress management and maintain enthusiasm for further research? Online sources offer some suggestions:
- Recognize the potentially damaging effect of the failure on your psyche. “Failure is painful, disappointing and demoralizing,” writes psychologist Guy Winch on Psychology.com. “When we fail we often generalize the experience in sweeping and self-punitive ways, and draw incorrect and unnecessary conclusions about our general intelligence, abilities, capacities and even about our ‘luck in life’ or what was or wasn’t ‘meant to be.’ The only thing we can conclude for sure after a failure is that we were unsuccessful at that particular task/goal, in that particular time, in those particular circumstances.” Instead, Winch says, you should strive to “Recharge your motivation by reconnecting to the reasons you began pursuing your goal in the first place.”
- Focus on publishing your results as a contributor to the body of medical knowledge. "We have an ethical obligation to research participants of clinical trials to use their information to contribute to generalizable knowledge," notes Dr. Monique Anderson in Forbes. “(And) for researchers, it is critically important to know the results of any trials involving investigational medical products, regardless of the outcome. This helps to both foster innovation and reduce duplication of clinical trials, especially those involving medical products which led to harm or that had no benefit."
- Expect the financial impact of continual failures to spur change. “The only silver lining to this cycle of failures is that it will facilitate a change in the industry,” writes Ralf Huss on Clinicalleader.com. “The financial pain of trial failure will eventually encourage pharma to change its approach and processes to be more efficient and successful in the long term.”
- Take heart at the aforementioned upward trend in success rates. The authors of the Nature.com study predict the industry shift away from a “quantitative shots on goal approach” will continue to help. “We also see a shift toward more innovation coming from smaller companies, with external innovation sourcing and effective partnering models becoming the source of competitive advantage for large pharmaceutical companies,” they write.
Contact Artcraft Health for help in developing an effective marketing campaign announcing your clinical trial results.