Report Calls for Full Transparency on Trial Results, Indefinite Archiving of Master Files

February 21, 2013
Drugmakers should be required to maintain clinical trial master files indefinitely unless national legislation says otherwise, according to a draft report on the European Commission’s proposed clinical trials regulation. The information could be stored in the EU clinical trials database if necessary, it adds. “Should a sponsor come under investigation for misconduct, the clinical trial master file would be vital,” writes Glenis Willmot, rapporteur for the EU Parliament’s Committee on the Environment, Public Health and Food Safety. Sponsors that fail to publish their results within one year of a study’s end should be subject to fines from the relevant member states, Willmot adds. The commission proposed that trial master files be archived for five years.
International Pharmaceutical Regulatory Monitor