Industry-Wide Standards to Reduce Complexity
By Elisa Cascade, Chief Product Officer, Advarra
What do I see ahead for clinical trials? Increasing clinical trial complexity will make way for the development of industry standards. A staggering 70 percent of sites say clinical trials have become more challenging to manage in the last five years, which has implications in terms of cost and timeline. One promising approach is the adoption of new, industry-wide standards that can open the door to greater connectivity and a digitized data flow. For example, use of a common protocol template can drive consistency and efficiency, reducing the time and effort needed for study design and technology set-up.
Standardization also simplifies integration between site and sponsor technology systems, enabling all users to operate in their system of choice, and data and documents to flow throughout the connected ecosystem. In 2025, clinical research stakeholders will have no choice but to come together to establish industry-wide standards and apply them consistently across all phases of research.
When it comes to the relevant technology, connectivity will prove key to overcoming the expected clinical workforce shortage in 2025. According to a recent Advarra survey of academic medical centers, non-academic care centers, and professional site/site networks, over 40 percent of sites are experiencing a principal investigator shortage, and 65 percent report a shortage of research coordinators, according to Advarra’s 2024 Workforce Development Market Survey in a report to be released in Q1 2025. The next five years are likely to remain the same as fewer than 15 percent of respondents predicted that clinical research professional resourcing will improve.
In 2025, sponsors will adopt site-centricity along with their focus on patients by finding ways to improve efficiency for sites. If not, we could jeopardize the execution of trials. Improving the technology, which has been repeatedly cited by sites as adding to their burden, will be the first step. Sponsors and CROs, as well as their technology partners, will seek to connect sites’ systems with their own systems. Connecting the site and sponsor technology ecosystem for a smooth flow of users, data, and documents will not only improve productivity, but also increase protocol compliance – a win/win for both sites and sponsors.
Elisa Cascade
Troughs and Slopes for Decentralized Trials
By Pamela Tenaerts, Chief Scientific Officer, Medable
Looking ahead, trials with decentralized elements will scale the “slope of enlightenment.” Data is emerging that show cycle times are typically beating plan timelines. When deploying decentralized elements, trials also have a lower proportion of white participants and a higher proportion of Asian participants, with other groups also showing a modest increase based on Executive Director & Professor at Tufts Center for the Study of Drug Development, Tufts University School of Medicine Ken Getz’s Keynote entitled “Examining Short and Long Term ROI from DCT Deployments” at the 2024 DPHARM annual meeting. Some have referred to this phase as the “trough of disillusionment.” In 2025, we will emerge from this.
The industry is overcoming scepticism of the decentralized trial concept with a combination of evidence and improved technology, while regulators have been removing ambiguity with clear guidance. With more regulatory clarity included in the recent release on Nov 6, 2024 from ICH E6 R3 Annex 2 , trials with decentralized elements will be deployed in a much more transparent and thoughtful way, benefiting participants with better representation, improving data, and ultimately bringing treatments to patients faster.
New drug products will also be simultaneously submitted for approval by regulators and reimbursement by payers – both of which require evidence for approval and coverage determinations. Historically, this has led to two sets of evidence generation activities satisfying the need for safety and efficacy evaluations of new medical products for regulators, but payers need to understand how a new medical product compares to available treatments to determine costs. This traditionally would take 12 to 24 months, leaving patients waiting. Approved drugs are often rejected for reimbursement because of uncertainties related to clinical evidence comparisons to available treatments, and approval trials typically test the drug in a narrower patient population. Increased use of trials with decentralized elements, and trials that include real-world data, could satisfy both regulators and payors.
Technology enables us to collect data in real time during a participant's normal day, allowing us to determine whether the treatment works in the intended population – and in the real world – while collecting data on efficacy and safety. Simultaneously, trials with decentralized elements are showing that trial populations are becoming more representative. Combining these two trials into one will eliminate up to two years of the time a patient would have to wait to buy that new medical product on the market.
Pamela Tenaerts
Hero Image Credit: Adobestock.com
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