Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

An estimated one in five clinical trials is terminated early, up to 90 per cent fail to hit recruitment targets on time and many investigator sites struggle to enroll enough patients. These are the dispiriting metrics of pharma’s sub-optimal achievements in trials.

 

Broadening trial participation and helping ensure participants stick with a trial by lowering the patient burden is one of the keys to moving the dial on the figures above.

 

The ongoing pandemic is helping here by sharpening pharma’s focus on having efficient patient recruitment and trial processes in place to make sure they stay the course.

 

Pharma has accelerated efforts in other ways to address the issue, including relaxing eligibility criteria, simplifying consenting processes and ensuring consistent and clear communication, but something has still been missing.

 

According to Dr Anthony Yanni, senior vice president and global head of patient centricity at Astellas, pharma has never really truly understood patient expectations. “Astellas recognised this,” he says, “and set up a team to address it.”

 

The patient partnership team, which sits within the company’s patient-centricity division, has one function: to create meaningful relationships globally with patient groups. This enables research teams in the company to develop a deep understanding of the characteristics, needs and perceived value of different patient groups and then to align that with patient characteristics that physicians and caregivers are asking for. 

 

Yanni says: “At the end of the day we know that development processes have to be much more focused on the right patient, the right disease with the right characteristics so that we deliver outcomes that are connected to the patient, the provider and the caregiver. We know that delivering good science without a connection to patient need is not a satisfactory process.”

 

Forming a clearer understanding of what is clinically meaningful for the patient is already paying off, he says. “Within the first six months, we have helped research teams focus on the correct patient population, conveying a clear understanding of what a particular molecule needs to achieve, which has helped direct some of those key decisions to what we would consider to be more appropriate targets.”

 

The company has seen a noticeable reduction in patient drop-out and patient enrolment as a result.

 

Building in flexibility to trials

Marie Rosenfeld, Vice President, Head of Clinical Science at Astellas Pharma, says COVID-19 has forced everyone to consider new ways to introduce flexibility for patients taking part in clinical trials in order to make the experience far less stressful for them.

 

“Most of the industry had to pivot very quickly in terms of how we operationalise our clinical trials,” she says. “How we retain and manage our patients when they are not able to visit a physician’s office, when we are not able to get into the physician’s office. And very quickly we looked to implement different solutions that haven’t been previously available, like home health or direct patient drug shipment, or telemedicine.”

 

But remote offerings are not always seen as preferable by patients. Rosenfeld cites two recent trials conducted over the past year. “The majority of patients continued to want to visit their doctor’s office for the assessments that were key and important to them. They really valued the time they had with their physician, even though the option of having a home health nurse was available to them.”

 

When Astellas explored this further, the company found that patients wanted the flexibility to participate in trials in a way that was convenient for them, and the most meaningful for them.  “As a result of the work we have done for COVID,” says Rosenfield, “we are adapting our approach to develop solutions that can be implemented flexibly to lower the patient burden.”

 

Lowering the data burden

The experience of the pandemic has also led to a rethink of some future trial requirements, she adds. “We are really encouraging teams that are coming forward for approval of their protocols to present a thorough review of their schedule assessments, the scientific need to collect the data, or the number of visits they are having. 

 

“We are encouraging them to really think carefully, like we had to do for COVID, about what data they can live without. Is it just historically something we have collected but doesn’t really add to that patient safety or efficacy story?”

 

Lotus Mallbris, VP, Chief Development Officer, Global Clinical Development, Immunology Therapeutic Area at Eli Lilly agrees that ‘less is more’: “Historically, we have collected as much [data] as possible but now it’s about reducing the burden, not just for the patient but for the doctor as well. More often than not clinical trials are demanding data that doesn’t have any purpose for that study.”

 

Lilly is now looking to re-structure its trials to collect only the most important data in order to simplify the process for patients, save time and reduce costs to the company.

 

Mallbris also believes the more virtual approach taken during the pandemic has been an effective way to reduce the burden of time and travel for patients. “This is something which I hope continues and patients and doctors can become more comfortable with using video chats to check in.”

 

Rethinking site location

She concedes that some appointments will have to be in-person, so a flexible approach towards site location will make a difference. “Sometimes getting to a particular location is a huge burden for patients,” she says, “so we have to consider the most convenient locations for our patients, whether that be close to their home or, in the case of a paediatric patient for example, even going to their schools. These small actions can make a big difference.”

 

In a recent Lilly-sponsored COVID-19 trial, across the US, Europe and Asia, a flexible approach was adopted with sites being chosen according to where the highest rates of the virus were at any given moment. Eligibility criteria changed as the disease evolved and sites where the disease was brought under control were closed.

 

Lilly is also focusing much of its efforts on specifically reducing the burden for patients from ethnic minorities in taking part in clinical trials to ensure that all populations are able to participate. Mallbris says: “There are many measures we can take to reduce barriers that may impact the enrolment of minorities within clinical trials,” says Mallbris.

 

Trial site location is important here and this has been especially important for COVID-19 clinical trial sites as they needed to operate in cities with large populations of minorities, who are disproportionately affected by the disease.

 

Reducing the eligibility requirements can also assist trials in being more inclusive and so encouraging more diverse populations to take part, given the frequent exclusion of patients with additional conditions, an approach which can disproportionally exclude minorities, who have multiple health conditions at higher rates than the wider population.

 

Better informed consent

Ease of access to the trial content and consents that patients must engage with has also been identified as a barrier to patient recruitment and retention. If patients do not fully understand what is expected of them, they are more likely to drop out of a trial.

 

Rosenfield says Astellas embarked on a project a couple of years ago to look at the content of its informed consent form. “We did some assessments on the complexity and really had some surprising learnings around what we had previously considered patient-friendly language,” she says. “We worked to completely restructure it to ensure that the content was appropriate at a reader useability level.”

 

The company earned third place for its ‘Reimagining the Paediatric Assent Process’, at the SCOPE Participant Engagement Award, designed to inspire innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials.

 

There is no doubt that the industry has recognised that the issue of patient recruitment and retention in clinical trials and the pandemic has precipitated some of these efforts and precedents, allowing companies to innovate.

 

Evidently some of the initiatives introduced as emergency measures during the pandemic  – such as relaxations of exclusion criteria, a sharper focus on data gathering, virtual trials and flexibility of site location – look set to make it easier for more patients to participate and better medicines to result.