The future of the clinical trial – collaboration and patient centricity

A recent webinar hosted by pharmaphorum in conjunction with INC Research delved into the question of how greater patient centricity, collaboration between stakeholders and new technology are re-shaping clinical trials.

Anyone working in clinical trials knows that recruitment and retention of patients is one of the biggest challenges of drug development.

According to the Tufts Center for the Study of Drug Development (CSDD), only 39% of sites achieve their enrolment targets, 37% fail to meet their targets and 11% fail to enrol a single subject into trials.

Finally, study timelines are frequently doubled beyond their planned enrolment periods.

One of the fundamental reasons for poor levels of patient recruitment is a lack of awareness among target patient groups. In addition to this, many of the tools currently aimed at making clinical trials more efficient focus on the needs of investigators, not on patients.

Webinar explores the keys to clinical trial success

The webinar entitled “The future of the clinical trial: collaboration and patient centricity” coincided with Clinical Trials Awareness Week and explored how partnerships and greater patient-centred thinking from the industry can help boost these levels of research participation and get effective new medicines to patients faster.

Watch INC Research’s video aimed at explaining the benefits of clinical trials to a wider audience.

The expert speakers on the webinar were Christine Phillips, Senior Director, Site and Patient Access at INC Research; Jameisha Brown, Managing Chief Equipping Officer at T3 Health and Wellness; Eric Delente, President, Patient Solutions at DrugDev; and Paulo Moreira, Vice President, Global Clinical Operations at EMD Serono and Lead, Clinical Research Awareness and Access Team at TransCelerate.

[caption id="attachment_26644" align="alignleft" width="180"] Christine Phillips, Senior Director, Site and Patient Access at INC Research[/caption]

Asked how greater participation in clinical trials is encouraged, INC Research’s Christine Phillips said the pharmaceutical industry has to build partnerships with a range of organisations, including patient representative groups.

“We have got to act as a signpost so that the patient can make an informed decision of their own,” says Phillips.

“That means we have got to change some of the things we do, or co-produce some of the solutions, in a qualitative way as well as a quantitative way.”

[caption id="attachment_26640" align="alignleft" width="180"] Jameisha Brown, Managing Chief Equipping Officer at T3 Health and Wellness[/caption]

Jameisha Brown is a patient advocate in Texas, and much of her work is based around helping the 18,000-plus members of her church in Houston with their mental, spiritual and physical health. As the Managing Chief Equipping Officer (CEO) of Health & Wellness at Windsor Village Church Family in Houston, Texas, she runs a research office from the church buildings. The organisation has over 40 academic biopharma and community research partnerships, making it one of the largest cancer centres in the world.

“I would like to challenge biopharma and research investigators to consider establishing non-traditional partnerships so that we reach racial and ethnic minorities and other traditionally under-represented groups in research,” says Brown.

[caption id="attachment_26645" align="alignleft" width="180"] Eric Delente, President, Patient Solutions at DrugDev[/caption]

Eric Delente is President of Patient Solutions at clinical trials software company DrugDev. He is an exponent of adopting new technologies to help make participating in clinical trials easier for patients.

It is often assumed that more elderly trial participants will struggle with new devices, but Delente says this shouldn’t be an automatic assumption.

“It’s important not to assume that just because of someone’s age, they are not adept at using technology,” Delente says.

“At the same time, the technology is not going to work on its own, so it requires human beings on both sides who can interact with it. I don’t think it is about replacing the human-to-human interaction, which is critical in all of these, but technology can make it much simpler, more transparent, and a lot more effective.

How can the patient voice be incorporated into the clinical development process?

“A lot of the materials and resources that are used in clinical studies seem to make the job of the research team easier, but not the experience of the patient,” says Brown. “I think if we start prioritising the patient, then maybe we would see greater adherence and participation.”

[caption id="attachment_26646" align="alignleft" width="180"] Paulo Moreira, Vice President, Global Clinical Operations at EMD Serono and Lead, Clinical Research Awareness and Access Team at TransCelerate[/caption]

In addition to his role at EMD Serono, Paulo Moreira is TransCelerate’s Lead for the Clinical Research Awareness and Access Team. TransCelerate is a collaborative initiative bringing together 18 pharmaceutical companies with the primary goal of removing obstacles that slow down the clinical research process and cause disruption to the investigative centres.  This includes removing administrative burdens and enabling sites to focus more on patients.

Moreira says patient advisory boards, focus groups, crowdsourcing and technology are all good ways of engaging with patients. “You have to be open to the feedback, and the people collecting that feedback have to be willing to be educated by the patients.”

He adds that patients are ‘starving for knowledge’ and want to know about the science and mechanism of action. Good clinical research is at the intersection of patient centricity and scientific excellence, and Moreira says we must find a way for these to co-exist. Engage early, and engage often, he advises.

“Think about the role of the caregiver and the family, be transparent, and ensure patients understand what you are committing to and not committing to. Most importantly, follow up on those commitments.”

Moreira says when working with patients, the choice of venue, logistics and other details are crucial.

“For instance, if you are engaging with patients who have head and neck cancer, the food will play a really important role in their participation. Also, involve your legal and compliance departments, and make sure they feel at ease with this collaboration.”

According to Phillips, patients frequently seek advice from their health professional, but the health professional often doesn't feel confident about passing on information about clinical trials and what they involve.

“We have an enormous responsibility to support and empower, and also to explain to patients how they can take part,” she says. “It's not just about new medicines, it's about how we diagnose a condition or a disease.”

So what role can technology play in making trials more efficient and patient friendly?

Phillips says INC Research is working with specialised vendors and partners on new patient-friendly data collection devices. One such project is with DrugDev, which gives patients their own electronic hub with access to the materials pertaining to the study in which they are taking part.

“I think developing platforms and integrations that enable us to share information and improve health literacy is going to be increasingly important,” says Phillips.

Delente agrees, saying, “We can use technology at all stages of the clinical trial process. From promoting awareness of clinical trials, to decision support tools, education, recruitment, screening tools, consent and patient engagement portals. In addition, there are now several different libraries explaining medical terms in plain language, so we can understand what a placebo is, for example.”

“It is easy to analyse the readability of a consent form these days, yet we still often see documents that require a postgraduate degree in research to be understood!”

Brown has plenty of ideas about how patients can use technology to make participation easier. “Nearly everyone has a smartphone these days, so patients could use their own phones as a journal or a diary. That would allow patients to take notes about their experience and their reactions to some types of drugs.”

Brown says this information could be uploaded to some kind of portal so that the investigator could see it before the patient comes back for their visit. “Teen patients on clinical trials like to use their phones.”

But pharma companies need to take care to consider the particular needs of different types of patients.

“I hear loud and clear that the technology is coming,” says Moreira. “But for a lot of patients, some technology is just not for them, often for very practical reasons.”

“For instance, think about patients with rheumatoid arthritis, or some other conditions where they are not able to use their fingers to scroll through an iPhone or an app.”

Instead, Moreira advises the industry to think of the concept of “fit” for the patient and design engagement in a flexible manner.

This article is based on the webinar: The future of the clinical trial – collaboration and patient centricity

To watch the webinar in full, click here (BrightTalk registration required)