April 01, 2018

Aiming for Transparency: Clinical Trial Disclosures in the United States and European Union

Darshan Kulkarni, Synchrogenix, Philadelphia, PA, Ashley Thomas, Baker Donelson, Washington, DC and Andrea Tunnard, MS Candidate 2019, University of the Sciences, Philadelphia, PA

The disappointing results of a new tuberculosis vaccine booster in clinical studies have raised questions about the transparency of data used to make regulatory and patient decisions.1 In a trial conducted by Oxford University researchers, parents of the infant trial participants in an impoverished South African population gave informed consent for administration of the experimental vaccine after they were told that the drug was demonstrated to be safe in animal trials. Unfortunately, it is alleged that the information provided was misleading at best and false at worst since the researchers withheld or “played down” information that was unsupportive.1  This, the latest in a salvo of concerns around a lack of transparency in clinical research, in combination with the empowered patient movement2 has forced a tipping point with  regulatory organizations like the Food and Drug Administration (FDA) and European Medicines Agency (EMA)3 requiring companies engaged in research to be more transparent with their processes and findings.

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