What is Patient and Public Involvement?

We defined Patient and Public Involvement as an active partnership between health professionals (e.g. regulators, doctors, pharmaceutical companies, universities) and patients and the public.

When we use the words “Patient and Public” we mean:

Clinical trial participants, patients and potential patients including disabled people, parents and guardians, people who use health and/or social care services, carers, members of the public, and the organisations who represent the interests of these individuals.

When we use the word “Involvement” we mean:

Decision-making ‘with’ or ‘by’ patients and the public, rather than ‘to’, ‘about’ or ‘for’ the patients and the public.
These definitions were adapted from Involve, a national advisory group which supports greater public involvement in National Health Service (NHS).

Why is Patient and Public Involvement important?

There are many reasons why it is desirable to engage patients and members of the public in regulatory decision-making. Healthcare policy decisions, at whatever level they are made, will ultimately affect patients' lives. Therefore patients have a moral and ethical right to play a meaningful role in developing healthcare policies. Engaging patients in health policy decision-making helps to ensure that policies reflect patient and caregiver needs, values, preferences and capabilities. The views and opinions of patients may often be different those involved in making policy decisions and therefore it is important that these views are heard and taken into account.

What is the motivation for Patient and Public Involvement in IMI PROTECT Benefit-Risk research?

Decisions about the benefit-risk balance of a treatment rely on clinical data and subjective preferences. The final decision is strongly affected by how a decision-maker values the benefits of a treatment against its risks. It is possible that these values may vary from one stakeholder to another; for example, although the balance might seem positive to one group of people with a certain disease and lead to a belief that the treatment should be authorised and be made available to patients, it might be negative to another. This means that it is important for the patient and public perspective to be represented in benefit-risk assessment.
Although there was a strong interest about how Patient and Public Involvement principles could be applied to benefit-risk assessment, we found that there were a lack of guidelines to address this topic and anticipated many challenges. As a result, we set out to investigate the concept of Patient and Public Involvement and its potential application to regulatory benefit-risk decision-making in more depth.