Increasing patient engagement with UK clinical trials

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research.

Patient engagement can help address long-running industry issues, such as recruitment and retention, as well as reducing the need for additional trial protocol amendments.

As the COVID-19 pandemic heralds a major shift towards remote, virtual and hybrid clinical trial models, patient engagement is becoming even more relevant, but every country will have its own rules on how to interact with patients and their representative organisations.

In each location these regulations and codes of conduct present challenges and opportunities for companies when working together with patients as collaborators in the design and conduct of trials.

In a recent webinar from pharmaphorum, the National Institute for Health Research (NIHR) outlined why and how it has developed a new approach to engage with patients while complying with national regulations, such as those set out in the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice.

The online event also heard from Pfizer and patient advocate representatives and looked at how the NIHR’s collective approach allows life sciences firms to engage with patients while remaining aligned with ethics guidelines and codes of conduct – providing a UK solution to a global problem.

Participants agreed that the best approach is to engage with patients early in the clinical development process, preferably before protocols are finalised, in order to maximise benefits from their input and allow the clinical trial process to run smoothly.

“We need to be transparent from the very beginning about what data is going to be collected, and what's going to happen to that data.”

Involving patients in discussions

Getting patients into clinical trials has always been a huge problem for pharma in itself and seeking greater patient involvement in the actual design process requires companies to make an even more concerted effort.

According to Sophie Evett, group feasibility lead at Pfizer, the key to successful engagement with patients is to begin discussions early before the trial design is set in stone.

She told the webinar: “Speaking to patients early on when the protocol’s in the early stages of development means that protocols and other documents can be revised from the feedback.”

It also means that patient input can be used to design trial materials and supplies, such as the tote bag used to carry blister packs, for example.

Patient advocate Richard Stephens agreed and noted that while patients are unlikely to be experts in the technical details of drugs and their development, they will be able to give you valuable insight about the practical side of participating in a trial.

He said that this can be used to shape trials to make them easier for patients, with potential benefits in terms of adherence.

“During the course of my treatments and my trials, and afterwards, I was the expert in how I wanted to manage my life.”

Designing better trials

For example, Stephens said that since he was first treated for cancer more than 20 years ago, he has seen limited progress with some of the quality-of-life measures included in clinical trials.

With many patients surviving longer than five years, and the disease increasingly considered to be a long-term chronic illness, he called for a rethink of the kind of patient-recorded outcome measures used in trials.

He told the webinar: “There is still a difference between how clinical trials capture patient-reported outcomes and quality-of-life measures and what we patients are actually feeling.”

Clearly there needs to be a better way to engage with patients and there could be some real benefits in terms of the kind of drugs that are getting to market in the longer-term.

But the NIHR said there are some important implications for pharma companies who are trying to be more patient-centric in their approach to research, with more time needing to be invested up front and a requirement to be open-minded about the perspectives patients bring to the research process.

Going forward, the NIHR would like to see a more transparent and open relationship develop between all parties involved in clinical research to improve dialogue between them.

From a patient’s point of view, Stephens noted the potential of digital technology as a tool to record patient outcomes, saying that it can be used to collect feedback on a real-time basis.

Keith Wilson, a full-time patient research ambassador at Liverpool Heart and Chest Hospital Trust, said that good communication will be vitally important when using novel ways to engage patients in the research process.

He said: “We need to be transparent from the very beginning about what data is going to be collected, and what's going to happen to that data.”

Linking pharma with patients

While some patient groups are set up to work with industry, there are some who are more reticent about linking with pharma.

Gareth Powell, business development officer for the NIHR Clinical Research Network (CRN), noted that some patient groups are very happy to get involved with research projects with the pharma industry.

However, he added, others can be not so willing, for several reasons, whether it be an unwillingness to work with life science firms on principle or a lack of resource or expertise. “There's also that risk of a perceived coercion or influence. There's sometimes a bit of a barrier,” he added.

It’s important for the industry to be patient and try and establish working relationships with these organisations, by telling them about the benefits of research for society.

The webinar heard that this is where the NIHR can help, by using its UK wide network and alignment with the NHS to support industry and patients alike when they come together to support trial design.

UK solution to a global problem

As Pfizer’s Sophie Evett noted, the NIHR can act as an “independent intermediary” between pharma and patients. Working in this way can help overcome the need for lengthy contracting where resources may not otherwise exist to facilitate these and likewise, alleviates the issues of trust with the NIHR being a brand recognised by patient groups and patients.

This approach can also help to deal with troublesome issues like data protection, patients’ expenses and travel. It’s a sensitive area that must be handled effectively as at one end of the scale paying too much can be considered bribery, whereas too little risks leaving participants out of pocket and can create a barrier to involvement. By providing a transparent national framework for reimbursement and ensuring any expenses are managed up front, participants and companies can both be reassured the NIHR is managing this process.

Expertise is also required to facilitate these activities, with a knowledge and understanding of the regulatory environment, working practices of the life sciences industry and also an understanding of how patients and patient organisations prefer to communicate and collaborate.

This is just one aspect of the NIHR’s standardised, national approach to engagement activities, which has been co-designed in collaboration with patients, clinicians and companies to support engagement activities, and remove major pain points.

Pfizer was a key collaborator in this project and Evett noted that, following the NIHR’s work with Pfizer, much of the hard work has been done and a letter of agreement has been approved that is already being used as a template when working with patients.

This standardised approach ensures that the engagement activities comply with national guidance including the ABPI’s voluntary code. Companies accessing this service also benefit from the national reach of the NIHR Clinical Research Network, a huge advantage when seeking appropriate people to participate in engagement activities - especially where rare conditions are concerned.

As those taking part in the webinar noted, there has been a positive boost to the perception of industry because of the work it has done to fight the COVID-19 pandemic with novel vaccines and treatments.

It has put the sector in a strong position for the future and the NIHR stands ready to help pharma companies engage with the people their trials are intended for.

The NIHR is also embedded in the NHS, perhaps the most trusted institution in the UK. Patients are comfortable being approached by the NHS and as Pfizer’s Sophie Evett noted, this can help companies connect with patients when designing trials and getting their input.

Evett said: “Some patients might prefer to have that middleman rather than being contacted directly.

“I do think that patients and organisations are now more willing to engage through the NIHR.”