How Open Pharma supports responsible sharing of patient-level data for pharma-funded research

Pippa McIlwaine, Joana Osório
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13 Mar 2024

Each year, figshare, Digital Science and Springer Nature publish researchers’ perspectives on open data in The State of Open Data report. The 2023 report was accompanied by a supplement featuring data sharing case studies and commentaries from key stakeholder groups, including one from Open Pharma. Our case study – excerpts below – outlined Open Pharma’s activities in this space and considered positive actions in the pursuit of responsible and ethical sharing of patient-level data from pharma-funded research.

The landscape of data sharing in pharma research publications

Open Pharma is focused on driving positive change in the communication of pharma-sponsored research, including the communication of research data. Common data sharing concerns of pharma companies may differ from those of academic authors and institutions; patient privacy, intellectual property and data ownership are consistently highlighted as important concerns by pharma companies.

In the past decade, there has been considerable progress in data sharing in the pharma industry, with clinical trial registration and disclosure of results now mandated for many types of trials by the US National Institutes of Health and the European Medicines Agency.1,2 Most pharma companies align their policies for data sharing in publications or in registries and databases to the principles and positions developed by pharma industry bodies such as the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations.3–5 Alongside disclosing results, discussions within the Open Pharma data sharing working group indicated that pharma companies often publish their protocols and statistical analysis plans in response to journal requests.

Requests to share patient-level data are becoming more common, and this is a challenge for pharma-sponsored research, where an appropriate, ethical balance must be struck between the potential benefits of coordinated data sharing and protecting patient privacy. The use of repositories, such as Clinical Study Data Request and Vivli, that meet data sharing requirements while protecting individual privacy can help pharma companies achieve this balance.

In June 2022, Open Pharma hosted a roundtable that included representatives from publishers, pharma companies and other stakeholders interested in exploring challenges and solutions in data sharing associated with publications. As a result of the issues discussed during this roundtable, a data sharing working group for Members and Supporters of Open Pharma was established to support progress in this area.

The working group is made up of representatives from 11 pharma companies and one publisher and has been meeting regularly since July 2022. Most of the working group members hold senior roles in managing publications and communications in pharma companies, but some have senior positions in open research, data transparency and data science functions.

Open Pharma initiatives to drive progress in responsible data sharing

Open Pharma seeks to drive progress in responsible data sharing through collaboration, education, research and communication.

  • Open Pharma acts as a forum for pharma and publishing industry experts on data sharing and publications to share perceptions and experiences. These conversations have helped to address gaps in understanding between the two groups.
  • Open Pharma also seeks to promote knowledge sharing within the pharma industry. As most pharma company representatives in Open Pharma work on the communication of clinical research, the group has built a relationship with the Pistoia Alliance, a pharma industry collaboration focused mostly on research and development. The Pistoia Alliance have shared their progress on promoting and implementing FAIR (findable, accessible, interoperable and reusable) standards for pharma data.6
  • Beyond its Members and Supporters, Open Pharma works to raise awareness of the FAIR principles among everyone involved in the communication of pharma research, including pharma and medical writing professionals. The group have supported the publication of an article in Medical Writing, the journal of the European Medical Writers Association, prompting readers to think about “How FAIR are pharma publication data?”.7 The article considered how closely pharma publication data aligned with each FAIR principle and concluded that while pharma publication data cannot always be open, for legal, privacy and safety reasons, there’s an opportunity to make them FAIRer.
  • The Open Pharma data sharing working group’s first priority was to measure the degree of challenge faced by pharma and other professionals when implementing journal data sharing policies. The group developed a 10-question survey, which was also reviewed by the Global Transparency and Trends Committee of the International Society for Medical Publication Professionals. Eligible respondents included anyone involved in submitting pharma-sponsored research for publication and/or fulfilling journal data sharing requirements.8 The survey ran for 7 weeks and gathered responses from 101 participants from across the pharma and medical communications sectors. The results of this data sharing survey have been submitted for presentation at a conference and will be disseminated more broadly later in 2024.

Building understanding and commitment

Open Pharma seeks to identify opportunities for collaboration that will help to reduce barriers to responsible data sharing. It also seeks to build knowledge that supports those who want to drive change at their organizations.

For example, by bringing publishers and pharma professionals together, Open Pharma can contribute to a better understanding of the values and operating environments of these two types of stakeholders, with practical results. The results of the Open Pharma data sharing survey prompted the Taylor & Francis representatives in the data sharing working group, Matthew Cannon and Rebecca Taylor-Grant, to develop a project now approved by the International Association of Scientific, Technical and Medical Publishers (STM) Open Research Committee. The project will bring together key stakeholders from the pharma industry, publishing, academia and medical communications to propose solutions that address barriers to data sharing in the publication of health science research.

In November 2023, Open Pharma hosted a virtual summit that focused on three main topics: plain language summaries and discoverable content; open access; and data and metadata. Guest speakers for the data and metadata topic included a representative from the Pistoia Alliance talking about FAIR data, a patient who gave their perspective on the benefits of data sharing and a pharma industry member of the Open Pharma data sharing working group presenting the initial results of the data sharing survey.

