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In our first blog for International Clinical Trials Day, we focused on how we, as an industry, are blazing a trail towards faster and more efficient clinical trials. In this second piece we want to focus on the one thing none of us can do without if we are to be successful in our efforts — the patient.
Patients are at the heart of our trailblazing ethos — they could be considered the true trailblazers among us, especially when they’re participating for the first time. Their willingness to involve themselves in a new process, and to trust clinical researchers and product developers with their time and wellbeing, is a significant contribution.
As an industry, can we do more to improve access and the overall experience of these trailblazers? There are barriers that often derive from trial complexity, deeply rooted historical mistrust, or a lack of awareness about clinical research. And what of the more tactical barriers, such as the cost of missed time at work, lack of accessible sites, and inconvenient visit time availability?
From a policy and social element, there are opportunities to elevate clinical trial participation as a social contribution. Imagine if it were treated as a workplace benefit, complete with support for cost-free leave, akin to volunteer days or national defense service.
In a Velocity survey of 7,000 patients, more than half of respondents said they joined a study primarily to help advance science, while just one in four said compensation was their main reason for joining a trial. There is evidence, however, that compensation (and taxation) is a bigger disincentive to those who do not participate in studies, particularly those from more impoverished backgrounds and that, in turn, is related to diversity in clinical trials. In the U.S., after patients overcome the many barriers to study participation and blaze a trail to the benefit of all, they face taxation on any compensation over $600 annually, diminishing the value of their contribution.
Such are the political and societal barriers patients face. But what can we control here and now?
First, there is a need to evaluate and improve how we communicate and properly support patients and their stakeholders about the industry’s goals in clinical research. Very few individuals, and a significant number of clinical professionals, don’t know how new therapeutics get developed, even in the post-COVID era. Making the case that clinical trials “are a good thing” shouldn’t be difficult, but can we all say we do that? The surveys say we don’t (NIH; NIH Clinical Research Trials and You). This highlights a broader need for education and community engagement to foster open conversations about clinical research — a goal that requires industrywide collaboration like that shown for Clinical Trials Day.
The good news is Trailblazers are Among Us to help address some of the challenges.
Addressing challenges begins with a deep understanding of the experiences of those affected. In clinical trials, this means grasping the patient’s lived experience. The industry must collaborate with patients and their communities to design each trial, ensuring the research approach aligns with the patient’s priorities.
Patients and caregivers are lived experience experts, and there are thousands of them worldwide collaborating with drug developers and clinical research sites to provide advisory support. These individuals are trailblazing clinical trial access for others.
Sanofi is honored to collaborate with individuals from across more than 30 countries in an advisory capacity for 100% of the indications, programs, and clinical trials in development. These trailblazers help us go above and beyond, to do the very best for all patients.
Patients are also trailblazing research advancements by creating advocacy groups to study, fund, and accelerate the access to healthcare solutions identified in their communities. Many advocacy groups started with just one person’s desire to trailblaze a path to a cure, treatment, or policy change to improve the lives of many. Sanofi, along with 23 other industry and US advocacy organizations, is proud to be part of PALADIN (PALADINconsortium.org) working together to make it easier for patient advocates and sponsors to collaborate and transform the pace of drug development.
How we communicate about clinical trials, and the challenges faced by patients to find a study, remains a significant barrier to participation. Sources to find a study are fragmented and not easily identifiable.
However, patients and some industry leaders are trailblazing ways to help patients connect with relevant clinical trials directly. Together with artificial intelligence (AI), and input from patient advisors, these technologies are growing in number and capabilities.
At Sanofi, we are progressing our goal to leverage AI at scale, which helps us deeply understand patient priorities so we can develop medicines, and support programs, that address their most pressing needs. As part of our Patient Community Promise, we commit to remote and digitally enabled clinical trials thus making it easier for individuals to participate.
At Velocity, we recognized how technology could drastically improve the experience for patients and communities seeking clinical trials. In 2023, we launched VISION Engage, a patient mobile app that has already been downloaded more than 50,000 times. Our technology is making clinical trials more accessible to all by removing many points of friction. We’ve learned that people are choosing to browse and self-screen for studies on nights and weekends, outside of the typical business hours sites provide. We’ve also successfully enrolled patients who had not responded to direct phone calls, emails, or texts for a year or more prior. And, for whatever reason, Thursdays are great. Our response rates for new study notifications are highest on Thursdays.
Velocity was honored to win the 2023 SCRS Excellence in Patient Centricity Award, created and sponsored by Sanofi, for initiatives mentioned above. Such support, recognition, and collaboration are opening many doors for promising advancements.
There are Trailblazers Among Us, and yet a tremendous amount of trailblazing is still urgently needed to improve clinical development efficiency. Regardless of the destination, we all know the right decisions start with the patient in mind.
This is the second of two articles in a collaborative series written by Vicky DiBiaso, Head, Patient Informed Development & Health Value Translation, Sanofi, and Paul Evans, President and CEO, Velocity Clinical Research.
