Membership in Clinical Research Data Sharing Alliance enables Parexel to shape the future of clinical trial data

Parexel is the first CRO to be invited to join the Clinical Research Data Sharing Alliance (CRDSA), a year-old organization working to maximize the value of clinical data to make clinical research more productive and get life-saving medicines to patients sooner.

Comprised of representatives from pharmaceutical and biotech companies, academia, government and non-government agencies and technology organizations, CRDSA aims to make full use of clinical trial data beyond the trials where the data is originally collected, said Parexel’s Chief Digital and Data Officer Stephen Pyke, who serves on CRDSA’s Steering Committee.

Stephen recently shared some key insights from his work with CRDSA and how it supports our Data and Digital Strategy.

Why is CRDSA important to our industry and to patients? 

Patients generously give their time to participate in clinical trials and there’s an obligation for all those involved to be sure we use the data collected to the fullest extent possible. Once the data is collected for a study, we need to understand how we might further use that same data in other ways that support new studies and the testing of new drugs. This work closely aligns with Parexel’s Patients First core value.

How are we working with CRDSA to shape the future of data and data sharing?

CRDSA is focused on four workstreams, each with the potential to influence the way that we operate within Parexel and the CRO industry. Those workstreams relate to policy and advocacy, technology and innovation, secondary data use standards and data protection — with all of the work leading to recommendations for changes in the industry and standards set by regulatory agencies.

CRDSA’s focus is creating the framework and standards to ensure that when data is used beyond its primary use, it is done in a rigorous way that is accepted by regulatory agencies and ensures that the interpretation of the data can be trusted. This work has the potential to have a profound impact on Parexel, our sector, pharma companies and others with an interest in developing new therapies.

As part of our work with CRDSA, Parexel is collaborating with industry experts on a simulated clinical study using an external control arm. How will this project help identify the policy changes needed to support more data sharing?

Regulatory agencies around the world are open to the possibility of using data collected outside of a particular trial to inform the interpretation of a new study, although there isn’t a well-established consensus on how to complete it. To propose an appropriate framework of what a study with an external control arm might look like, CRDSA has developed a clinical trial simulation in collaboration with the U.S. Food and Drug Administration (FDA).

An external control arm uses existing patient data from either another clinical trial or real-world data, such as electronic medical records, as a comparator:

• What constitutes acceptable source data and what documentation is needed? Examples of data might include patient data from other trials or data from electronic health records showing how frequently similar drugs are used and what results they have.
• How to choose acceptable methodologies for selecting studies and participating patients, including how decision-making takes place and how it is documented.
• What considerations and benefits are needed in choosing analytical methods so that they are accepted by regulators and also give researchers confidence in the outcome of the analysis to make significant decisions.

From this simulation, experts from all relevant sectors can gain consensus around the best possible standard for good clinical conduct in using an external control arm or secondary data.

Stephen Pyke with the CEO of CRSDA, Aaron Mann, and another CRSDA member, Genentech, in a roundtable discussion, “Addressing Data Sharing Challenges to Drive Next-Gen Analytics” at DPharm, Sept. 13-14.

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