October 18th, 2017

FDA Says Clinical Trials Are Too Confusing – Even for Doctors


If doctors and nurses don’t understand basic clinical trial information, why would they refer their patients?

A recent Tufts CSDD study of more than 2,000 doctors and nurses found that, though the majority feel comfortable discussing clinical trials with their patients, they refer fewer than 0.2% of their patients. The study concludes that clinicians have limited access to information, and the materials they do receive are insufficient. Even worse, nearly 30% of physicians and 45% of nurses report never receiving an initial or follow-up contact from a clinical trial after referral.

Thanks to a new study from the FDA’s Office of Prescription Drug Promotion (OPDP), we may have some insight into the root of the problem. After surveying primary care physicians and endocrinologists around the country, the OPDP discovered that the majority of medical professionals could not correctly interpret clinical trial data and research findings in promotional materials. This should be a wake-up call to trials that something in their recruitment strategy needs to change.

Failure to Communicate

The FDA conducted the OPDP study to better understand the impact of clinical trial promotional materials on medical professionals, and discovered a major hurdle to recruitment. They found that “many doctors could not correctly define ‘randomized controlled trial’ and that majorities did not understand terms such as ‘re-randomization’ and ‘non-inferiority randomized controlled trial.'” Even fewer could define phrases such as “modified intent-to-treat,” “adjusted mean,” or “last observation carried forward.” Even if clinicians understand the science behind the trial, they’re tripped up by the vocabulary that clinical trials use to convey their findings.

The FDA’s findings contextualize clinicians’ egregiously low referral rate – why would they refer patients to a trial if they’re unclear about its purpose or results? This should be concerning for clinical trials; roughly 29% of trial costs can be attributed to patient recruitment, and any ineffective method puts the study at risk for delays or closure. As it is, acquisition and retention issues contribute to skyrocketing R&D prices, costing clinical trials up to $37,000 a day. Without clearer communication and data transparency, trials will continue to spend valuable resources on materials that confuse clinicians instead of convincing them to refer their patients.

A Solution in Digital Channels

Communication between clinical trials and medical professionals needs an overhaul, but those reforms are not enough to remedy the systemic problems with patient recruitment. Approximately 90% of clinical trials fail to meet their recruitment goals on time, which begs a more holistic approach to outreach. Traditional methods have their place in a recruiting strategy, but trials should also take advantage of the opportunities that digital marketing has to offer.

By building out robust digital advertising campaigns, clinical trials can meet patients on the platforms they frequent. More people than ever are seeking out health information via digital channels, and trials can improve their ROI by capitalizing on this trend. The obstacle of recruitment requires a multifaceted strategic approach for both physicians and patients to improve access to information for everyone.