Transparency in Biomedical Research and the Human Right to Health: An Empirical Evaluation of Registered Protocols and Published Clinical Trials

21 Pages Posted: 4 Nov 2020

Date Written: August 19, 2020

Abstract

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of new drug trials are industry funded. Many of these trials remain unpublished or have methodological flaws that distort the results.

The United States was the first country to respond. In 2007, the White House signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide universal access to a broad range of biomedical research information to be made available on the online platform “ClinicalTrials.gov.”

In our paper, we accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. We also assessed the proportion of industry-funded and independently funded trials and the relationship between funding and methodological flaws in clinical trials.

Our analysis reveals that the FDAAA has positively affected transparency patterns in clinical research. Poorly designed trials, however, remain a challenge to be overcome These flaws negatively affect the quality of information available, breaching ethical duties of sponsors and researchers and the human right to health enshrined in Article 12 of the International Covenant on Economic, Social, and Cultural Rights (ICESCR).

Keywords: Food and Drug Administration Amendments Act (FDAAA); compliance; biomedical research; human right to health; information

Suggested Citation

Marin dos Santos, Douglas Henrique, Transparency in Biomedical Research and the Human Right to Health: An Empirical Evaluation of Registered Protocols and Published Clinical Trials (August 19, 2020). Available at SSRN: https://ssrn.com/abstract=3693353 or http://dx.doi.org/10.2139/ssrn.3693353

Douglas Henrique Marin dos Santos (Contact Author)

Centro Universitário IESB ( email )

Brasília
Brazil

HOME PAGE: http://https://iesb.br/

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