It has been reported that according to the Good Pharma Scorecard some big pharmaceutical companies comply with the legal requirements for disclosing results of the conducted clinical studies. However, the outcomes of many clinical trials still remain unreported.
Lately, a group of researchers has found out that many clinical reporting practices do not meet ethical and legal requirements in both academia and industry. An analysis of reporting practices by big companies between 2012 and 2014 was published in BMJ Open on the 5th of December 2017. The authors have compared the studies associated with medicines approved by FDA in 2012 and 2014.
“The good news is, for the trials that the companies conducted in patients to gain regulatory approval of their drug, [transparency levels] went up,” stated the paper co-author Jennifer Miller, a bioethicist at New York University and founder of Bioethics International, a non-profit organization dealing with ethical issues and the problem of transparency in pharmacy.
Jennifer Miller and her co-workers have created the Good Pharma Scorecard – a method of ranking of big pharmaceutical companies based on an investigation of reporting transparency of clinical trials linked to new drugs which were approved by FDA. In the latest analysis which was published in BMJ, they have investigated 505 studies linked to 19 new drugs which were sponsored by 11 big pharmaceutical companies and got FDA approval in 2014. The scientists had to look through 45 different databases including personal communications with pharmaceutical companies. They made their conclusions based on analysis of the facts whether reporting transparency complies with ethical standards (the study results should be available) and the legal standards of the 2007 FDA Amendments Act (the companies must report the outcomes of all controlled clinical studies, with the exception of phase I trials). The researchers have found out that only 67% of drug clinical investigations met FDAAA reporting requirements, and the outcomes of only 87% of clinical studies were open to the public. Though, by now these rates have improved reaching 71% and 96% respectively. However, according to Ulrich Dirnagl, a neurologist at Charité–Berlin University of Medicine, approximately 30% of all drugs approved in 2014 have been investigated in undisclosed phase II or III clinical studies which is a concerning fact.
Source: The scientist.