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The clinical landscape is changing, particularly in oncology. This is no surprise given the new regulatory guidance, an expanding emphasis on diversity, and the financial challenges we have recently seen and will continue to see for some time to come. If you’re wondering how to navigate the changes afoot, read on to learn more about the sources of change and what the experts are predicting will be the future of modern oncology-based clinical trials.
Project Optimus et al.
It’s no secret that FDA initiatives such as Project Optimus and others continue to prompt a thorough re-evaluation of the design traditionally used for trials. This is particularly the case in early-phase oncology studies. Therefore, it’s essential that industry experts explore approaches that align with the new guidelines to optimise the design of studies and enhance their efficiency.
Diversity Matters
Another area of focus that will bring significant change to the clinical trial landscape is improving the diversity of participants. The new FDA guidance that emphasises how important diversity action plans are to address the imbalance in representation from various populations in phase 3 studies is sure to have a significant impact. Sponsors will need to consider diversity early on when planning clinical trials to ensure that everybody has similar access to new and emerging life-saving therapies. While some steps have already been made in this direction, many are far from being entirely inclusive and accessible regarding who takes part in such trials.
Patients and Site Selection
Of course, alongside the issue of ensuring diversity, patient recruitment and site selection are a vital part of clinical trials. Experts such as Dr Claudia Hesselmann of Arsenia Exploratory Medicine have emphasised how vital choosing optimal sites is when planning oncology clinical trials. Hesselmann also states that quality subjects from quality trials should be carefully identified within the early phase of trial development. Both are vital for ensuring that each trial results in robust and reliable data.
Funding Issues
Another issue that may significantly change how clinical trials progress is biotech funding, which is becoming increasingly difficult to secure. Due to increased regulatory requirements and significant economic factors, there is now a competitive landscape for those looking to secure funding. Currently, biomarker-driven trials, new biologics, novel treatment pathways, and first-in-human assets are the most sought-after projects by investors.
Patients First
No matter what changes happen within oncology-based clinical trials, the patient must remain at the heart of any clinical research project. Therefore, we must continue to educate the community about opportunities for clinical trials and address barriers that may preclude others from participating. With technological advancements and social media now available to us, it may seem that this will be the easiest part of coping with the upcoming changes. However, not everybody knows how to use these platforms. To recruit a more diverse audience, several strategies must be considered to ensure that diversity and equality in participation are a cornerstone of the clinical trial process going forward.
In conclusion, as the clinical trial landscape continues to evolve, stakeholders must keep up and adapt to new guidelines, not only to comply with regulatory requirements but also to ensure that patient-centric care and diversity are considered from the initial ideation of a new treatment right through to the clinical trial and beyond.
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