There has been growing interest in implementation of pragmatic approaches in clinical trials. Especially for enhancement cancer research conduct including regulatory communications and ultimately patient care, where the use of Pragmatic clinical trials (PCTs) model turned out to be highly effective.
By adopting PCTs model, companies might consider gradually using hybrid approach, which means integrating new methodology into traditional one. This is an approach which is recommended to enhance clinical research. The new model can help further to streamline the research processes, enhance generating quality data, ease population involvement while expand participants’ diversity. Because of these positive effects, ‘hybrid PCT’ model balances better application of real-world data and at the same time, scientific processes in context of more reliable research outcome. The model offers more streamlined approach that can help significantly regulators to review more efficiently and faster regulatory submissions including new applications. One of the most important benefits is, that it can speed up the processes making new effective therapies available sooner. This is very important factor in the current environment of limited cancer treatment options. This hybrid PCT model can also positively reflect on cost effectiveness of clinical research, which at the present economic climate it should also be very attractive element to be well considered and therefore appropriately implemented.
In light of more modernising clinical trials conduct approaches, this model has been piloted in a big multicentred Phase 3 non-small cell lung cancer study (the trial treatment supplied by Merck and Eli Lilly and Co.), named ‘Pragmatica-Lung’. The trial took only 7 months from study set-up, making it available in more than 500 sites across the Clinical Trials Network. The study design cut extra tests and made the eligibility more flexible to allow more diverse patient population. If conducted in usual fashion, big studies like this one, could be a costly project and logistically quite complex. This model has proved the opposite and therefore it should be further considered and developed in light of improving future oncological drug discovery processes and overall research infrastructure.
The PCTs model offers great reduction in overall trial complexity while delivering positive effect in the following factors:
- Lower research cost by reducing required assessments
- Facilitated regulatory review outcomes
- Reduced operational complexity
- Accelerated study start-up
- Better use of real-world data
- Smoother integration into standard of care medicine
- More diverse patients’ population by expanding eligibility criteria
- Improved commercial sponsors & collaborators engagement
- Enhanced number of new sites involvement
- Better platform for statistical analysis
Conducting cancer studies still continue to be ongoing challenge where we should remain in good focus how to keep improving and optimising the effects of studies conduct concentrating on:
- How further can we expand patient inclusion criteria in order to mimic actual patients’ population diversity
- More focused patient relevant outcomes
- Including more technological advancements (AI, data science) that can assist us more effectively to work with the real-world data and evidence
- Smoother collaborations and new agreements among stakeholders on high quality data delivery and results implementation.
Conclusion
Integration of PCTs model should be applied where possible, also in non-cancer clinical trials. This will deliver suggested advancements, better platform working more efficiently on patient-centred drug developments processes while overall moving forward within more effective and efficient strategies.
Resource
https://www.esmorwd.org/article/S2949-8201(24)00043-2/fulltext
Author: Galina Fujimori Petrikova
Published: 19 Sep 2024
