Development of potential or improved anti-cancer treatments may be affected by lack of transparency in data sharing between pharmaceutical companies and research groups, say experts in a new study in BMC Medicine .
The multidisciplinary team led by Flinders University researchers Mr Natansh Modi and Dr Ashley Hopkins evaluates the literature and policy developments since the 2013 data sharing commitments were agreed by US and European regulators, including the commitment to publish clinical trial results.
The agreement forged by the Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) included a commitment to give public access to clinical study reports from clinical trials submitted to the Food and Drug Administration (FDA), European Medicines Agency and EU member states.
However, the new article published in BMC Medicine identified a series of evidence-based recommendations to enhance existing principles, promote harmonized data sharing practices, and establish clearer guidelines for pharmaceutical industry data sharing.
“It will take even more commitment, time and resources to make a collective effort to enhance the accessibility and transparency of critical data in clinical trials,” says NHMRC PhD candidate Mr Modi , from the Clinical Cancer Epidemiology Lab at the Flinders University College of Medicine and Public Health.
Senior Research Fellow in Pharmacology Dr Hopkins , adds the Clinical Cancer Epidemiology Lab research is focusing on the “substantial opportunity to enhance the data sharing ecosystem” including ensuring that clinical trials deemed as eligible for sharing be made “truly accessible” and that individual-participant data (IPD) packages meet a “standard of utility”.
The BMC Medicine article is calling for maintenance of a data sharing ecosystem that prioritises science and patient-centered care, benefiting all stakeholders in the field.
Some key recommendations include:
IMMEDIATE eligibility for sharing participant-level data from any clinical trial underpinning a product label or submitted for drug approval.
PUBLIC availability of full Clinical Study Reports from all clinical trials submitted to support medicine approvals for direct download.
SHARING protocols and Statistical Analysis Plans for all published clinical trials within six months of enrolling the first participant.
PROVIDE lay summary documents to all clinical trial participants within 12 months of primary outcome completion, to comply with the European Union Clinical Trials Regulation.
DISSEMINATION of clinical trial results and result publications not dependent on clinical trial outcome or phase, covering all follow-up data.
PHARMACEUTICAL companies should have publicly available web pages detailing their data sharing policies, procedures and commitments in a standardided format.
“The proposed policy and process updates should also cover institutions such as universities, medical societies, advocacy groups, regulators, funders and journals involved in reporting and carrying out clinical trials,” Mr Modi says.
The correspondence, entitled ‘ A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies’ (2023) by Natansh D Modi, Ganessan Kichenadasse, Tammy C Hoffmann, Mark Haseloff, Jessica M Logan, Areti A Veroniki, Rebecca L Venchiarutti, Amelia K Smit, Haitham Tuffaha, Harindra Jayasekara, Arkady Manning-Bennet, Erin Morton, Ross A McKinnon, Andrew Rowland, Michael MJ Sorich, Ashley M Hopkins has been published in BMC Medicine .
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03113-0
Collaborators on the article include researchers from Bond University, University of South Australia, University of Toronto, Flinders Centre for Innovation in Cancer, The University of Sydney, The University of Queensland, The University of Melbourne, Monash University, and other clinical trial organisations.
Acknowledgements: The research was supported by author fellowships or grants from Cancer Council Australia and the National Health and Medical Research Council (NHMRC).
For more information contact :
Natansh Modi, NHMRC PhD candidate, College of Medicine and Public Health, Flinders University Mob : +61 (0)406 725 105 Email : natansh.modi@flinders.edu.au
Tania Bawden, Media Adviser, Office of Communication, Marketing and Engagement, Flinders University
Tel: +61 08 8201 5768 Mob : +61 (0)434 101 516 Email : tania.bawden@flinders.edu.au
Web: n ews .Flinders.edu.au Twitter : @FlindersUniNews
BMC Medicine
Commentary/editorial
Lab-produced tissue samples
A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies’
23-Oct-2023
A/Prof. Rowland, Prof. Sorich, and Prof. McKinnon report grants from Pfizer, outside the submitted work. The remaining authors declare that they have no competing interests.