Co-opting of ClinicalTrials.gov by Patient-funded Studies

In this commentary, the authors propose additional safeguards for studies listed on ClinicalTrials.gov, an online registry administered by the National Institutes of Health. They argue that not all of the studies listed comply with ethical, scientific and regulatory research standards for humans and often use confusing or misleading language that implies scientific validity. Specifically, they highlight “lung disease-related studies that have not been reviewed by the FDA and are pay-to-participate” as an area of concern. To address this, the authors outline several measures to improve transparency, preserve the registry’s integrity and ultimately protect prospective study participants from questionable and/or costly clinical trials.