December 8, 2022
Why We Need a Data Sharing Revolution in Clinical Trials
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Hannah Lippitt
Recently I had the privilege of interviewing Data Scientist Aaron Mann for the Totally Clinical podcast. Aaron is CEO and co-founder of the Clinical Research Data Sharing Alliance (CRDSA) with decades of experience working in data science, including as Roche and Genentech’s global program lead for industry collaborations data sharing initiatives.
During our conversation, Aaron explained how the CRDSA came into existence due to his frustration at the lack of industry action with secondary-use data in clinical research. Uniting the clinical research ecosystem with one voice is important to improve sharing and reuse of clinical research data and accelerate drug discovery. Recently, the CRDSA’s Technology and Innovation Work Group announced that its data-sharing technology assessment framework is now available, so I thought this presented a great opportunity to reflect on some of the discussion points Aaron and I touched on during our conversation.
The Role of Key Stakeholders
One issue Aaron highlighted during the podcast is the important role major stakeholders play in facilitating the use of clinical research data downstream. In Aaron’s own words: "The question that CRDSA is really involved with is, 'What happens after the trial? How do we reuse those patients' data?'" With so many stories of data leaks flying around in the media and privacy concerns at an all-time high, I felt it fitting to ask how companies can assure patients that allowing access to their data is safe and worthwhile. Aaron emphasized that patients join the trials in the first place to further science and are happy to have their data used to that effect. The real issue lies with how to responsibly share that data for secondary use. For sponsors it can be tricky getting the balance right to protect patient data and still ensure high data utility. This is where the CRDSA comes in, by having the industry come together on what "good" looks like from both perspectives.
Sites also have their key role to play. Even though sharing data for secondary use is downstream from the daily pressures sites have to deal with, there’s the opportunity to connect with patients at the recruitment stage to discuss why participating in clinical trials is important. By helping patients to understand how valuable their data is and how it is going to be responsibly reused to further the science, concerns about data and privacy can be addressed.
Rethinking Trial Design
Improved trial design is another benefit of collecting and reusing data. If we don't reuse data – if it sits behind gates and locks – then the opportunity is missed to design better trials. Aaron explained: "If we have patients today that are approved in a clinical trial, the indication or the compound is approved and it becomes the standard of care – why can't we reuse that trial data in the next trial and reduce the number of patients to recruit? Or reduce the number of patients randomized to the control arm and have more patients on the investigative product?"
As an industry and as an ecosystem, patient recruitment is difficult – yet data is available that can help minimize the burden on patients and increase the ability to have trials ramp up more quickly and run more efficiently. The CRDSA is actively working with regulators like the Food and Drug Administration (FDA) on key questions: What are the guardrails for creating a supplemental control and reducing the concurrent control population? What does good data even look like? What are good selection practices? By working together with regulators, stakeholders can figure out the best way to proceed.
Throughout my conversation with Aaron, I was struck by how little is understood outside of the industry about the incredible advantages for humanity in sharing clinical research data. The scary headlines about leaks can increase resistance and lower trust among the public, but as Aaron pointed out, these stories tend to be in other industries and not in clinical research where data collection is highly secure. This is where better education can play a role and industry stakeholders can help to enable this in their conversations with patients at the recruitment stage. We have the tools to understand these big datasets. We have the methods to protect patient privacy, so they feel safe. As Aaron puts it: "We as patients, as consumers, we own that data."
For more about the work CRDSA is doing to help organizations advance external data sharing or internal data reuse capabilities, you can download the Introduction and Implementation Guide and Excel Framework