Researchers from Germany’s Institute for Quality and Efficiency in Health Care call today for clinical study reports (CSRs) from clinical trials to be made publicly available.
9th October 2013
In a paper published today in PLOS Medicine researchers compared information about 101 clinical trials in publicly available sources (e.g. in journal articles or reports published on a register) with information in CSRs. CSRs are produced by industry as part of the licensing and authorisation process for drugs. The researchers requested these from the drug companies. They looked at patient relevant outcomes including symptom relief, side effects and mortality data and found that 86% of CSRs contained complete information about patient outcomes compared with only 39% of publicly available documents. Additionally, they found that CSRs provided considerably more information on harms.
This information is “important for the unbiased evaluation of clinical trials and for informed decision-making in health care” say the researchers and they call for all CSRs from past and future trials to be made publicly available.
Professor Carl Heneghan, Director of the Centre of Evidence-Based Medicine in Oxford said “It is becoming increasingly clear that systematic reviews that underpin healthcare interventions need to be based on full clinical study reports. The IQWIG study highlights that reviews will be systematically biased in their findings if they do not include data from full study reports. Not least because of the substantial underreporting of harms that occurs in publicly available documents.”
The European Medicines Agency wants to make all CSRs it holds publicly available with any private patient information redacted but the industry is pushing back against this. In an e-mail to Nature, reported today, Richard Bergström, the director-general of the European Federation of Pharmaceutical Industries and Associations said that industry does not agree with the EMA’s plans.
“My members are very concerned about this,” he says. “If the EMA accepts our redactions, we have no problem.” If the agency disregards the EFPIA’s concerns, however, Bergström warns that there may be a series of lawsuits against the EMA.