Yale-developed scorecard promotes better clinical trial data sharing

July 10, 2019

New Haven, Conn. -- A tool developed by researchers at Yale, Stanford, and Bioethics International can promote greater sharing of clinical trial data by pharmaceutical companies. While nearly one-third of the companies that the researchers assessed met standards for sharing data, others could be more transparent to the benefit of science and the public, the researchers said.

Their study was published in The BMJ (British Medical Journal).

Since the late 1990s, new laws and regulations have increased requirements for pharmaceutical companies to register and report results from clinical trials. Yet, some companies don't fully comply, and industry guidelines vary. To assess the data-sharing practices of large companies, lead author Jennifer Miller and her collaborators developed a new tool consisting of a set of standards and a ranking system.

The researchers applied the tool to large pharmaceutical companies with drugs approved by the FDA in 2015. Initially, the investigators found that 25% of companies fully met their standards. Those standards included registering clinical trials, sharing data and study protocols publicly, and reporting requests for data on an annual basis.

When given the opportunity to improve their score, a few companies responded, and the proportion of those meeting the standard rose to 33%. They did so by updating their policies to report annually or by adding timelines for data sharing, the researchers said.

"The findings show that this scorecard and ranking system work," said Miller. "It's one tool we can use to set standards and catalyze change in the industry."

However, the study also found that some companies could go much further to share trial data in a timely and transparent way.

Data sharing has many benefits, the researchers noted, including generating knowledge, promoting evidence-based guidelines, and maximizing use of data.

"Data sharing is important for advancing development of new cures and therapies," Miller noted.

The next step for the team is to make annual assessments of companies' data-sharing and transparency performance, and to expand the scorecard to address drug pricing and clinical trial design practices, said Miller.
-end-
Other study authors are Joseph S. Ross, M.D. of Yale, Marc Wilenzick, and Michelle M. Mello. This work was conducted as part of the Good Pharma Scorecard, at Bioethics International, supported by a grant from Arnold Ventures. Authors' competing interests are detailed in The BMJ.

The dataset for this study will be made available on Bioethics International's website for the Good Pharma Scorecard.

Citation: The BMJ Contact: Ziba Kashef 203-436-9317 or ziba.kashef@yale.edu

Yale University

Related Clinical Trials Articles from Brightsurf:

Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic
A significant portion of cancer patients may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic.

COVID-19 clinical trials lack diversity
Despite disproportionately higher rates of COVID-19 infection, hospitalization and death among people of color, minority groups are significantly underrepresented in COVID-19 clinical trials.

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.

Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.

Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.

Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.

Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.

When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.

New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.

Read More: Clinical Trials News and Clinical Trials Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.