About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.


Promoting Transparency in Clinical Research

November 3, 2017

Clinical research generates information that is critical to our understanding of medical products. Researchers and pharmaceutical companies conduct clinical studies to see if a promising biomedical discovery can lead to a safe and effective medicine for patients. Investigators start with laboratory testing and preclinical studies that provide basic answers about a treatment’s mechanism. Then, studies involving human participants provide a clearer picture of how the drug, biologic, or device will interact with the human body: Is the drug toxic or safe to use? What is the appropriate dosage? What are the side effects? How does the drug interact with other substances?

The information gathered through clinical research supports market approval of medical products by the U.S. Food and Drug Administration and is also key to patients’ and clinicians’ abilities to make informed medical decisions about those products. Despite this public health significance, much of the data from clinical trials are withheld, missing, or inadequately disclosed.

There are three key steps toward achieving “clinical trial transparency”: (1) prospective registration of clinical trials; (2) reporting of results; and (3) sharing underlying, analyzable data.

First, registration of clinical trials at the start of the study, including a study protocol and statistical analysis plan, with research objectives and endpoints clearly specified, provides clear documentation of study goals and design for the scientific and clinical communities. Second, public reporting of summary-level results limits unnecessary duplication of unsuccessful research and ensures that our collective understanding of a product’s benefits and safety is not distorted by unreported research findings. Third, sharing the trial data, along with all supporting documentation (like data dictionaries), with independent researchers allows research findings to be reanalyzed without a vested interest in positive results and pooled together for further inquiries. All three steps provide important checks and balances necessary to ensure that medical products research is conducted and described in a scientifically accurate manner.

Today, Yale’s Collaboration for Research Integrity and Transparency released a new white paper, titled Promoting Transparency in Clinical Research: Why and How. We focus on 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.

The white paper offers a roadmap for improvements in prospective trial registration, results reporting, and data sharing, balancing the competing needs of researchers, regulators, policy makers, and clinicians.