Bridging the gap between industry and charities: Enabling PPI in research

Public and patient involvement (PPI) in clinical research is the new normal, but bridging the gap between how industry and charities work isn’t always easy. A new guidance document is here to help.

Understanding differences and end-to-end transparency are the keys to successful collaboration between pharma and patient advocacy groups.

That’s the basis of Supporting patient and public involvement in industry-led research: Guidance for charities, which was published by the Charities Research Involvement Group in collaboration with the Health Research Charities Ireland last month.

Bec Hanley, facilitator of the Charities Research Involvement Group, said she hoped the document would support the effective development of “meaningful and productive relationships”.

“For a long time, working with industry felt too hard,” she said. “But recently there seems to have been a growing interest in involvement in this type of research – not just from an increasing number of charities, but also from more and more pharmaceutical companies.

“How can we make this type of involvement meaningful for everyone, when charities and industry come from very different starting points, and work within very different frameworks?”

The guidance, based on the experience of charities working in this area, brings together case studies and top tips in a bid to close this “how to” gap.

“It’s important to remember that you are coming from different sectors and have different viewpoints, different codes to abide by and you do not fully understand the working ways of the other.”

Strong foundations

The first step on the road to successful partnerships is laying the right foundations, says the report, which recommends charities start by developing a clear, transparent policy on how it works with industry.

“Charities and industry have different perspectives on research. Charities are working in the interests of the patients, and industry, whilst helping many patients, is profit-making. These differences need to be acknowledged in the first instance to allow transparency in any liaison,” says the report.

Non-profits need to fully understand how their supporters feel about working with industry, and be clear about which pharma activities, from R&D to patient education, they are happy to partner on.

The thorny issue of payment also needs to be tackled head on, it said.

“One of the key decisions you will need to make is whether or not to accept payment from industry for your support,” says the report, adding that there was “no right or wrong answer”.

“Whilst a partnership can raise a charity’s income and profile, it also comes with risks, including potential scrutiny from the media and/or supporters… If you are accepting payment, it is important to be clear and have an agreement from the very start about what you are being paid for.”

Practical considerations 

The guidelines acknowledge the divergent working practices of charities and industry, but also look at how these differences might be overcome.

“It’s… important to remember that you are coming from different sectors and have different viewpoints, different codes to abide by and you do not fully understand the working ways of the other,” say the authors, who recommend named PPI leads at both organisations stay in regular contact to keep projects on track and interests aligned.

It also touches on concepts such as legal agreements, code of practice compliance and fair market value – the latter of which has been the source of some confusion as the sector adapts to the expert patient era.

“When working with industry, it is now increasingly accepted that as well as fully covering expenses, it is also essential to pay for lived expertise.

“It is therefore strongly recommended that the company offers PPI contributors financial reward for their time and expertise,” says the report, adding that while there were currently no definitive guidelines on payments, companies should offer compensation “commensurate with the expertise being provided”.

“If a patient has significant expertise of their condition but also of the experience and management of the condition in many other patients, and they understand the drug development/regulatory process, then they should be seen as an ‘expert patient’ or a ‘patient opinion leader’ and the fair market value should reflect their level of expertise,” it said.

The guidelines go on to explain the strict rules around hospitality and venue choice that pharma is bound by and looks at the disparity between currently accepted ways of working and the PPI-driven future.

While paying for someone to accompany a healthcare professional to an event is prohibited, for example, the same it not true for a patient who needs a carer to help them carry out their PPI work. Charities are advised to make this clear to both the company’s project lead and PPI contributors who may need extra support in advance.

The document goes on: “You may find that you need to act as an advocate to justify this cost as an essential part of good PPI, as this may not be something that the company has done before.”

Sector-wide change

These latest guidelines are part of a sector-wide effort to provide all partners with the information they need to ensure PPI in research not only happens but actually makes a difference, said Sheuli Porkess, executive director of research, medical and innovation at the Association of the British Pharmaceutical Industry (ABPI).

“In order to make the medicines of the future meaningful, we need to partner with patients, the public and carers in how we design our clinical research.

“These perspectives are a key part of making sure that the trials patients are taking part in will give us answers about whether medicines work or not.”

The document, Sheuli added, support the ABPI’s PPI Sourcebook, which was published in June to help industry address the very same issues.