Sponsors and CROs can improve patient centricity and boost clinical trial recruitment by developing better data-sharing practices.
According to the Good Pharma Scorecard Project, only 25% of large pharmaceutical companies are reporting clinical trial results to public databases at the prevailing industry standard. Promptly sharing study results should be common practice, so what’s the hold up?
In fact, researchers face many barriers to successful data-sharing. First, not all data from clinical trials is standardized, and may turn out to be missing crucial information. Second, disagreements persist over who owns individual patient data (IPD) and who should be granted access.
Because IPD can contain sensitive information such as past diagnoses and family medical histories, many sponsors and CROs have concerns about granting third-party access. But according to a recent survey, 93 percent of clinical trial participants support data-sharing in clinical trials. According to patient consensus, data-sharing comes with many benefits as long as best practices are followed.
Sharing Data Responsibly
While there is no silver bullet to ensure effective data-sharing, sponsors and CROs can improve transparency and patient experience by making a few adjustments to their current practices. The National Academy of Medicine compiled a list of recommendations for data-sharing, and many are changes that sponsors and CROs can adopt now.
First, clinical trial researchers should attempt to use a standardized format for data whenever possible. This ensures that other researchers can use the data to conduct further analysis. Standardizing also streamlines compliance protocols and helps clinical trials meet FDA requirements.
Second, sponsors and CROs should determine in advance what patient data can and should be shared. When managing participant-level data from clinical trials, researchers should ensure that sensitive information is de-identified, and that nothing personal is shared without consent.
Finally, the best way of addressing patient concerns about privacy is by proactively requesting consent for secondary use. Sponsors and CROs can communicate directly with patients about what types of data will be shared and how. They can also inform patients about the benefits and potential risks of data-sharing so that patients can make an educated decision.
The Benefits of Data-Sharing
Proper data-sharing practices benefit researchers, sponsors and CROs, patients, and the general public. In addition to accelerating drug development, sharing clinical trial data can increase patient recruitment by boosting interest in clinical trials.
By making data more accessible to the public, sponsors and CROs can prove their commitment to patient-centric practices. Participants in clinical trials hope to benefit from the results they generate, as well as improve the lives of future patients. Making results readily available via public databases can help the medical community personalize treatments for different patients.
Good data-sharing practices also empower patients by educating them about the potential benefits and risks involved in clinical trials. Well-informed patients are more likely to take an active role in seeking out experimental drug therapies and to adhere to their treatment regimens. These efforts complement other effective patient recruitment and engagement strategies such as social media outreach and patient support programs.
By keeping patients informed about data practices, sponsors and CROs can help guarantee that clinical trials remain a trusted treatment option among patient communities. Further, highlighting the potential of patient data to advance medical research ensures that interest and engagement in clinical trials remains high.