Arnold Foundation Announces $3.6M Grant to Increase Clinical Trial Transparency

Houston — The Laura and John Arnold Foundation (LJAF) today announced a $3.6 million grant to Bioethics International. The funding will allow the nonprofit group to expand its Good Pharma Scorecard, which is focused on increasing clinical trial transparency and integrity so patients can better access medicines. The first edition of the scorecard, released in 2015, ranked the 20 largest pharmaceutical companies and their new drugs based on the degree to which the companies disclosed the results of their clinical trials. LJAF’s funding will now allow Bioethics International to provide rankings for all new drugs, vaccines, biologics, and devices approved by the Food and Drug Administration (FDA). In addition, the expanded scorecard will include information about a pharmaceutical company’s willingness to disclose the clinical trial data and the trial results. The team at Bioethics International will also independently assess the reliability of the disclosures and other integrity concerns in healthcare innovation.

Clinical trials provide important insights into how well a drug works and its full range of effects and side effects. This information is essential in order for doctors and patients to make educated decisions about the best course of treatment — yet, more than a third of the clinical trials conducted in the United States and around the globe, per drug, are never fully disclosed. In fact, Bioethics International found that only two pharmaceutical companies released the results of all their clinical trials in accordance with legal and ethics standards for their drugs approved by the FDA in 2012. The organization created the Good Pharma Scorecard to address the problem and to provide patients and the medical community with thorough and reliable information about the safety and efficacy of pharmaceutical drugs.

LJAF’s support for the project is part of the Foundation’s broader Research Integrity initiative, which is working to improve the reliability and validity of scientific research by funding organizations that are promoting transparency and data sharing in the scientific process, conducting high-quality research, and facilitating replication experiments to verify the accuracy of important findings.

“When the research that supports the approval of a medicine or vaccine is available in the public domain for healthcare decision-makers to review, it benefits our entire community,” said LJAF Vice President of Research Integrity Stuart Buck. ​“Physicians can better match patients and treatments, and payers can better assess the value of new therapies. Unfortunately, not all companies and scholars adhere to the same standards of research disclosure. Bioethics International’s Good Pharma Scorecard will provide clear benchmarks for achieving higher levels of transparency and integrity for the benefit of patients.”

In total, LJAF has committed more than $17 million to efforts that promote clinical trial transparency. In addition, it has committed more than $12 million to research and pilot projects aimed at building a financially sustainable drug market that allows patients to access the medicines they need, without compromising incentives for drug development.

“To determine the value of a drug, we must know whether it is safe and effective as well as how it compares to other drugs on the market,” Bioethics International CEO and Assistant Professor at New York University School of Medicine Jennifer E. Miller explained. ​“Clinical trial transparency and integrity are critical to advancing patient and global public health as well as protecting research participants. We created the Good Pharma Scorecard to help advance these goals. The process involves setting standards, benchmarking the performance of drugs and companies against those standards, recognizing best practices, and incentivizing reform where needed. This helps drug companies, doctors, scientists, universities, payers, investors, regulators, and patient advocacy groups better ensure we have a transparent, trustworthy, and valuable healthcare innovation sector.”

The next edition of the Good Pharma Scorecard will cover all drugs sponsored by large companies approved by the FDA in 2014. Rankings for medium- and small-sized companies as well as vaccines, biologics, and devices, and information about the disclosure of clinical trial data, will be included in future updates to the scorecard, which will be released on a semiannual basis.