Can a New FDA Chief Improve Clinical Trials?
Dr Robert Calif
Dr Robert Califf, who led the United States Food and Drug administration in 2016 before taking several positions in the pharmaceutical and IT industries, is once again at the helm of the agency as its commissioner. Dr Califf’s supporters cite his position on potential clinical trial reforms and changes that may modernize the clinical trial enterprise, although some United States senators remain wary of his ties to the pharmaceutical industry that he will now regulate.
Clinical trials may benefit from modernization
Dr Robert Califf has spoken recently to the media and to clinical trial advocates, and he testified during a Senate confirmation hearing about his possible priorities as commissioner. At the hearing in December 2021, he stated that pandemic emergency preparedness and response would be the FDA’s main concern.
He also spoke about reforming or modernizing clinical trials. Dr Califf’s clinical trial agenda may focus on a number of changes that he has advocated for in the past.
KEY CHANGES
Some of the changes to current clinical trial practice Dr Califf has proposed include the following:
Conducting fewer and simpler clinical trials. Modernized studies would enroll larger populations and be designed to answer critical clinical questions that drive regulatory decisions.
Improving accessibility and diversity. Randomized studies would be conducted within practice settings, which in turn could help diversify the study population—that is, create meaningful subpopulations for analysis—and possibly improve care in underserved areas where access is limited.
This approach would include careful management of the digitalization of the clinical trial enterprise, with the hope that a digital experience would be inclusive of diverse and less educated populations
Increasing transparency. Real-world data would be generated and shared with all stakeholders—including patients—along with other information that may be accessed through electronic health records and medical claims. In addition, “negative” clinical trial results would be published, which can help inform researchers, participants, and patients.
Clinical researchers are committed to excellence. Their efforts ultimately help drive patient care. Changes to the clinical trial enterprise may streamline the industry’s bureaucracy and improve the quality of the research that regulatory decisions depend on.
Transforming the clinical trial experience with patient education
We develop creative solutions at the appropriate points of the patient journey and include all clinical trial stakeholders for recruitment, retention, and compliance. We also understand the importance of diversity and inclusion and help promote this to patients and professionals.