On July 22nd 2015, PRC Clinical organized and sponsored the inaugural session of the ClinPulse Expert Event Series at Genentech in South San Francisco, in partnership with the ClinOps Toolkit, an online platform gathering resources, information, and advice for clinical trial professionals. The panel, comprised of clinical trial executives, patient advocates, and technology leaders discussed the topic: “What is The New Patient Experience in Tomorrow’s Clinical Trials?” Bruno Gagnon, Executive Consultant and Former Clinical Operations Leader at Roche, BioMarin, and FibroGen moderated the discussion.
President, Xenon Clinical Consulting, Inc.
Director of Communications and Patient Advocate Outreach at CIRM
Senior Clinical Program Leader at Genentech
CEO at LifeMap Solutions
What is the biggest driver of change in the patient experience?
Corey Bridges, CEO and Co-Founder of LifeMap Solutions, is developing innovative digital therapeutics in partnership with Apple and the Icahn School of Medicine at Mount Sinai. LifeMap Solutions integrates health and wellness information with care team guidance into a secure mHealth platform, including smartphone applications to run large investigational clinical studies. He considers that the biggest driver of change in the patient experience lies within our rising expectation towards technology. “We have an expectation that our technology not only will change, but must change, and offer value we hadn’t thought about”. The internet revolution that we’ve seen disrupt a number of different industries is just starting to have some noticeable effects in the healthcare space. Patients are starting to realize this and are pushing for the development of mobile health technologies by demanding to use their mobile devices in new innovative ways.
Meghan McKenzie is Sr. Clinical Program Leader at Genentech. She has been working either with or for patients in research trials for over 20 years in neurology, oncology, ophthalmology and immunology. She pointed out that the internet is now making it possible for patients, and particularly patients with orphan diseases, to find each other and bring their voice to patient advocacy groups. “Patients have a stronger voice, and we need to step up to start listening to them earlier in the drug development process”. Pharmaceutical companies are often reaching out to patients with a product to offer, but they need to start listening to patients much sooner at phase I to understand what is most relevant to them. This will contribute to better drive clinical endpoints earlier in the process. Meghan McKenzie recently led patient interviews by leveraging Patients Like Me, an online platform where patients can share and learn from real-world, outcome-based health data. She stated that it would have been impossible for her to find these patients in the orphan space before this type of platform existed.
Kevin McCormack is the Senior Director for Public Communications and Patient Advocate Outreach at the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency. The agency was created by the voters of California when they approved Proposition 71 in 2004, giving CIRM $3 billion to fund stem cell research in California. A large part of Kevin’s job involves working with the patient advocate community to ensure they are kept up to date on progress in stem cell research and have a voice in that research. From his experience, patients now want to be involved in the drug development process right from the beginning. In stem cell research in particular, patients are being involved as early as the pre-clinical phase. “Patients want to be involved in how those clinical trials are formed, which questions are patients asked and the consent forms that are put together, because they’re the one with the most skin in the game. Patients are now able to bend together, form coalitions and push for their needs and their causes”.
What are the best practices for clinical trial stakeholders to interact with patient advocacy groups?
Kevin McCormack explained that CIRM is directly collaborating with patient advocacy groups in California to put together the agency roadmap for the next five years. Patient advocates contribute to establish priorities in stem cell research and define which strategies should be put in place. Small patient advocacy groups formed around rare diseases often have a very strong involvement to facilitate and influence the research funding process.
“Some small groups are incredibly effective and have a powerful reach. For example, the Huntington’s disease group broadcasts a radio show to 18,000 people on a regular basis.”
Kevin McCormack, CIRM
Bruno Gagnon pointed out that some companies are leading the collaboration between patient advocacy groups and sponsors, creating new positions internally to place patient advocates within pharmaceutical or medical device companies. Patient Opinion Leaders” (POL) are now emerging to represent the patient community and partner with sponsor organizations.
How to be more transparent in the communication with patients and keep them engaged in the research process?
“Within the next five years, we’re going to see a new type of ‘match-making’ apps that perform the function of connecting potential participants with new available studies” states Corey Bridges. Technology cannot yet manage the entire patient recruitment process, which remains very people-centric, but it can and should be leveraged to make “introductions” between patients and clinical trial sponsors. The empowerment of patients and clinical trial participants will also be on the rise. New concepts like ‘The Patient Will See You Now’ popularized by Eric Topol, cardiologist and director of the Scripps Translational Science Institute, are prone to become mainstream in the years to come.
