Clinical trial transparency in the pharmaceutical industry is continually evolving, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Select recent and relevant stories are as follows:
The impacts of COVID-19 on clinical trial transparency and document disclosure PHUSE CTT project– PHUSE
MMS experts Barb Rusin, Senior Regulatory Compliance Manager, and Kasim McLain, Manager, Transparency recently provided their insights in a PHUSE blog examining the impacts of COVID-19 on clinical study disclosure and transparency. This blog outlines what may require immediate action.
Read the blog
Open-access data and computational resources to address COVID-19– National Institutes of Health (NIH)
The NIH Office of Data Science Strategy has compiled a list of COVID-19 open-access data and computational resources provided by federal agencies, including NIH, public consortia, and private entities. The listed resources are freely available to researchers.
View the list here
Evaluation of clinical trial data sharing policy in leading medical journals—MedRxiv
In a preprint article, researchers from the Stanford University School of Medicine evaluated if leading medical journals implemented the International Committee of Medical Journal Editors (ICMJE) data sharing statement (DSS) requirement from submissions reporting clinical trials effective July 1, 2018. The researchers found that most trials published in JAMA, Lancet, and NEJM after the ICMJE policy implementation declared their intent to make data available—despite a wide gap between declared and actual data sharing.
Read the abstract
NLM leverages data, text mining to sharpen COVID-19 research databases—GovernmentCIO
To provide scientists and researchers with COVID-19 literature and resources, the National Library of Medicine is using its database and artificial intelligence capabilities. A public-private partnership—called the COVID-19 Open Research Dataset (CORD-19)—has been formed to develop data-mining techniques to best serve the scientific community in regards to COVID-19.
Melissa Harris has the full story
Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide—BMC Medical Research Methodology
A team of researchers set out to describe the challenges of retrieving individual participant data (IPD) for an IPD meta-analysis and provide practical guidance on obtaining and managing datasets. The researchers highlighted challenges in obtaining the data, including communication with sponsors, changes in data-sharing policies, and administrative, statistical, and legal issues.
Read the article here
QUEST launches clinical trial reporting manual for universities—TranspariMED
The Berlin Institute of Health QUEST Center recently launched a clinical trial reporting manual for universities across Europe. The new manual will assist universities in making their clinical trial results public.
Read the article by Till Bruckner