Legal scholars at Yale tackle clinical research openness in policy paper
“Despite the public health significance of the information gathered through clinical research, much of the data is withheld, missing or inadequately disclosed,” according to Margaret McCarthy, Jeanie Kim and Joseph S. Ross of Yale Law School. “This lack of transparency has sweeping negative consequences for medical research, regulation, clinical care and the healthcare system.”
Last week, Yale’s Collaboration for Research Integrity and Transparency (CRIT) released a new white paper, entitled “Promoting Transparency in Clinical Research: Why and How.” The trio of authors describes “the harms caused by the lack of transparency, the benefits of increased clinical trial transparency for researchers, regulators, clinicians, payers and policy makers and the current status of transparency efforts.” Created by the faculty and staff of CRIT, the document elaborates on ways to improve prospective clinical trial registration, results reporting and data sharing in an effort to balance the disparate requirements of researchers, regulators, policy makers and clinicians.
As the white paper explains, clinical research produces information that is essential to the way people understand medical products. Drug companies and researchers run clinical studies to determine whether a biomedical discovery that appears promising can be developed into a safe and efficacious medicine. After the researchers perform laboratory testing and preclinical studies on animals to determine basic information about how a given drug might work as a treatment, they engage in clinical trials with people to see how the “drug, biologic or device” affects the human body. Could it be too toxic for human usage? What kind of dosage level is safe? What are the potential harmful effects? How does the substance interact with other chemicals?
After clinical researchers obtain such data, the U.S. Food and Drug Administration can make an informed decision about granting market approval of pharmaceuticals and medical devices. Doctors and patients can also use this data to decide whether they want to prescribe or use those products. However, according to the white paper, “Despite this public health significance, much of the data from clinical trials are withheld, missing or inadequately disclosed.” The CRIT authors recommend three critical actions needed to achieve “clinical trial transparency.”
The first step, they say, is registration of clinical trials at the beginning of the study. This plan would entail a study protocol and statistical analysis plan, clearly elucidating research objectives and endpoints and plainly describing the study goals and design for the scientific and clinical communities.
The second step is “public reporting of summary-level results.” This measure would minimize unnecessary duplication of unsuccessful research and ensure that people’s collective understanding of a product’s benefits and safety is not distorted by unreported research findings.
The third idea advocated by the white paper is to share the clinical trial data and all of the documentation to support the data with independent researchers. This would enable the reanalysis of research “without a vested interest in positive results” and the combined capability to obtain additional inquiries.
According to the Yale researchers, all of these measures would allow for “important checks and balances necessary” to ascertain that medical products research is performed and explained in a scientifically accurate manner.