“We want clinical trials to find patients.”
Meghan McKenzie, Genentech
The essential is to figure out how to leverage social media and internet-based technologies to make it more simple and convenient for patients. However, according to Kevin McCormack, there is a struggle to find common ground and a common language between patient advocates and sponsor companies. “Everyone wants transparency but no one really knows what that means.” For business or regulatory reasons, the pharmaceutical industry is limited in its capacity to give away a lot of information on past, present or future clinical trials. However, as patient advocates are becoming more powerful and vocal, sponsor companies understand that there is a growing benefit in engaging with them earlier in a more transparent and collaborative way. They know that patient advocates can help pharma companies not only recruit patients, but also retain them by engaging them more effectively in clinical studies.
Could we leverage best practices from digital marketing, video games, or social networks to increase patient engagement?
It is all about finding appropriate ways to engage and incentivize patients and clinical study participants. There is a “science of user engagement” that has been developing in the past few years. “Video games and social networks are all about analysis and data mining” claims Corey Bridges. User behaviors are being monitored and analyzed, in a de-identified manner, to measure and improve user engagement, increasing “click-through rates” and time spent on these platforms. They’re constantly being tweaked and updated, sometimes on a daily basis, to improve the user experience and maximize user engagement.
“My company is now bringing these procedures to the healthcare field. The results of our user behaviors findings on our asthma app show that user engagement is comparable to major video games or social media apps, which makes it as ‘sticky’ as Angry Birds, Twitter, or Facebook.”
Corey Bridges, Lifemap Solutions.
Could you share examples of specific technologies (smartphones applications, wearables, etc.) that you believe are transformative in the conduct of clinical trials and the patient experience?
“The whole idea of patient engagement is that clinical trials need to be designed around patients” stated Kevin McCormack, “rather than trying to fit the patients in the clinical study process.” We need to design clinical trials around individuals, and figure out how to make it work best from the clinical research perspective.
According to Meghan McKenzie, it is now possible to leverage the latest digital marketing technologies to reach patients. Recently, Stanford enrolled 11,000 patients in 24 hours for a cardiac study. The staggering problem is to validate these new devices and to ensure the quality of the recorded data. It is difficult to verify that patients or study trial teams will always use devices appropriately, across different age groups, teams, or countries.
What are the best practices in sharing clinical data with patients?
Kevin McCormack pointed out that all the research projects being funded by CIRM need to be published publicly. In the quickly evolving field of stem cell research, it is essential to understand that what we’re learning from a particular study can benefit another researcher in another company. “The more open about the findings, the better. The sooner we can tell patients, the better.” In AIDS-related stem cell research for example, there is a great deal of excitement, interest and hope in the clinical study outcomes.
“Patients have a right to know, and we’re not so good as an industry about coming back after the study and sharing the information” claimed Meghan McKenzie. From a community standpoint, this is a missed opportunity because we can learn so much from clinical studies that fail, especially in orphan diseases. Shared databases between sponsors are now emerging, but there is still a long way to go to share data with patients and benefit from learnings between sponsors.
Let’s project ourselves in 2020: What is the biggest change in the patient experience?
According to Corey Bridges, in five years from now, we will have reached a higher level of technological capability, making it possible for sponsors to leverage mobile technologies. We will also cross an equally important milestone which is “cultural readiness”. Pockets of early adopters that are ready to fully leverage these technologies to manage their health will have emerged.
Meghan McKenzie pointed out that the major challenge is to answer concerns about data privacy and data sharing. In the next few years, we will see a growing effort in educating patients about the use of new technologies and procedures. In the context of personalized medicine for example, genome sequencing represents a huge opportunity to better target patient enrollment and conduct studies. However, it is widely misunderstood and patients are raising concerns. We need to make progress on better communicating with patients about data de-identification and confidentiality, to reach a higher level of comfort towards new, disruptive technologies.
“We have more information about health than ever” claims Kevin McCormack “but the health of the American appears to be worst than ever”. Technology alone is not going to solve all the problems. The major change we will see is a growing collaboration between patient advocates and sponsor companies.
“There are too many interests for sponsors and patient advocates not to work together and not to collaborate.”
Kevin McCormack, CIRM