Janssen recently provided updates about its Investigator and Patient Engagement (I&PE) initiative, including Better Trials. Made Together, which launched last year.
To learn more, Outsourcing-Pharma (OSP) caught up with Maura Snyder (MS), director of patient engagement strategy, Janssen, who spoke last month at eyeforpharma’s Patient Summit USA.
OSP: Why is increasing our ability to amplify patient and investigator voices in clinical trials so important?
MS: The patient and investigator voice is critical to ensuring that the clinical trial is relevant and meaningful, from both the protocol and operational perspective.
Do the protocol endpoints matter? Does the time and event schedule work for the site and patients – is it actually do-able? Are the solutions that we are looking to implement to support sites and patients actually helpful and creating a better experience?
At Janssen, we have shifted our focus from doing things for patients and investigators to doing things with them.
OSP: What are the biggest challenges to getting patients and investigators more engaged in clinical trials, both during the trial itself and afterward?
MS: The biggest obstacles to getting patients more engaged in clinical trials is the need to raise awareness of clinical trials and demystify assumptions of what a clinical trial is. Once in a trial and afterward, engaging patients and making them feel part of it (as opposed to just a participant) is critical to patients being invested for the duration and beyond.
For our investigators and site staff, the amount of responsibilities and administrative burden can be overwhelming. At Janssen, we are continuing to keep this top of mind and identify solutions to make the experience as easy as possible. This is imperative because without investigators, site staff and patients – clinical trials don’t happen – and they always have a choice to participate or not.
OSP: What is Janssen currently doing to improve patient engagement in clinical trials?
MS: We have been investing in this work and have spoken to over 1,500 patients and caregivers globally to learn about their journeys.
Through this work, we have connected with both clinical trial experienced and clinical trial naïve patients to understand what makes or would make a clinical trial work for them.
We have explored a variety of ways to do this and continually adapt our approach as we learn with each new encounter. We don’t have a one-size fits all approach. We fit the approach to the objective at hand.
OSP: How can pharmaceutical sponsors better connect investigators with patients to get more and better information from clinical trials?
MS: We can empower investigators with relevant solutions and information for their patients. The relationship in a clinical trial is between the investigator (site staff) and the patient, so the more we can provide investigators with tools that will help them facilitate meaningful conversations will ultimately benefit everyone.
This is often an overwhelming time for patients – the language, approach and information that is provided across the clinical trial experience (from introduction to last visit) is so important for patients to feel in control and educated.
OSP: In a perfect world, how would clinical trials operate differently (better) than they do now? What do you think it will take to make these changes a reality?
MS: In a perfect world, clinical trials would “come to the patient” and not interrupt their daily lives.
The reality is patients are also consumers and consumers expect the best customer service and minimal daily disruption (think Amazon, Yelp, etc). A trial would just be easily “added” to their every day. This would not only allow for easier participation, but also provide a real world picture once the product is approved.
As the industry and health authorities gain experience and comfort with things such as digital health, virtual visits, at-home monitoring – we will get there. From my perspective, it is a “must-have” in this digital and instant gratification age.
OSP: What do you expect from the next five, ten years in this area?
MS: Patients have spoken – they want their voice heard and deserve to have their voices heard. And the industry has responded by creating teams and departments dedicated to understanding and delivering a better patient experience. Through this dedication and focus, I expect that we will bring solutions that fit into the patients’ everyday lives.
There is such opportunity through ideas such as wearables, voice-activated technology platforms, and partnerships outside of the traditional industry. Trials will increasingly be shaped to fit patients’ lives rather than requiring patients to adapt their lives to align to the regimen of the trial.
The other area already on the rise is the use of “big data” in clinical trials and how we use it to make better, informed decisions. In 5 to 10 years, I expect this will be the way of working, augmenting trial design and creating better predictions in patient populations.
OSP: What keeps you up at night?
MS: Traditionally, because the pharmaceutical industry is highly regulated, and quality and patient safety must remain a foremost concern, innovation in clinical trial processes, technology and approaches has been slow.
However, when we consider how rapidly technology has revolutionized so many other facets of people’s lives, we must find ways to collaborate with patients and investigators to compliantly tackle the digital world – areas such as social media, patient communities, and digital health – where and how our patients and investigators are living their lives.
Technology changes so rapidly and it creates an extraordinary burden for regulatory authorities to keep up.
As an industry, we must be relentless in driving the adoption of new advances in technology that promise to broaden access to studies reaching a more diverse pool of patients, reduce the demands patients face in studies, and strengthen safety and quality.
There’s too much at stake to settle for doing things the way we’ve always done them.
Trials & Tribulations is a column dedicated to exploring the key trends and challenges facing clinical trials and the greater contract research and manufacturing industry. Have a challenge you are trying to solve? Email me at Melissa.Fassbender@wrbm.com.