Author: MRN
Pharmaceutical companies play a fundamental role in creating a healthier society – engaging communities through health education, supporting economic growth, and delivering disease prevention through much needed treatments. As 2024 emerged from the haze of COVID-19, the focus of how we do that and what is needed for the future started to crystallize. In 2025, Pharma’s top concerns are now shifting, focusing on minimizing Research and Development (R&D) costs, debating pricing structures for cell and gene therapies, aligning with regulatory bodies to decrease the costs that come with innovation, making therapies available in all global regions and communities, and, of course, Artificial Intelligence (AI). Further, 2025 will see the industry continuing to reinstate trust, demonstrate accountability, provide transparency, and bring appropriately costed treatments to more people, faster. The question is – how?
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- Competition. 2024 saw the stratospheric rise of GLP-1 applications, particularly in obesity and T2D. The significant competition in this area did exactly what competition should do – increase development, innovation and drive down costs. This will continue in 2025 – drawing lots of eyes to specific areas of need, which will in-turn push the industry to create the best solutions and drive down costs.
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- Initiatives focused on speed and efficiency. We all know that ‘bench to bedside’ faces many hurdles, with timelines that are long and often slip. What is needed is an efficient ‘Fast drug-to-market’ strategy, but this is not just comprised of one solution, and any claiming otherwise either a secret none of us are aware of.Rather, this strategy is a collective of initiatives – including AI in research, precision protocol development, community engagement, traditional recruitment strategies, community models (home visits, community logistics, pop up clinics), site engagement and support, and digital/consumer focused technologies. That’s a lot of pieces to fit together, and they can quickly become confusing – leading to new strategies that lack the cohesiveness required to drive process velocity and cost-effectiveness. To avoid this becoming the case, sponsors, sites, and solution providers will need transparency into how they are using these initiatives to develop their strategies, demonstrating how they will work together to reach their objectives and the impact they will have on the cost and speed of drug development.
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- Cost efficiencies. Different R&D journeys and treatments require different pricing strategies, which impact every part of the clinical trial development process. Sponsors and sites looking to work with solution providers to enhance the speed and efficiency of their trial must look to those that offer clinical research execution models that are bespoke, tailored to each drug journey and associated costs. Further solution providers need to be both clear in what their offering can support and transparent when it comes to how much it will cost – providing a clear picture on what the expected return on investment will be. This will be critical for many in 2025, especially as there has been a clear shift in pipelines towards biologics and the development of the biosimilars market. The approval of biosimilars, however, is notoriously difficult and they command a lower price on the market – which means is critical to reduce their development costs in order for companies to continue to develop these much-needed therapies.
Overall, the future clinical trial landscape will be shaped by advancements focused on making the research faster, more efficient, and more accessible to patients and sites. Patient-centric approaches to trial design and delivery will be instrumental to the success of clinical trials moving forward.
Where can community and patient-focused clinical trials deliver key impact for clinical trials in 2025?
Sponsors are reporting they now have Decentralized Clinical Trial (DCT) execution models that go beyond tech, initiatives that are embedded into clinical operations, and even specific groups focused on protocol optimization. While all types of DCTs can provide positive results for recruitment, enrollment, engagement and retention, there will never be a “silver bullet” for a clinical trial and utilizing solutions needs to be thoughtful and data driven, focused on bringing more trials to more patients, globally.
Yet there are still stumbling blocks world-over, and we are seeing this particularly with those clinical trial initiations that are not looking at how the trial can and should be integrated into the patients’ communities. Primary care and community-based delivery can be a gateway to the system for sites and patients. Taking trials out of the hospital and to pop-up clinics in the community, GP clinics, or in the patient’s home to deliver trials in a more ‘real’ patient environment will relieve pressures on hospitals and academic trial sites, generating faster trial initiations.
Supporting primary care physicians to engage with Pharma and clinical trials will create greater volume of delivery in that country and greater financial impact. Bringing trials to patients, in their own community and into their home, can improve patient enrollment and retention, giving more access and more choice to patients in where and how they want to participate. Engaging more researchers and sites in clinical trials, in communities that do not have the infrastructure, support, or experience can expand the participant pool, provide participation opportunity to underrepresented trial populations, and impact recruitment speed.
Through 2025, and well after, the industry will continue to invest in patient-centric approaches in clinical research that deliver trials efficiently. We will also see investment with increased activity in Mergers & Acquisitions, private equity resettling and confidence in the market improving. Sponsors will continue to look for faster and improved return on investment and to do this, we need to move away from the conceptual frameworks and principles of DCT, to hard data that will show the value of the solution.