Consumer Involvement in Health and Medical Research: What’s driving change and how can health consumers contribute?

According to Research Australia, $5.9 billion is spent on health and medical research (H&MR) in Australia each year. Despite this, much research still goes unfunded. With over $1.2billion of health and medical research investment tax-payer funded, and more funding to come out of the Medical Research Future Fund, it is important that the research that is funded is both addressing the concerns of patients and the health system, and efficiently run.

Just as there has been a shift towards patient engagement in the healthcare system, the past decade has seen a growing interest in the role of health consumers (ie people engaging in the health system, as patients and carers/families of patients) in medical research. While the rest of this article will focus on consumer involvement in clinical trials as an example, health consumers can contribute across the broad spectrum of health and medical research, from basic, to applied, to health systems research.

In the case of clinical trials, worlds are colliding to drive greater consumer involvement.

In some cases, patients are funding and initiating their own research.

Leading the charge are health consumers themselves. The internet has made information more accessible. Social and patient networks provide connection to peers with the same health issues. Patients are sharing data and experiences about their symptoms and treatments, identifying areas of unmet need and unanswered questions, and advocating for research.  The phrase “nothing about us, without us” is now regularly used online, and at conferences, as patient advocates lobby for a seat at the research table. In some cases, patients are funding and initiating their own research.

Funders across the board are looking for ways to prioritise their precious research dollars, and making sure projects they support are relevant to patients is becoming key.  Many now ask how health consumers have inputted into the design and conduct of the research, and often will have consumers involved in the funding decision-making process. Sometimes this input is via a consumer representative on a review panel, or via review by a separate consumer advisory board/group.

As a result, research institutions/networks and other groups representing medical researchers such as the Australian Clinical Trials Alliance (ACTA) and the Advanced Health Research & Translation Centres (AHRTCs) have working groups actively seeking to understand best practices around consumer engagement in medical research and clinical trials, and how to support these activities.

Regulatory agencies are starting to explore patient need in deliberations about which new treatments to approve and/or fund. For example, the US Food and Drug Administration has a patient-focussed drug development initiative2, the goal of which “is to better incorporate the patient’s voice in drug development and evaluation”. The Australian Therapeutic Goods Administration also has a number of statutory committees3 making recommendations which have health consumer representation.

Due to both increasing regulatory interest in approving products that matter to patients, and the need to make clinical trials more efficient and affordable, industry too is looking to be more patient-centric. Companies are contracting patient advisory panels, seeking out patient stories, working with patient advocacy groups, simulating trial visits and more to get a better sense of the unmet needs of patients, and how to design their trials to be more participant-friendly.

Health consumers can be consulted or work in partnership with researchers throughout the entire clinical trial lifecycle from the idea and design phase, through to conduct, analysis and reporting.

Health consumer input on research priorities and questions as well as trial design and practicalities from a participant perspective may be sought via surveys, focus groups, patient advocacy groups, consumer advisory boards, consumer representatives on trial steering committees, trial visit/procedural simulations, review of participant-focussed information, and training of trial staff. Lay representatives on Human Research Ethics Committees help review, approve and monitor the conduct of trials. Patient groups can assist with trial promotion and finding volunteers, and appropriately experienced health consumers can be effective peer support for people enquiring about or participating in clinical trials. Individual consumers or consumer advisory groups may be involved in the steering committees and data safety monitoring boards that oversee the conduct of a trial. They may contribute to the analysis, interpretation and publication of trial results, help disseminate results and advocate for adoption of treatments evidenced to work.

Equally, health consumers don’t necessarily appreciate the value of their experience to research teams, nor have the training and support to work with researchers.

There are however some challenges in involving health consumer in research.

Researchers are rarely trained, supported and funded to involve consumers in their research effectively, and in many cases don’t due to lack of resources, processes or understanding about doing so5,6. While most researchers who involve consumers will speak to the benefits of doing so, the impact of consumer involvement has not been well documented and so there can still be a reluctance to invest time and resources into consumer engagement.

Equally, health consumers don’t necessarily appreciate the value of their experience to research teams, nor have the training and support to work with researchers. Setting expectations and addressing the power imbalance and language used are important enablers7,8.  For those involved in commercially sponsored research, there are sensitivities around regulatory requirements and industry codes of practice which can make meaningful consumer engagement challenging.

The Australian Medical Research and Innovation Strategy 2016-20214 acknowledges the limited degree of consumer engagement and collaboration in Australian research and the need to start to work together early in the research process. With over 1000 clinical trials starting every year, with an annual investment of $1billion+ at stake, there is considerable work to do to educate and upskill both researchers and health consumers to work together.

In conclusion, health consumers have a growing role in medical research beyond being the subjects of research, to being collaborators and partners.  Combining the expertise of patients and their carers/families holding the lived experience of a health condition, with the scientific and operational expertise of research professionals, may help health and medical research prosper, answer questions that matter to patients, and in the case of clinical trials, create a better experience for the participants involved.

Photo by Drew Hays on Unsplash