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Solving the clinical trial conundrum…

27.02.2020

Last year, we authored a white paper exploring how technology could assist with the “clinical trial conundrum” – with the number of clinical trials outpacing the pool of eligible patients, there are not enough willing patient participants to support. As we’ve continued to explore the clinical trial space over the past year, we’ve come to understand that while technology and the integration of electronic medical records (EMRs) may assist with identifying appropriate patients, it is only through the relationships forged between site staff and trial patients via face-to-face interactions that will ultimately resolve this “conundrum.” So, we wanted to understand further, how can the healthcare industry leverage the best of technology and human relationships to resolve this issue?

Taking a step back, it’s important to note why clinical trial recruitment and retention has become increasingly strained. In the oncology space, the influx of both mutation-targeting therapies (for example, MET, ROS, etc.) and pan-tumor therapies (such as IO, CAR-T, etc.) has resulted in an astronomical number of ongoing trials – each fighting for smaller numbers of a very specific types of patients. Outside of oncology, patients with chronic conditions often consider clinical trials as a last resort for treatment, if they are even thought of at all. Site staff and patients alike recognize that lack of awareness of eligibility for trials is one of the greatest barriers to recruitment – the current hope is that EMRs and other technologies will help identify all eligible patients and also encourage those patients to consider participation. This strategy may be especially important for engaging those who may not live close to the trial site or those patients who may not be actively looking for a trial.

However, identifying appropriate patients is only half the battle. The question still remains – once we find patients, how do we encourage them to consider participation? Our further exploration of the topic has revealed that the majority of patients still believe that clinical trials are for “untested medicines” and that trial participants are essentially “guinea pigs” for scientific experimentation. In direct contrast to this perception, however, are the experiences from patients who have participated in clinical trials themselves. Across the globe, clinical trial patients (both those currently on trials, and those who have recently completed a trial) have told us that the trial experience made them feel like a “VIP”– they were well taken care of, their side effects were well-managed, and they received ‘first-in-class’ care with the ‘best-in-class’ or newest available treatment option. It should also be noted that even for those who did not see clinical benefit from the trial treatment or procedure, the experience of participating in a trial was still overwhelmingly positive, and they report high levels of satisfaction at trial close.

So, this poses the question – how do we translate the experiences of those who are trial-experienced to those who are trial-naïve to discount misconceptions and encourage more frequent trial consideration and participation? We believe the answer is simple: through the face-to-face interactions with site personal. While technology can help us find patients, it doesn’t have the ability to go beyond that by overcoming the fear associated with the unknowns of joining a trial. From the perspective of the trial patients we’ve spoken with, the act of meeting the trial staff, having their specific questions answered and being educated about the treatment and what the therapy is meant to do, have all been powerful motivators to encourage them to consider participation. These conversations are not something that can be easily replicated virtually, or through a phone call – a face-to-face meeting is critically important to establish trust and mutual respect, overcoming many of the hurdles between trial awareness provided by technology and trial participation.

However, there are a few things to think about:

1. While patients are often willing to take on the cost of travel themselves (if they have the means), sponsoring companies should truly consider what they can offer in terms of travel support for potential patients and their families commuting to the trial site

2. Site staff – especially nurse coordinators – will take the burden onto themselves of ensuring they have the appropriate materials for educating their patients about the trial (i.e. creating drawings, translating language so it is understandable, etc.). Sponsoring companies can assist nurse coordinators enormously by providing the appropriate resources and tools to each site, including ensuring all materials are understandable to a newly or recently diagnosed patient. Imagine that someone is still learning about their disease, and then think, from that baseline knowledge, how can you help that patient understand what participation in a clinical trial looks like?

3. Understanding the experiences of other patients can help patients feel more comfortable – knowing the number of trial sites and number of patients enrolled, or hearing the experiences of other patients, can help ease concerns of those who are new to the trial experience

While a comprehensive tech solution to help with identifying patients may still take some time to figure out and implement, the good news is that sponsoring pharma companies do have the potential to take immediate action in solving the “conundrum” of clinical trials: equipping site staff with the support and resources they need to ensure they are able to facilitate those crucial relationships with patients, and ensure that every patient identified as eligible is able to truly consider participation in a clinical trial.

By Lisa Logan

HRW - Image of Lisa Logan

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