Reviews of complete and uncensored clinical trial data by independent researchers help healthcare professionals and patients learn more about the true safety and efficacy of a medicine. To conduct an independent review, researchers need full access to clinical trial data from those that sponsor the research. Some sponsors, particularly pharmaceutical companies, do not want to disclose all clinical trial information, saying that it is ‘commercially confidential’ and could give an edge their competition.

Public access to this data is, however, in the public interest and should be fully disclosed. Reviews of the data can identify adverse drug reactions and expose medicines that do not work as effectively as claimed. Not only does full disclosure of clinical trial data protect patients—it also prevents healthcare budgets from being spent on medicines that are no better than existing treatments or do not work at all. Independent reviews expand our knowledge of medicines and help healthcare professionals and patients make better treatment decisions.

Health Action International advocates for increased access to clinical trial data in the European Union. Our action in this area has contributed to the adoption of a Clinical Trials Regulation by the European Parliament. Our sights are now set on ensuring the Regulation is properly implemented.

Recommendations for Policy-makers

Clinical Trials in the European Union: A Roadmap to Greater Transparency

Keys to Improving Access and Innovation of Needed Medicines in the European Union