Authored by Kristin Croucher & David MacMurchy
Part 1 in a 2-part series. Access Part 2 here.
Taking part in a clinical trial can potentially place a considerable burden on participants and their families. People who participated in a clinical study 20 years ago, for example, would often experience immense difficulties including finding a trial, having to travel great distances for appointments, spending time away from their loved ones for long periods, and needing to take a significant amount of time off work. The reality for most people was that participating in clinical research was extremely inconvenient. For others, it was simply not possible due to multiple logistical considerations.
Today, new clinical trial models are bringing people and technology together seamlessly to reduce the burden on participants. Traditional approaches were redefined during the pandemic, accelerating the shift to telemedicine and digital health services, helping to improve comfort, convenience, and access for patients.
Clinical trials, at their core, are all about people. Firstly, and always most importantly, the focus must be on the participant. Designing a study around the needs of participants is vital for providing a better experience and can contribute directly to the overall success of the research.
New clinical trial models not only serve to significantly reduce the burden on the participant, but they can be optimised for a people-first approach that benefits their loved ones and care partners, as well as clinicians and sponsors.
Modernized clinical trials that adopt a people-first approach also have the ability to improve diversity. They can increase access by removing geographic barriers and provide participants with choice about how (and where) they take part in a clinical trial. By reducing these roadblocks, we can increase equity in clinical research by making studies available to more people from diverse backgrounds and broader geographical areas.
Building trials around the participant’s needs
To enhance the experience, it is critical that the participants and care givers voice is heard and included from the beginning, when the protocol for the clinical trial is being developed. It is imperative to help the participant balance the demands of a trial with the rest of their life as much as possible. Many of today’s models can ensure that a trial does not consume everything for those involved. Engaging the participant from the start to understand their needs is often a key ingredient to the success of the study.
One of the biggest barriers to taking part in clinical research is the financial impact it can have. A recent survey revealed that potential participants with annual household incomes below $50,000 per year are 27% less likely to participate in clinical trials.(1)
Particularly at a time when costs are rising, people who are struggling financially simply cannot wait for trial expenses to be reimbursed. The upfront expenses a participant may incur include travel to and from the study site, meals, childcare, lost time from work and other considerations. For many, the fiscal burden excludes them from taking part in a study or forces them to leave the clinical trial before it is completed.
A critical differentiator of a people-first approach is that it puts support mechanisms in place at the start. For example, providing participants with debit cards to cover any out-of-pocket expenses incurred when taking part in a trial can immediately alleviate some financial stressors.
A major consideration for a participant in a clinical trial is the opportunity to receive medications, treatments, or therapies as an alternative for their health care condition, ahead of availability in the marketplace. Another important factor is that they have the best possible experience while taking part in the trial. Participants must receive an ethical, reliable, caring, people-first experience, and that is reliant on clinical research nurses, study coordinators, and principal investigators; the entire team that works with participants must be trained to the highest standards.
We have received feedback that participants greatly appreciate it when the nurse assigned to care for them is the primary nurse throughout the schedule of assessments. It can alleviate the anxiety that some patients feel and often creates a strong connection over the course of the study.
(1) Visit: jamanetwork.com/journals/jamaoncology/fullarticle/2457394
This article originally appeared in International Clinical Trials, August 2022
Kristin Croucher, Vice President of Clinical Operations at Lightship, is a life sciences strategist with two decades of managing a range of teams and implementing high-level, multi-national operations across Africa, USA, Latin America, Europe, Asia and Australia.
David MacMurchy, CEO at Lightship, is a leader in the healthcare sector with over 25 years' experience working for leading organizations in the life sciences industry. In previous roles, he collaborated with life science companies across the US, Europe and China.