The Patient Experience: Transforming Clinical Trials for The Benefit of Patients

Analysis

Every pill you’ve ever taken and every therapy ever administered owes its existence to clinical trial volunteers. Through dedicated and active participation in clinical studies, these volunteers help transform therapeutic concepts into impactful treatments.

Globally, the number of clinical trials is exploding, from 5,475 in 2000 to 744,100 in 2022.[i] As we witness this massive expansion, propelled by advances in technology and an increase in collaboration, clinical trial volunteers continue to play a critical role, building the foundation for reliable and scientifically meaningful study results.

By participating, clinical trial volunteers actively contribute to medical research, enabling the discovery of innovative treatments with the aim to improve life quality of future patients. Moreover, these participants gain early access to potential new medicines, with their treatment's safety and effectiveness being meticulously monitored throughout the trial.

Yet, the journey through clinical trials has its hurdles, both for participants and researchers. Outcomes are uncertain for both parties, and ensuring adequate diversity among participants can be challenging. Volunteers might face practical issues like dedicating enough time and traveling to the study site. Emotional stress may be another significant aspect, as participating can be mentally taxing. If we don’t address these challenges, we may see fewer people participate in trials and potential delays in generating robust medical data, especially as medicines are developed for smaller patient populations. ?

Intervention

Decentralized clinical trials (DCTs) are a promising innovation for trial management. Traditionally, trials are conducted at specific hospital sites, which can be miles away for many participants. With DCTs, patients could partake at local healthcare centers, nearby laboratories, or even their own home. This is supported by tech infrastructure, including wearables and platforms for secure data sharing, alongside regulatory changes supporting DCT expansion.

DCTs mean more flexibility, less inconvenience for patients, and enhanced engagement with the process. Emotional impacts associated with a less flexible and more stressful trial experience are decreased, and diversity is improved, as patients previously excluded due to long distances to expert medical centers conducting the trials can now be involved. ?DCTs can go a long way for positive change.

At Bayer, we’re seeing the first results.

We are one of the first pharmaceutical companies to implement a 100% fully remote DCT in cardiovascular atrial fibrillation. Through this approach, we have woven in both patient and investigator perspectives even more carefully, ensuring that trial design doesn’t just accommodate but actively reflect the lifestyles and needs of participants. Investigators, too, find value in our more flexible environment, which helps them better recruit and retain participants. We are yielding results, and many investigators have expressed excitement for pushing boundaries in this new direction.

Christoph Koenen, Head of Clinical Development and Operations, Pharmaceuticals Division, Bayer, says “In cardiovascular care, DCTs are transforming how we approach clinical trials. By reducing locational hurdles and involving a diverse patient population, they have the potential to unlock a new era of therapeutic discovery.”

Our Prognosis

DCTs are the future. They deliver a reality where patients are even more involved in developing their treatment and where trial data quality is improved.

Alongside cardiovascular care, there are other therapeutic areas where DCTs have high potential, including rare diseases. Given the challenges posed by these conditions – scattered patient populations, a limited number of specialist centers, and significant patient health burdens, DCTs are emerging as a key tool, facilitating more seamless, patient-centered research and care.

While DCTs present a compelling alternative, the applicability and transition to this model across all trial types and countries require further exploration and validation. Embracing the advantages of DCTs opens up an exciting path forward for patients, pharmaceutical innovators, and healthcare systems alike. Moving away from traditional models paves the way for an alternative that offers notable benefits in efficiency, convenience, and modern applicability. The path towards broader DCT adoption requires a collective approach, where investing in digital infrastructure, adapting regulatory frameworks, and cultivating collaborative partnerships become key stepping stones. In doing so, we unlock the potential of DCTs and shape the future of clinical research.

References

[i] World Health Organization (WHO). Number of clinical trial registrations by location, disease, phase of development, age, and sex of trial participants (1999-2022). WHO Website. 2023. Available at: https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-trial-registrations-by-year-location-disease-and-phase-of-development.