Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

Clinical trial recruitment is a perennial challenge for pharma. Are they listening to patients?

By Adam Chapman on Jul 27, 2018

If echo chambers, polarizing politics and solipsism sums up the world in 2018, the art of listening has become gold dust.

The pharma industry appears to be bucking the trend however. When it comes to the patient voice, companies are becoming all ears, with patient insights driving internal decisions across the board.

We decided to put this proposition to the test.

One of pharma’s perennial thorns is clinical trial recruitment. 86% of clinical trials do not reach recruitment targets within their specified time periods. Patients clearly have their grievances but are pharma companies truly listening? More importantly, are they doing something about it?

We enlisted Dominique Hamerlijnck, EUPATI fellow and lung health advocate, to outline five reasons why pharma companies struggle to recruit patients, and then put it to Katie Mazuk, Senior Director, Global Head Investigator and Patient Engagement, Janssen.

1. Come again?
Most patients are quite willing to engage in clinical trials, but the information given in consent forms can be very confusing, says Hamerlijnck.

“On average they are way too long and quite often they are not written at a level of language that is understandable for many patients — not all patients are health literate.”

One solution she proposes is to employ specialists to give the information not only in a written format but break the information down into bite sized videos, using language that is is less technical and more patient-friendly; like a news segment on the website. 

This would be a simple and relatively inexpensive way to engage with patients, who could watch and rewatch the segment with their friends and family for further clarification. “It can be hard to grasp the essence of the information, this would make sure informed consent is genuinely informed,” she says. 

Pharma’s response:
Informed consent remains a significant challenge for the pharma industry, says Mazuk. To address the issue, Janssen worked with patients to create a more patient-friendly informed consent. After going through several iterations with patient focus groups and health literacy experts, the co-created informed consent has now been rolled out across all clinical trials. 

The experience was instructive, she says. “What was interesting was that everybody internally thought the goal was to reduce it to the least number of pages but what we learned from working with patients was that it is not about the number of pages, it is about how you present the content, the words you use, how you visualize it.”

Janssen are also using multi-media channels to support the consent process (videos, e-learning, etc.) to optimize the ways people like to receive information today, says Mazuk.

2. Too little too late
Hamerlijnck stresses the importance of involving patient advisory groups from the moment you are first thinking about a drug. Reaching out when you are setting up the clinical trial is too late. Considering the patient perspective from the get-go will forge greater trust, will make the clinical trial more relevant to the patient experience and will ultimately speed up the process.   

“We might not have anything relevant or world shocking to say in the beginning, but trust will emerge, and we will understand each other, and this will create the basis for in depth discussions,” she says.

It is about feeling valued, she says. “They [pharma] have a drug that is supposed to do X, Y, Z and they want to see what it does in the patient with disease E, but there is a person who has a disease and they are missing the context; the knowledge of living with a disease that a patient can bring to their knowledge base. We bring a completely different perspective — this requires a mindset change. Patient relevant outcomes need to be included in trial outcome measures.”

Pharma’s response:
Janssen has made early and often engagement its ethos, says Mazuk. “We believe it spans from research and development all the way through to commercialization.

On the R&D side, we are not just communicating after clinical trials have been designed but very early on, as we are developing our compound development strategies and our disease area strategies — we need to know from patients what matters most in the development of our compound, so we fully agree with as early and often engagement.” 

Mazuk acknowledges that historically a broad divide existed between advancing the science and working around the technical constraints and delivering on what patients want. But this way of thinking has radically changed. 

“We all have different points of view on things but bringing together a diversity of views actually makes solutions and products that are stronger and meet patient needs better at the end, so it was sort of recognizing that if you engage early and often you end up with a better product at the end.”

How does Janssen measure the success of its early and often mantra? “In our business process we have many deliverables that are part of the compound development life cycle and so what we have done is create a dashboard where we routinely measure the compound and go to the team and basically confirm that patients were involved in the development of those deliverables. It includes documents around our compound development strategies, our product development strategies, as well as clinical trial design too.” 

