Hype or hope? Managing patient expectations for your next trial

Perhaps the best part about the clinical trial process is being able to observe the excitement and hope after promising drugs — especially therapies that could help a great deal of people — perform well in testing.

With all the uncertainties in the medical world, it’s only natural for us to celebrate the victories that point toward a brighter future for the people battling painful and debilitating illnesses. At the same time, however, the great press received by some successful trials can create unrealistic expectations for those involved in quieter, less-dramatic studies that remain very medically valuable.

A study last year, for example, found that half the patients considering participating in a phase 1 trial fully believed their cancerous tumors would shrink from the treatment, an assumption unfounded by the tenets of the study. While the source of their overly optimistic outlook wasn’t clearly defined, study author Dr. Udai Banerji called the results a red flag for clinical study managers. "This creates a challenge for health care professionals to manage expectations, but to do so without being patronizing or dismissing human hope," he said.

Even the scientists involved in the studies, however, can get caught up in the publicity hype. In Forbes, Dr. Chuck Shear of Pfizer remembers his devastation after the widely touted, $800 million cholesterol drug torcetrapib failed in phase 3 trials. “I know I entered an alternate reality that day … it must be something anyone in bereavement must feel. Something was gone that would never be replaced, a hole in my heart that will remain forever.”

The reality is that the information gained from clinical studies worldwide should be thought of as more a marathon than a sprint. Progress is being made, with 8,200 novel compounds developed between 1996 and 2014. But research shows the likelihood of a therapy moving from phase 1 to market remained at 11.6 percent between 2012 and 2014, less than the 16.4 percent achieved between 1996 and 1999 but more than the 7.5 percent gained from 2008 to 2011.

No one wants to downplay the valuable innovation inherent in drug trials, but neither should participants be given false hope or misled in any way about the odds of being cured in such trials.

What are some ways of managing expectations among trial participants? Consider the following:

  • Transparency that starts with the recruitment process is of utmost importance. Provide comprehensive print materials, optimize mobile communications, offer plenty of opportunities for questions and over-communicate throughout the trial.
  • Talk to patients about ways of managing their diseases or conditions that transcend the trial itself. “Instead of trying to dissuade patients from expressing hope or positive attitude, we might work with them to make sure they are planning for all possible outcomes,” advises Dr. Kevin P. Weinfurt on Ascopost.com.
  • Disseminate the results of all concluded clinical studies to the participants, explaining what they mean, describing how they’ll contribute to the scientific body of knowledge and delineating the next step in the research process, if any.
  • Work with the media on the production of balanced stories that note the overall failure rate of clinical studies while also emphasizing their value to the medical community.

Recognizing that most trials are statistically unlikely to produce dramatic, groundbreaking results is the first step toward establishing trust and acceptance among trial participants. Still, we can all take comfort that regardless of individual trial results, scientists will forge on to seek answers, just as Shear did following the failure of torcetrapib.

“Even after such a devastating result, scientists pick themselves up and get back to doing their life’s work: discovering and developing new medicines to benefit people around the world,” concludes John LaMattina in the Forbes article. “Chuck and others were no different. Soon they were hard at work on another important research project, one also designed to benefit people with heart disease.”

Let Artcraft Health design a marketing campaign that explains the full value of your next clinical trial.


BlogLindsey Kuhl