What Does It Mean to Put Patients First in Clinical Trials?
In clinical research, we’ve finally reached that point where the phrase “patient centricity” carries real meaning. Patients now have more input in the drug development process and more opportunities to share their experiences to help get promising therapies to market. These new patient first developments are welcome. Some would even say long overdue.
And yet, there’s no guarantee that greater patient inclusion will pay off with more timely, efficient and cost-effective trials and ultimately approvals. At the same time, we can’t stand to lose out on the benefits that the patient first perspective brings to how we develop and test new products. So how can various industry stakeholders (sponsors, CROs, sites, vendors, etc.) work together to ensure the best experience for our clinical trial participants, while maintaining the scientific integrity of a research study? How do we approach study design and execution to ensure trial subjects would recommend the experience to family or friends? After all, as we insert into every Informed Consent Form, participating in a research trial is completely voluntary!
The above one is definitely a loaded question with many answers. In my dozen years in the industry, I’ve observed two key components of a successful approach to patient-centricity: Minimizing the patient burden; and maximizing the patient voice. Here are some considerations for sponsors and clinical research organizations as they design patient first trials, recruit and manage patients and capture results:
Minimizing the Burden
Clinical trials ask a lot of patients. We ask them to attend numerous clinic visits within strict protocol windows, monitor and record symptoms and health data on a daily basis (or more frequently!) and alter the way they typically take medicine in order to not coincide with study drug… just to name a few. To help with this, new technologies like in-home devices, apps, wearables, and reminder systems have entered the picture in a big way in clinical research. As the U.S. Food and Drug Administration encourages greater use of patient-focused drug development, siteless trials, and real-world evidence and data, the industry must make sure patients aren’t overwhelmed with their responsibilities.
Drug companies, CROs, clinical trial sites, researchers and technology providers all need to take this into account, working together as much as possible. It’s our job collectively to ensure that our processes, designs, systems and technologies are patient-friendly.
With the move to patient-focused drug development, it’s important for all digital solutions to avoid placing a technical burden on patients, and equally important for sponsors and CROs to choose technologies that are easy for patients to use. Technology providers also must ensure that their platforms work well with other solutions, as patients often use more than one technology or device.
Patients appreciate ease-of-use. The risk of patients abandoning their participation or failing to adhere to medication protocols is high if they’re unable to easily use a device.
Maximizing the Voice
Every time a patient raises their hand to be a volunteer in a trial, they’re helping us. We need to listen to what they have to say.
Today, clinical researchers are doing more than ever to include patient input. That input can include trial design, medication protocols, and frequent communication on treatment effects and health status. It’s all about including the patient voice, as the Patient-Centered Outcomes Research Institute describes in its definition of patient engagement: “The meaningful involvement of patients, caregivers, clinicians and other healthcare stakeholders throughout the entire research process – from planning the study to conducting the study, and disseminating study results.”
Despite the much greater focus on patient engagement, we have a long way to go to include patients as full partners. Clinical researchers must design and test patient engagement models that not only capture patient input but also use it in meaningful ways to evaluate results and drive future studies.
We must remember these are patients often with serious medical conditions who have volunteered to help. They are experts in their own health. It’s imperative that we build in ways of inviting patient input, capturing what they tell us and including it throughout the process. Then it is up to us in the industry to design solutions to make the patient journey most enjoyable!
As an industry, we recognize that clinical trials simply aren’t possible without the active involvement of patients. But often our traditional ways of designing and conducting trials fail to take full advantage of the patient perspective. We’re changing – but it takes time.
All of us involved in trials should keep an open mind toward new processes and technologies and stay on top of the changing environment. That certainly includes embracing engagement with patients as they actively participate in the development of new therapies.