Do New Standards Make It Easier To Involve Patients In Research?

By Maya Zlatanova, cofounder, FindMeCure

“Researching and developing new, life-changing medicines is best when done collaboratively. Today’s announcement from the NIHR [National Institute for Health Research] sets out clear standards for how the pharmaceutical industry should work with patients to develop better vaccines and medicines.”

This was one the most-discussed comments from The Association of the British Pharmaceutical Industry’s (ABPI’s) Chief Executive Mike Thompson welcoming the standards during the 2017 Patient First conference organized by the Association of the British Pharmaceutical Industry (ABPI). With over 7,000 medicines currently being developed, the future of medicine looks exciting, but there are still questions: How do we achieve this future, and do we really need more standards or regulations … or more freedom?

It is a complex topic, but let’s first dive into the new standards developed by the UK’s National Institute for Health Research (NIHR) to encourage the industry to involve patients in research. Members of the public, together with representatives from the NIHR, Scotland’s Chief Scientist Office, Health and Care Research Wales, and Northern Ireland’s Public Health Agency, asked an important question 18 months ago: How do we really involve the public in research? This became a popular question thanks to the patient-centered trend. We all started speaking of the need to develop products and improve patients’ journeys by putting them in the center seeing and their health as our purpose. But the next question is: Which path do we need to take to achieve this purpose while being time- and cost-efficient?

This group of experts decided there is no one path, but there should be an example to guide different organizations and encourage more efforts in this direction. This example evolved into the new standards. The six standards are a description of what good public involvement looks like, designed to encourage self-reflection and learning. They are not designed as rules or to provide fixed ideas about public involvement in research. They support those involved in research or engagement with patients in research, such as members of the public and community groups, researchers and research organizations, and research funding agencies. By the number of organizations that applied to be some of the first to run pilots with the standards (50), there clearly is a demand for guidance on how the industry can engage with patients and use that to improve research. Undoubtably there are already many examples of studies run with the help of reference patient groups whose insights proved much more valuable than any prediction of what the best research site should look like. The good news is we are now better-equipped to experiment further with our communication with patients, so the standards are just the first step.

So, what is so special about the standards? That was the question of those who attended the two different workshops during ABPI’s event 2017 Patient First. It was the official presentation of the six standards, and many people were excited to learn how to apply them to their daily routine. Here is a short description of the six standards:

1. Inclusive Opportunities: We offer public involvement opportunities that are accessible and reach people and groups according to research needs.

2. Working Together: We work together in a way that values all contributions and builds and sustains mutually respectful and productive relationships.

3. Support And Learning: We offer and promote support and learning that builds confidence and sklls for public involvement in research.

4. Communications: We use plain language for timely, two-way, and targeted communications as part of involvement plans and activities.

5. Impact: To drive improvement, we capture and share the differences public involvement makes to research.

6. Governance: We involve the public in our governance and leadership so our decisions promote and protect the public interest.

You can access the full version here.

Contrary to what you might expect, the standards are really opening the space for reaching out to patients and finding champions who want to contribute to the studies with their own experiences. And finding doesn’t mean only going through patient organizations and using their input, but also advertising the patients’ involvement opportunities through websites and social media. Flexibility should open the doors to more people interested in research. This should come with a clear definition of what this involvement aims to achieve and a structured process both for the clinical trial team and patients before and during the study.

It is also key to have a plan for how the industry can implement feedback throughout the whole study — a “You said, we did” model of communicating. We also need to welcome the differences among patients and their journeys. At the end of the day, everything should be measured and shared with all parties involved for full transparency on what has been achieved and what is yet to be. At the same time, we all need to learn from our mistakes and create best practices, which is exactly what the standards are all about. Therefore, the NIHR has selected 10 different organizations that will be the first to try out the standards and share their outcomes. The plan is to see how the standards change their processes and results but also how easy it is to implement this level of public involvement in research.

We should all learn from the NIHR’s example, because 85 percent of people have no idea what clinical trials are, 93 percent of patients who were pre-screened for one clinical trial were never introduced to another clinical trial option, and 50 percent patient retention rate is the industry standard. FindMeCure, a platform helping people access clinical trials, and HealthUnlocked, one of the largest patient networks worldwide, have developed a white paper gathering surveys and interviews with more than 20,000 patients around the globe, sharing their opinions about clinical trials and their struggles when trying to be a part of them. There you can find more data and insights proving the industry has to do a better job planning and managing clinical trials. This white paper will be officially published soon, and I will provide access to anyone interested. And yes — clinical trials’ purpose is bringing new treatment to the market, but the real value of clinical trials for the society is to find new ways to treat people and help them live better and healthier.

About The Author:

Maya Zlatanova is a business development expert with more than 10 years of experience in the clinical research industry. She has done regulations training to some of the biggest pharma companies, as well as to the United Nations and Ministries of Health. She is a cofounder of FindMeCure, a global platform transforming the way people find, understand, and join clinical trials, and is a board member of the Patient Empowerment Initiative Committee at the Alliance for Clinical Research Excellence and Safety (ACRES).