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Hello. I'm Allan Hackshaw and I'm going to give a brief overview about the patient and public involvement features of clinical trials.
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In previous sessions, I talked about how trials are designed and analyzed. How they're conducted, and the ethical and regulatory considerations. But here I'm going to give a very brief outline of how patients or participants can be involved in the studies. This is a key feature of modern clinical trials now there's enough patient or public involvement. I'm going to give an outline of why it's useful and how it can be done.
0:37
What is patient and public involvement? For many decades, clinical trial concepts and designs were just developed by a group of health professionals or clinicians on a topic they thought was most important for society or for patients. But over the last several years now, the involvement of patients or public participants is much more integrated and they can be incredibly useful not only in terms of designing a study but also trial conduct. It could involve members of the general public that represent the target trial group, i.e., people with a particular disorder. It could be current or past patients with a disorder of interests, carers, patient advocacy groups or charities that represent people with that disorder of interests. There's all sorts of sources that we can get these people from.
1:27
Why is PPI useful? They can be incredibly helpful in terms of comments on whether the new intervention is going to be appealing to them. It's not uncommon that a group of health professionals think that new intervention is going to be appealing to patients and when they try it out, actually, isn't. Knowing that upfront helps hugely with delivering the study or even adapting intervention accordingly. PPI input can help the trial design so they can say if there are too many extra clinic visits or assessments or if being involved in the trial costs them too much money because they have to attend the centre. They can help to create the participant information sheet materials and how it's worded and they can help solve problems with trial conduct such as low recruitment. They can help interpret the trial findings at the end in a simple way that can be sent to all trial participants and to disseminate the information. Many funders of trials now want to see significant PPI input as part of the grant application because they want to see integral involvement between the PPI members and the health professionals. An extension of PPIE

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