A New Collaboration to Advance Data Sharing in Clinical Research

As clinical research experts, the importance of patient-donated data. Clinical trials may be time-consuming and even burdensome for patients, many organizations are trying to make the best use of their data.

Although there is a lot of emphasis on integrating real-world data in medication research, clinical trial data is clean, vetted, and of high quality. Historical trial data, in my opinion, are the most valuable untapped resource in our sector.

Biopharmaceutical firms are beginning to respond to requests from organizations such as the World Health Organization, the National Institutes of Health, the G7, and patient advocacy groups to extensively share patient-donated data. Clinical researchers are eager to make the required adjustments, but we aren’t used to such sharing in non-competitive settings. Furthermore, we may not have the internal resources or mechanisms in place to facilitate data exchange.

To address these issues, a group of like-minded colleagues from biopharma, contract research companies, technology partners, data sharing platforms, and academic institutions formed the Clinical Research Data Sharing Alliance early this year (CRDSA). CRDSA was established as a collaborative platform for all parties to solve the logistical challenges of exchanging clinical trial data.

CRDSA will focus on data privacy, data standards, and researcher education to increase both the quantity and value of data provided for secondary research.

Consider a future in which we can enrol significantly fewer patients in control groups because we have enough secondary data to build a “synthetic” arm. Alternatively, we know ahead of time how many patients from various racial/ethnic groups we need to recruit since we used pooled trial data to predetermine the sub-groups. These future possibilities will necessitate regulatory policy improvements; we must invite regulators along for the ride to decide how synthetic or enhanced control arms can be acceptable for a registrational research. The CRDSA will establish the united, multi stakeholder voice required to effectively advocate for real policy change.

The public interest is widely regarded as being served by the responsible dissemination of clinical trial data. Data sharing maximises clinical trial participants’ contributions to scientific knowledge, helping patients now and in the future. Sharing clinical trial data can allow for the replication of research findings, analysis for different fields of study, and exploratory work to create new research concepts. While there has been progress in the effort to improve clinical trial data exchange, obstacles persist.

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