Sharing data gathered during clinical trials will give us a broader understanding of the effectiveness and safety of drugs under development. Sounds obvious, right? But data sharing is a complicated process with many moving parts, involving huge amounts of information – and patient privacy, appropriate use of clinical information, and companies’ and investigators’ proprietary interests all must be considered.
Despite its complexity and risks, as Senator Elizabeth Warren wrote in The New England Journal of Medicine, “Data sharing has incredible potential to strengthen academic research, the practice of medicine, and the integrity of the clinical trial system. … [W]hen researchers have access to complete data, they can answer new questions, explore different lines of analysis, and more efficiently conduct large-scale analyses across trials.”
Data sharing has incredible potential to strengthen academic research, the practice of medicine, and the integrity of the clinical trial system.
Pharmaceutical companies have made rapid progress with their clinical trial data sharing over recent years. Many have committed to industry guiding principles that set out best practices in responsible data sharing. Technology that enables EDC clinical trials and associated data sharing standards also holds potential for increasing efficiency and lowering the costs of clinical trials. Finally, big data analytics for clinical trials also contribute to the ease of classifying and sharing important trial data.
What types of data do pharmaceutical companies share from clinical trials?
Clinical trial data shared may include:
- Patient-level data: Information collected from individual patients during a clinical trial. This can include the patients’ demographic data, genetics, baseline characteristics (demographic and disease-related), lab test results, biomarkers, levels of drug concentration, and adverse effects they experience during the trial. Sharing of this information may need to be limited to protect privacy.
- Study-level data: Data listed above that has been organized into study-level data sets through amalgamation, compilation, tabulation, stratification, etc., into tables and graphics presenting cross-patient data.
- Clinical study designs and protocols: Information and instructions given to investigators on how to conduct clinical studies, what measurements to take and how to record them, what drugs are given and when, and other protocols.
What are the benefits and risks of clinical trial data sharing?
The benefits of clinical trial data sharing are self-evident, with potential to further scientific and medical progress:
- Sharing potentially builds on current data beyond original clinical trial outcomes, leading to findings that supply patients with more comprehensive treatment options.
- Secondary analysis can lead toward improved clinical care (for example, in this study of treatments for neuropathic pain).
- Sharing data may lead others to improve the efficiency and safety of the clinical research process.
- It may reduce unnecessary duplication of work and costs of future studies.
- It provides a deeper knowledge base for regulatory decisions.
Risks of data sharing are real. For example, a clinical trial participant could suffer an increased risk of breaches of HIPAA compliance requirements or other invasions of privacy if they’re identified. Or, clinical research data gathered from a previous trial may be analyzed incorrectly — by one analysis or through multiple independent secondary studies — leading to invalid claims of health risks from a medication or other errors. Endpoints can be defined differently in different trials. Proprietary concern over data for companies and investigators is an enormous issue that’s constantly evolving.
How can clinical trial data be shared responsibly?
Carefully weigh the benefits and risks of clinical trial data sharing. Companies should measure the benefits and risks of data sharing in the same way as any component of health care, clinical research, and drug development.
Enhance sharing with legitimate researchers. Companies determine – or establish scientific review boards including impartial, non-employee HCPs and scientists – if and how data should be shared. Researchers requesting data should submit a formal proposal to:
- Present a complete description of the data requested.
- Confirm the rationale for the proposed medical research.
- Document the qualifications of the research team.
- Specify the analysis to be done.
- Document plans for publication of the clinical trial results.
- Describe any potential conflicts of interest or competitive use of the clinical trials data.
Share results with the public. Post-approval of new medication or use of an existing medication, pharma companies will submit clinical study reports (CSRs), in summary form, to the FDA, European Medicines Agency, or authorities of EU member states. Patient privacy and confidential pharmaceutical company information can be protected as necessary. Commit to sharing clinical trial results regardless of the outcome.
Share results with patients who participate in the clinical trials. Provide summaries of trial results to the people directly involved in their contribution. Many patients can now share their own data, using the power of virtual engagement platforms to interact with clinicians and researchers and make suggestions to help themselves and other patients.
Clinical trial data sharing has huge potential to change the face of drug development and public health. It’s an ever-evolving process that must be carefully worked out to avoid pitfalls. The rewards, for patients, HCPs, clinical researchers, and scientists alike, promise to be spectacular.