Earlier this year, the FDA issued new draft guidance “which aims to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of participants for whom the medical products are intended.” How will life science organizations collect and use patient input for better trials?
One key reason to focus on patients: fewer than 10% of patients enrolled in oncology clinical trials are ethnic or racial minorities, due at least in part to ethical concerns, financial and linguistic barriers, physical distance, and mistrust, according to the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Substantial barriers remain to achieving the FDA’s aim, especially regarding patient access to clinical trials that generate data required by regulatory bodies. To date, technology investments in life science research and development, including clinical studies, have increased from $17.5 billion in 2018 to $49.3 in 2022, primarily focused on automation and data analysis.
Despite those investments, the problems remain the same: site and representative patient access and enrollment problems.
“What’s needed most to solve those problems is technology centered around the stakeholders, technology that brings the more of the right people together – investigators, clinicians, patients, and industry sponsors,” said Within3 CEO Lance Hill in a recent Marcus Evans webinar. During the presentation, Hill moderated an expert panel, including:
- Jill Kearney, Global Operations Head, Oncology Early Development, Janssen Pharmaceutical Companies
- Allison Kemner, VP, Clinical Science & Operations, Tyra Biosciences
- Jennifer Lee, SVP, Clinical Operations, Biostatistics & Data Management, Elevar Therapeutics
- Jay Russak, Sr. Director of Clinical Operations, Keros Therapeutics
The panel raised and discussed pressing questions: how will the life science industry begin to achieve the aims of the latest FDA guidance? How can insights management technology support the next wave of R&D gains, especially related to patient access, investigator identification and support, clinical trial enrollment, retention, and data integrity? And how will trial sponsors identify diverse investigators who will help ensure patients have visibility into clinical trial options for new therapies?
Some experts called for a stronger focus on patient input paired with technology that removes barriers to their participation. “We need to dive in more to the patient voice,” said Janssen’s Jill Kearney. “We’ve heard from investigators who are doing our clinical research that they want a say in building protocol. Those platforms where people can go in and – in their own time – add feedback are being used by investigators and doctors, but I love the idea of getting patients involved.”
Technology – and the life science industry’s traditionally cautious approach to it – was another hot topic. “It’s going to take time for the industry to adopt this new technology,” said Jennifer Lee of Elevar Therapeutics. “It’s important to take them along with us and help them see the value that technology can have – in clinical trial design, retention, enrollment, minimizing patient burdens, and the overall quality of patients’ treatment options.”
Get all the insights from the full discussion.