Recruiting for clinical trials can be challenging, In fact, one in ten cancer trials registered on between 2005 and 2011 closed prematurely due to inadequate enrolment, and many other trials took longer than anticipated to attract sufficient numbers. The reason for this seems to be a combination of pharma companies’ failure to convince people of the benefits of such undertakings, the regulatory burden and a tendency among patients to deviate from roles.

Narinder Chopra has worked in clinical operations at his current company for close to a decade, and is currently leading a feasibility, enrolment and retention optimisation team, so is perfectly placed to tackle the issue of attracting, then retaining patients for trials. It’s a knotty topic: clinical trials don’t have the best reputation, partly because companies are unable to share everything about their clinical development plans.

But as patient awareness grows and the changing nature of the industry continues apace, trial operators have to become more inventive and innovative to get their trials running properly. Number targets for enrolment must be reached if trials are to be effective. To achieve this, the challenges involved must be identified, then addressed by putting what trial operators have learned into practice.

The right direction

Chopra has had to ask many times how trial operators establish best practices to help meet projected patient recruitment timelines and allow for timely trials. “I’m a chemist by trade. I spent three years in the lab before moving to clinical research about 20 years ago,” he explains.

He has undertaken roles in clinical research and study, as well as programme and trial management roles, but over the last few years has led a recruitment, feasibility, enrolment and retention group. This focuses on the importance of early planning from a variety of perspectives to ensure that “we’re working in the right direction, and in the right locations, based on data, epidemiology and patient problems”.

Use layman’s terms. Make sure you know what’s important to potential patients and that understandable words are being used.

One of the ways the team went about this was getting post-trial patient feedback. This was designed to give a voice to those involved, and find out what went well, or wrong, to better inform future trials.

“What we’re doing is building insights from the patient’s perspective into our programme and study design to ensure that that what we do run from a study perspective is fit for purpose, and is relevant to the lives of patients and their disease experience. My team focuses on some practical tactics that address those issues.

“We are doing this is through patient engagement via advisory or focus group meetings. This means that sometimes the patients are aware of our company and the drug under investigation, and sometimes they are blinded to those things.”

One of the main ways in which Chopra and his team are looking to improve feasibility, enrolment and retention is by engaging with patients. They look at their entire experience, from diagnosis and acceptance, through to treatment and managing side-effects, always taking into account how the patient feels.

The team’s strategy is to adapt protocols to patients’ needs, rather than vice versa. This involves looking at draft trial designs and their impact on patients’ lives and deducing where pain-points might be adapted to make things easier. This ranges from simple things – coffee vouchers for the hospital canteen to make the patients feel more valued, say – through to helping to arrange more complex matters like booking train tickets, taxis or even hotels. The latter can be particularly helpful if patients are fatigued or anxious about the procedures and are grateful to have the option after a day’s participation. Another step has been to remove assessments in studies that have been deemed overly burdensome, or non-essential, while ensuring that critical endpoint assessments are retained.

Fit for purpose

The feasibility programme’s goals, Chopra explains, should (broadly) be to: assess how the purpose of a trial fits in with current standards of care; which countries currently have the capacity to run the study; and how the study fits in with patients’ day-to-day experience. “From a feasibility point of view, these have been pain points for the industry for many years, and continue to be pain points,” he says.

Feasibility often entails investigating where the pain points in a trial are, and what is causing bottlenecks. The team then tries to define these issues as accurately as possible, address them, and then extract as much data as possible about them, in order to give the best possible chance of success for future studies by learning from any errors.

“We take a step back, look at all the pieces that make up a country foundation, the country and site selection levels, and map what feeds into the different levels,” explains Chopra. “We then look at how to get the data to support the individual inputs in that decision, and where we, as an organisation, can get those; where we would get them outside of the organisation; and what database and tools we would need; and map all that out into a process.”

CROs and other outsourcing services are a means by which organisations can better understand the landscape, and how it tallies with their experience and data sources.

Aside from feasibility, there is the tricky issue of enrolment; Chopra regards social media as crucial to increasing awareness of clinical trials.

He is particularly enamoured of ‘social listening’. This is “what’s being talked about on the web and where the conversations are happening”, he explains. The virtues are a key aspect that many focus on. The idea of helping to do something good for the betterment of all, and the desire to be part of something that could lead to a cure, or a respite, and save lives. It’s a powerful emotion, and one that often gets lost, or downplayed, in trial enrolment.

Language is at the heart of a successful social media strategy. “Use layman’s terms,” Chopra urges. “Make sure you know what’s important to potential patients, and that understandable words are being used.” Other important aspects include: knowing your patients; being aware of any worries and fears; and using terminology with which they are familiar. Instead of being too instructive early on, let patients’ knowledge guide your conversations and build them up over time, while comfort and familiarity increase on both sides.

Facebook, inevitably, is central to enrolment. “Use it to your advantage in a responsible manner,” says Chopra. “It can help with disease awareness and early intervention, as well as study awareness and where a patient can go as a call to action for a clinical trial.”

Patient-led design

Chopra thinks involving patients more at trials’ design stages could yield amazing benefits in terms of accessibility and willingness to participate. “We want surveys throughout the trial to find out what is more/less burdensome, and what challenges the patients are facing,” he says. “We want to educate ourselves as an organisation about a disease’s impact. We think we know everything, but I wonder if we really understand things from the patient’s perspective. The physician’s and patient’s views can differ greatly, and we’ve had to learn to listen.”

We think we know everything, but I wonder if we really understand things from the patient’s perspective. The physician’s and patient’s views can differ greatly, and we’ve had to learn to listen.

The patient’s needs are often forgotten or under-emphasised. According to a 2016 UK study (Patients’ willingness to participate in clinical trials) led by a team from London’s Royal Marsden Hospital concluded that recruitment to clinical trials could be challenging and slower than anticipated. “Patients’ motivations for trial participation included potential personal benefit and altruistic reasons,” it said. “The majority of patients feel that participants should be informed of trial results and there is a group of patients who would like more detailed trial information.”

“Patient advocacy is key,” agrees Chopra. “The patient wants to interact with pharma and get a better dialogue.”

It’s clear pharma trials will have become a lot more patient-centric, and cross-generational, socio-economically diverse social media tools like Facebook are going to be play a crucial role in securing recruitment.

“Patients have appetite for more information and engagement,” reckons Chopra. It seems that to maintain numbers in clinical trials, more companies will have to get behind that idea.