Mazuk has found regulators to be very supportive of the patient voice in the design space. “At the end of the day you have to balance all of the stakeholders needs when you finalize a clinical trial. It is very powerful to hear that they [regulators] are open and receptive because ultimately it is the patients that they serve too.”         

3. Out of the loop                                  
Feeding back to patients, letting them know how far along they are and reconnecting with them when the trial is done would make them feel that their contribution and involvement was valued, even if the drug proved ineffective for them , says Hamerlijnck.

It would help change a patient’s perception. They are often only viewed through a purely mechanistic lens, she says. “You may have set up the trial according to all the safety regulations but as research subjects for a clinical trial, we allow you to put our lives at risk, we give you an enormous amount of power over our health.”

Explaining to a patient why you are asking them to do certain tasks (like questionnaires, diaries, physical tests, hospital visits etc.) could also motivate them to do the best job they can and would stop them feeling that they need to do a lot of things that serve no purpose. 

And make sure you ask them to do only things that are relevant for the trial and that add to the data needed. Often research subjects are asked to fill out a diary. Filling out a diary is a tedious , time-consuming and invasive task, with little understanding of how it impacts the end-results of the trial and what will be done with the data, she says.    

“Is it really essential and why are you asking them to do it?”

Pharma’s response:
Mazuk agrees feedback is fundamental, irrespective of the outcome. When finalizing a trial design, a patient’s contribution might be deemed unworkable in the eyes of regulators. In this instance, Janssen will close the loop back with the patient that has helped them in the design process and clearly say: ‘We heard you and we brought it in, but here is where it landed with the regulatory authorities and why’.

She recognizes the importance of keeping patients in the loop, whether it be at the design stage, throughout the trial itself or even at the recruitment stage. “If we can proactively equip our clinical trial sites and our investigators with the resources to explain why the trials are designed a certain way and for what reasons, all of that communication ensures everybody is informed about how we are shaping trials together.” 

4. Carers count  
Coordinating with patients carers could boost clinical trial recruitment, saysHamerlijnck. “In some diseases it is essential to include the informal carers because they are the ones that have to explain what is going to happen, bring them to the hospital and combine this activity with their everyday life.”

For some patients, this could be a make or break. “I have read research proposals where they have wanted the patient to go the hospital every week for tests and I said, 'Sorry but that is never going to happen. You are never going to recruit anyone in this trial because this is completely impossible.'”

Pharma’s response:
For Janssen, the ongoing bid to better understand the patient journey within specific disease areas has made this a top priority.

“There are certain disease areas like early Alzheimer's or pediatric diseases where the caregiver is not only a big part of the patient’s life but is critical to the success of the clinical trial and the patients experience in the clinical trial,” says Mazuk.

The company has made a concerted effort to coordinate with carers to understand not only the needs of the patient, but also the carers needs. The exercise has been eye-opening for Janssen. “The needs can be very different between the patient and caregiver and both have to be addressed.”

5. Unrealistic expectations
Most people with severe diseases have a limited amount of energy. Travelling to a hospital can be exhausting for patients, let alone having to contend with physical tests and questionnaires when they get there, says Hamerlijnck.

Pharma companies should find ways to facilitate remote testing where possible, she says. “Is there an option to send a car around to take a blood sample at a patient's home or whatever other measurement you need to take?”

When there is no way around it, companies should give patients ample time to recuperate after making the journey. The resting time between tests should also be carefully considered. These insights will not come from “higher science” says Hamerlijnck; reiterating the need to consult patient advisory groups as early as possible. 

Pharma’s response:
How to make clinical trials less burdensome for patients remains a core challenge for the industry, but Mazuk is encouraged by the pace of technological innovation. “We are really trying to push the envelope with virtual trials, figuring out what we can do locally versus centrally.”

Success will hinge largely on collaboration, she says. “We have got to partner with patients, regulators, sponsor companies and doctors on this because the bar is so high about the quality and integrity of data and patient privacy.”

It should be an easy sell. Creating a clinical trial that fits a patient’s life, making it easier for them to participate in and stay on for the duration, will get innovative drugs to market quicker. The benefit this would bring to healthcare systems and wider societies is writ large.