Data-Driven Planning for the Participant Burden in Clinical Trials

Current State of the Participant Experience

Participating in a clinical trial requires a commitment of one’s time and effort. This is inclusive of trial-related expenses, logistical requirements and more – but a key reason there is such burden associated with trial participation is that life does not stop simply because you are enrolled in a study. Trial participants are people with families and friends, jobs, school commitments, and all of the other daily obligations life throws our way, with the added layer of a medical condition to treat and manage.  Adding a clinical trial into the mix can be extremely demanding and complicated to navigate.

Let us look at a real-life example where a single mother with three children had one child enrolled in a study as a care option for their condition. The mother was faced with the challenge of caring for her child in the trial, getting them to the visits and enduring the expenses – all while still having to raise her other children and maintain her job to financially support the family. In this instance, the entire family is invested and impacted by the clinical trial.

These challenges have always existed for participants in clinical trials, but the burden is only increasing. Protocols are increasingly more complex, often requiring longer and more frequent visits. Fortunately, we are also seeing heightened awareness of the burden and a greater emphasis placed on understanding and improving, where possible, the participant experience. Of the assorted reasons that we’re seeing an increased push to understanding this experience more broadly, the growing support from patient advocacy groups who are playing a larger role today in study planning and ensuring the patient voice is heard is a key driver in change of thought. This coupled with the FDA’s guidance to ensure that participation of clinical research is indicative of the population who will use the medical products and address the participation of underrepresented populations has highlighted the need for robust patient support initiatives and solutions.

The Challenges of Planning for the Participant Journey

With greater consideration for the participant experience, many sponsors are already implementing innovative solutions, support options and areas of expense reimbursement to further remove barriers. But how can sponsors be sure they are introducing the right initiatives? Or covering the right costs and amounts? Though the sentiment is there, planning, budgeting, and executing the optimal participant experience can be cumbersome and disjointed.

Today, sponsors often rely on their CRO knowledge, local country teams and/or historical data and assumptions to inform participant expense reimbursement and planning. The issue is that these efforts can be highly manual, time-consuming, and reliant upon data and assumptions that are outdated. In addition to being minimal, reference data today lacks the granularity needed to make truly informed decisions – e.g., not broken down by key categories such as phase, therapeutic area, country and more.

No two studies are alike but more importantly, no two participants are alike. For example, the barriers and needs of an elderly participant in an Alzheimer’s clinical trial are vastly different from that of a teenage participant in a dermatology clinical trial. Even within the same therapeutic area, needs vary considerably. One participant may live in the city near the research center where the study is being conducted and another participant may live three hours away from the clinic. While the participant who lives further may face higher expenses related to travel, the other participant may face even greater expenses associated with childcare and logistics. These variations along with dated assumptions make it difficult to understand the actual burdens faced and support needed for specific participants in a given study.

Without data that is representative of current, real-world scenarios, costs, categories and compliance guidelines, studies can be disproportionately impacted when the planning and budgeting for participant experience is not accounted for properly. If potentially critical patient needs are not met, sponsors may experience low and slow enrollment and struggle to retain participants throughout the entirety of a trial. This can result in additional costs to the study due to extended enrollment timelines, extended feasibility assessments, amendments to adjust for patient related expenses not initially considered and overall delays in the study data deliverables.

The Future of Data-Driven Patient Support Planning

While challenges certainly exist, the industry is heading in the right direction. Step one is the acknowledgement that delivering a positive participant experience needs to be a priority in any clinical trial. As noted above, we have seen the emphasis on the patient journey grow tremendously over the past decade with sponsors, CROs and sites adopting novel solutions and introducing new initiatives at an accelerated rate.

Technology has played a significant role in driving this patient-centric approach to clinical research. It has helped to simplify the participant experience by removing certain financial, logistical, and communication-related hurdles. It has also eased site workflows by reducing or eliminating tedious administrative duties – but that’s not where innovation ends.

It’s not just about streamlining tasks, though this is also important, it’s about processing and sorting data over time to develop meaningful insights and comprehensive trend analysis. This is where there’s an incredible opportunity for growth as it relates to planning and executing the optimal participant experience.

With the ability of the industry to gain access to and leverage detailed, categorized insights by therapeutic area, region, phase, study type, travel options, etc., this will afford study teams the ability to be more informed and allow for more efficient and effective planning and budgeting for the appropriate patient experience. This includes understanding the specific costs and burdens each patient may face and therefore the most suitable solutions and services to support their journey.

The industry is on an exciting path towards data-driven insights that will enable sponsors to take their patient-centric approach to the next level, resulting in a better overall participant experience, improved enrollment and retention and more timely and cost-effective clinical trials.