Wednesday, 1 November, we had the privilege to be invited to be a panellist on a discussion about patient engagement in clinical trials at the Medical Technology Association of Australia’s (MTAA) annual medtech industry conference – MedTech 2017.
The discussion was chaired by Melanie Gentgall, CEO of Praxis Australia, a non-profit organisation that facilitates and fosters the exchange of ideas and sharing of knowledge, through education, training and other forums. Melanie and the panel of women Melanie had pulled together are all inspiring to us. Each in their own ways are helping patients have a greater voice, greater access to research and a pathway to contribute to improve clinical trials.
Tanya Hall, CEO and Founder of Hearts4Heart, an organisation raising awareness of the (often silent) heart condition atrial fibrillation that if left undetected can cause heart failure or stroke, spoke of the importance of research to patients and the value of disease awareness groups as a conduit for industry to engage with patients to improve their trials. To date, Hearts4Heart haven’t been involved in clinical trials, but are interested in how they could potentially become involved.
Lillian Leigh is a person living with a rare type of lung cancer that credits the clinical trial she has been a part of for the past 2.5 years for why she is still here today. Lillian graciously shared a brief history of her cancer and the journey she had to find the clinical trial she is on today. She also shared how she and other participants have lobbied for changes to the clinical trial to reduce the burden to participants. Lillian’s main calls to action for those running clinical trials were 1. to make sure trial registers were accurate, complete, and up to date to help patients find trials that might be suitable; and 2. to provide a pathway for patients to contribute to the design of trials and for participants to provide feedback to sponsors during the trial, to minimise the burden for participants as much as possible.
Dr Tina Soulis, CEO of Neuroscience Trials Australia, a not-for-profit contract research organisation specialising in neuroscience clinical research, spoke of the planning that was necessary to ensure clinical trials recruit and their own experiences in neuroscience trials.
Roslyn Ristuccia, Co-founder of ClinTrial Refer and manager of a haematology cancer clinical trials unit, spoke of the absolute necessity of having a good, up to date resource for patients and clinicians to support recruitment into clinical trials. ClinTrial Refer is a mobile smartphone app and web-based platform connecting doctors and patients to recruiting clinical trials across research networks. With the development of the first ClinTrial Refer app there was a nine-fold increase in cross-referrals between hospitals to haematology clinical trials across NSW and the ACT, and a 60 per cent increase in patient enrolments to these trials. Funding announced last week by MTPConnect will increase the capacity of the app to support recruitment to all trials nationally.
Research4Me’s founder, Dr Janelle Bowden, spoke to the reasons why industry should involve patients from the start in developing their products and clinical trials. She talked about 3 of the drivers – the environment, the business case and the practical needs.
With respect to the environment, we have payers, trial funders, regulators, healthcare providers and patients themselves increasingly turning their focus to what patients want. Due to advances in technology, patients are much better informed and connected, and are realising the power and value of their voice. Building trust with patients by taking an inclusive approach to product development and clinical trials is more likely to lead to better products that meet patients needs, better trials, and less risk patients will go off on their own and potential derailing your trials or product. Payers are looking for value and increasing turning to patients to advise them on what they value. Funders of trials are looking for greater evidence of patient input into research to ensure the relevance of research to patients. Regulators are increasingly considering the patient perspective in their regulatory decision making processes. The EMA’s involvement with patients, and FDA’s Patient Preference Initiative and Patient Engagement Advisory Committee are examples of this. In fact the EMA and FDA last year announced their intention to share best practices between each other and other agencies around how they are involving patients in their activities. Involving patients from the start of product development/clinical trials can ensure you have a solid grounding to provide evidence of the value and need for a product at the regulatory interface.
With respect to the business case, most other industries are taking a customer-centric view, yet in healthcare, it is taking most a while to get there. It makes sense to ask the people we aim to help what it is they need, want and are willing to do to improve their health condition. Getting this right is likely to lead to more successful products, that people will want to use, and pay for.
From a practical perspective, sponsors just need to get clinical trials done. You need to make sure that you are asking the right research questions, measuring the right outcomes, that the patients you think you need exist and are willing to do what you want them to do in the trial. Involving your target audience, patients, in the design and conduct of your trials is more likely to make sure you get these things right, leading to trials that recruit more quickly, complete and deliver results that have meaning to patients, but also help your clinical development decision making.
There is no one-size-fits-all patient engagement approach to every trial, product, company, or therapeutic area, and so it is something companies will need to tailor. For those looking for assistance, there are collaborative groups working on guidance about how to approach public involvement in trials, such as the Clinical Trials Transformation Initiative’s (CTTI) Patient Groups project.
Research4Me aims to provide a platform to support the public, patient groups, triallists and industry to get the support they need to get involved, share experiences and work together on clinical trials. If you are interested in discussing how we might help you, please get in touch. We’re also sure each of the above panellists would also be equally delighted to answer any questions you have about their activities and their aspirations for increasing patient involvement in clinical trials.