Patient-Centric Clinical Trials Europe 2015

Jun 8, 2015 - Jun 9, 2015, London

Put the patient at the heart of the clinical trial

GSK Clinical Trial Questionnaire: Most Valuable Patient Initiative

A move towards greater patient centricity was behind GSK's desire to get systematic feedback from participants in clinical trials – and the company hopes its blueprint can be taken up by rivals.

Dr Stephanie Manson, GSK's Value Evidence Leader



It all started with an informal discussion with a kidney cancer patient advocate, who had taken part in a trial. She suggested that it would be nice to thank people for their participation and learn from their experience within the clinical trial. From this chance encounter stemmed GSK's Clinical Trial Patient Feedback Questionnaire, which has been shortlisted for eyeforpharma’s Barcelona Awards in the Most Valuable Patient Initiative category.

GSK's solution has been to standardize an approach to obtain patient feedback which the company hopes other manufacturers will be able to pick up and follow in their own drug development programs. Its Clinical Trial Questionnaire is designed for use – with minimal modification - across all trial types, asking patients directly what they think could be improved about their experience. The questionnaire includes questions covering everything from the beginning to the end of the trial, such as consent, convenience of the schedule, interactions with study staff and how patients receive study results.

“Everyone in industry is trying to be more patient-centric,” says Dr Stephanie Manson, GSK's Value Evidence Leader. “The problem is there is a lack of a unified approach.”

Patient-centric trials

“We have implemented a scoring of the questionnaire, which will allow us to measure how patient-centric a trial has been,” Manson explains. “We are striving to create a benchmark of patient friendliness that all studies should aspire to. At the same time, we hope to provide researchers with the feedback they need to improve their studies. By publishing and sharing this questionnaire and approach with others in pharma and the medical research community, we hope to move towards a unified solution”.

Rigorous methodology

The questionnaire development process went back to basic principles. “We looked at the literature on clinical trials and patient participation, held patient focus groups and tested the questionnaire across a range of study participants.” GSK used the same rigorous methodology as it employs to develop patient-reported outcomes and health-related quality of life questionnaires. The questionnaire was designed in conjunction with Adelphi Values, a specialist patient-reported outcomes agency.  “We had to use language that was patient-friendly, and was not full of hard-to-translate idioms,” she goes on. The latter point is particularly important, since GSK would like to see the questionnaire used worldwide in global studies. GSK also believes patients completing the questionnaire will see it as playing a useful role in gaining closure from the trial experience. “There’s an awful lot we have to learn from asking patients,” Manson insists. “After all, we’ve been using patient questionnaires to measure symptoms for years. It’s important to learn directly from the source how we can improve the trial process.”

Using results

GSK believes one of the many advantages is that the questionnaire offers companies the chance to make improvements to their trials as they go along. “Another immediate goal is to give researchers a real-time feedback mechanism,” she continues. By identifying patterns and trends in ongoing studies you could find, for example, that patient are dropping out of a study because of the study visit schedule, say, rather than having to wait til the end of a study to find that things have not worked. Likewise, it would give patients an opportunity to point out shortcomings – poor interaction with study staff, for instance,– which could be addressed as the trial goes along.

GSK plans to share the questionnaire as widely as possible both inside and outside the company to allow researchers to make as much use of it as they can. The manufacturer will also publish results and questionnaire scores from initial trials, in an attempt to benchmark its efforts.

A simple concept

And we hope to make it available to all in pharma and the wider research community without a copyright fee: GSK is giving this to the industry to help us all better understand patient feedback from research.”

The Barcelona Awards judges were impressed by the simplicity of the concept of GSK's Clinical Trial Questionnaire – which perhaps beg the question: why has pharma not done it before? Manson is candid about this. “The reason, perhaps, is a lack of motivation combined with a lack of tools,” she says. With the rise up the agenda of a patient-centric approach, this imperative to make trials more patient-focused is changing for the better.

As patients are becoming more tech savvy, the manufacturer is figuring out how to make the questionnaire not just in print format but also on smartphone or tablet. But it will not be too long before other companies can see what the fuss is about. “We’re in the process of publishing the questionnaire,” Manson concludes. “And we hope to make it available to all in pharma and the wider research community without a copyright fee: GSK is giving this to the industry to help us all better understand patient feedback from research.”

Pharma should be pleased: it will soon have a blueprint, or checklist, which should ensure that patients are heavily included in one of the key points in the drug development chain. This can only be good for everyone concerned and it is not just patients who will appreciate its value.


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Patient-Centric Clinical Trials Europe 2015

Jun 8, 2015 - Jun 9, 2015, London

Put the patient at the heart of the clinical trial

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