What is the overall problem with patient recruitment for clinical trials
In the 25 years that I have been active in the field of clinical trials, patient recruitment has been always a major challenge. More than one-third of clinical trial budgets is spent on recruitment and about one-third of the trials are ultimately cancelled due to insufficient participation. For me the most important negative consequence associated with the longstanding recruitment challenges is the time it will take for patients to have access to new treatments.
What are the key reasons for patient recruitment to be such a pain to get right? I believe it basically boils down into two major aspects:
- ^Lack of tailored and ultimately effective communication towards the patient community
- ^Failure to adequately address burden to participate for patients
The rise of decentralizing clinical trials is also reflected in digital patient recruitment tools
Decentralizing clinical trials has become one of the go-to innovations of the last decade and became immensely popular due to the Covid19 pandemic. And although decentralization is not a hype, it is certainly also not a cure for all situations.
Looking back at the two major aspects which need to be addressed in clinical trial recruitment, what could decentralization bring to the table:
- ^Opens more possibilities to increase awareness (e.g., by internet advertisements) and possibilities to join clinical trials for a more diverse population.
- ^Providing combinations of physical and remote visits should offer more flexibility for patients and their caregivers and could also offer solutions for last-minute changes due to e.g., disease developments.
The one thing however that can’t be done (yet) by digitalization in a technical sense alone is empathy towards patients and their caregivers. To quote someone that I spoke to recently working as a provider in clinical trial decentralization: “We just have to find a solution / replacement of this final step”. After which I answered: “Why should we solve that final step in a digital way – we should combine the best of both worlds instead!”
What makes or breaks (digital) patient recruitmentWhen planning (digital) patient recruitment, in my view, the following questions are crucial to carefully consider:
- ^Is your clinical trial well designed (feasible from all stakeholder perspectives, including the patients)?
- ^Is there a commitment to address patient recruitment strategies and measures as early as possible (in the design phase of the clinical trial)?
- ^Can you provide the necessary supporting infrastructure for patients to lower their burden for participation (travel / tools etc.)?
- ^Is the patient that you would like to include in the clinical trial existing and do you understand this patient’s needs?
- ^When you implement digital patient recruitment activities: how do you make sure that you reach your audience with the digital outreach measures?
- ^Do you rely solely on digital outreach, or do you combine this with continuous human interactions with KOLs, patient groups, patient influencers etc.?
- ^Are you using the right plain language for the study website and/or pre-screening tool (possibly in conjunction with health record information collection) as part of your decentralized recruitment solution?
- ^How do you assure that after pre-screening qualification patients get in touch with the study sites?
Empathic human interaction with patients and their caregivers is crucial to overcome the ‘valley-of-death’ and to boost clinical trial recruitment!
We are all aware of the existing valley-of-death in our industry for new start-up biotech companies after receiving their initial seed funding to move into their series A funding stage. I would like to make an analogy to decentralized patient recruitment. Most often, the challenge within decentralized patient recruitment is not to get sufficient potential participants reaching a study landing page, or even getting sufficient patients pre-qualified (assuming that the clinical trial as such is properly designed!), however bridging the stage of being pre-qualified towards getting screened and ultimately randomized is proven to be difficult.
If there are real human interactions available for patients and caregivers during especially this challenging stage can make or break the chances of finally arriving at the doorstep of a clinical site!
How to overcome the typical ‘Valley-of-Death’ in decentralized patient recruitment
There is no easy fix to solve patient recruitment challenges, however with a coordinated effort of combining all the available tools, including early patient engagement to optimize clinical trial design & optimize all patient-facing materials, conventional & modern outreaches, digital tools and last but not least: empathic human interaction and willingness to do this all from early on can drastically help to overcome (part of) these challenges.