Clinical Trials

Biography

Biography: Jennifer Miller

Abstract

The Good Pharma Scorecard is a reform strategy that ranks new medicines, biologics and devices and their manufacturers on key integrity indicators, beginning with clinical trial transparency. The pilot index, published in 2015, ranks the transparency of all new medicines and vaccines approved by the FDA in 2012 that were manufactured by the 20 largest companies-342 clinical trials involving 99,599 research subjects. We reviewed these trials, drugs and companies on two sets of standards: 1. The ethical standard that all clinical trials and trial results should be publicly accessible, and 2. The legal standards for trial transparency enshrined in the US Food and Drug Amendments Act (FDAAA). We considered trial information publicly accessible if the trial was registered, reported results in a trial registry, was published in the medical literature and complied with transparency laws. Up until this point, transparency practices have never before been aggregated on the drug level nor assessed by both ethics and legal standards. We found that public disclosures of clinical trial information vary widely by company. Two companies publicly disclosed all of their clinical trial results and fully complied with legal requirements, for at least one of their drugs approved in 2012. While another disclosed only 20% of trial results and scored 0% on the legal compliance index. Today, trial disclosures for new drugs fall below legal and ethics standards with wide variation in practices among drugs and their sponsors. The GPS has the potential to improve compliance with legal and ethics standards and to support data-driven decision-making.