The summit attendees then took part in a 1 hour-long workshop discussing several statements, including whether all health research data should be made “as open as possible, as closed as necessary”.9 At the end of this session, the attendees were asked to make a commitment related to any of the statements discussed. Commitments from pharma industry participants included raising corporate awareness of the importance and value of data sharing for the company. Publishers committed to using the results of the Open Pharma data sharing survey to improve data sharing guidance and policies. Open Pharma committed to supporting more regular communications about data sharing between the relevant stakeholders (publishers, authors, researchers and funders).

All stakeholders agreed that they have a role to play in their respective fields and committed to:

  • supporting education around the challenges that exist within data sharing and how these differ between data types and data sharing contexts
  • working towards a data sharing approach that meets the needs of all stakeholders
  • continuing to have conversations about responsible data sharing
  • exploring opportunities to overcome barriers to data sharing
  • working towards developing transparent data sharing statements.

Next steps for data sharing in Open Pharma

Open Pharma has helped publishers and pharma companies to understand their different perspectives, find common ground and make progress together. It has also committed to continuing to facilitate and support these vital conversations.

Events and discussions hosted by Open Pharma in the past year have highlighted the commitments of pharma companies to sharing research data in a responsible and ethical manner and their increasing awareness of, and alignment with, FAIR principles. Open Pharma will continue to support pharma company employees in communicating the value of responsible data sharing – which accelerates the pace of research while protecting research participants – within and beyond their organizations. We believe that these efforts will help to increase public trust in the pharma industry.

Considerations about the future of responsible data sharing for pharma research publications will need to take into account the increasing use of artificial intelligence (AI) in the medical and health science sectors. The ability of AI to triangulate information is likely to have implications for patient privacy and adhering to General Data Protection Regulation and other privacy regulations.

Immediate next steps for Open Pharma include the broad dissemination of the data sharing survey results and working with the STM Open Research Committee to promote clearer, easier and more ethical processes for data sharing during the publication of healthcare research.

Excerpts from How Open Pharma supports responsible data sharing for pharma research publications by Pippa McIlwaine and Joana Osório, a case study in From theory to practice: case studies and commentary from libraries, publishers, funders and industry by Digital Science, figshare and Springer Nature et al. (DOI: https://doi.org/10.6084/m9.figshare.25232899.v1). This work is licenced under a CC BY 4.0 licence. 

From theory to practice: case studies and commentary from libraries, publishers, funders and industry is a supplement to The State of Open Data 2023 by Digital Science, figshare and Springer Nature.

References

  1. National Library of Medicine. FDAAA 801 and the Final Rule. 2024. Available from: https://clinicaltrials.gov/policy/fdaaa-801-final-rule (Accessed 7 March 2024).
  2. European Medicines Agency. Clinical Trials Regulation. 2022. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-regulation (Accessed 7 March 2024).
  3. Joint position on the publication of clinical trial results in the scientific literature. 2017. Available from: https://www.ifpma.org/wp-content/uploads/2023/01/i2023_Joint-Position-on-Publication-of-CT-Results-in-Literature-Revised-Oct2017vF.pdf (Accessed 7 March 2024).
  4. Joint position of the disclosure of clinical trial information via clinical trial registries and databases. 2018. Available from: https://www.ifpma.org/wp-content/uploads/2023/01/i2023_Joint-Position-on-Disclosure-of-CT-Info-via-CT-Registries-Revised-Jan2018-vFINAL.pdf (Accessed 7 March 2024).
  5. Principles for responsible clinical trial data sharing: our commitment to patients and researchers. 2023. Available from: https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Report-PDFs/P-R/PhRMAEFPIAPrinciplesForResponsibleDataSharing2023.pdf (Accessed 7 March 2024).
  6. Pistoia Alliance. The FAIR Toolkit for Life Science Industry. Available from: https://fairtoolkit.pistoiaalliance.org/ (Accessed 7 March 2024).
  7. Awodiya E, Osório J. How FAIR are pharma publication data? Medical Writing 2023;31:38–43.
  8. Open Pharma. Open Pharma launches data sharing needs assessment survey. 2023. Available from: https://www.openpharma.blog/blog/news/open-pharma-launches-data-sharing-needs-assessment-survey/ (Accessed 7 March 2024).
  9. Nature Index. “A love letter to your future self”: what scientists need to know about FAIR data. 2019. Available from: https://www.nature.com/nature-index/news/what-scientists-need-to-know-about-fair-data (Accessed 7 March 2024).

Pippa McIlwaine is a Medical Writer at Oxford PharmaGenesis, where she co-leads the Open Pharma data sharing working group, including co-ordinating the analysis, communication and discussion of the data sharing survey results. She has a background in scientific research, working in both academic and industrial settings, and an interest in the communication of scientific and medical concepts.

Joana Osório is a Communications Team Leader at Oxford PharmaGenesis, where she leads the Open Pharma team to drive positive change in the communication of pharma-sponsored research in areas including open access, plain language summaries and data sharing. She has worked in the communication of science and medicine for nearly 20 years, within academic research, publishing, the charity sector and medical communications.

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