Parexel’s First Patient Ambassador on Being a Voice for Patients

You’re Parexel’s first Patient Ambassador. Why was the role created?

I’ve been on both sides of the patient care paradigm, and I can tell you that there is a huge gap of understanding between those delivering care and those receiving care. This role was created to close that gap within the realm of clinical research. At Parexel, our mantra is: “Patients first.” The vision for this role’s future is to ensure that patients’ and caregivers’ needs are at the forefront in designing clinical trials, and that trials are as easy as possible to participate in. This is the emerging model of drug development: fitting the study into a patient's life, not disrupting a patient’s life for the study. 

I see myself as a voice for patients, inclusive of caregivers; to give them a seat at the table in clinical trial protocol development and burden reduction. We've been waiting for this opportunity for a long time. It's an honor to be a pioneer in this regard and serve this stakeholder group who needs to be heard and seen. 

What does your role look like tangibly? 

I take the recommendations of our patient advocacy group partners, patient insights team, and patient advisory panel members and operationalize them into a trial. I work closely with our Head of Diversity, Equity, and Inclusion to ensure that a wide variety of viewpoints are represented. In a meeting with a study sponsor, I demonstrated how what’s most important to patients and caregivers translates to value in terms of optimal trial delivery.

Can you give an example of how you add to those conversations? 

Let’s say we’re looking at a protocol for a trial that includes an exploratory lung biopsy. First, I’ll collaborate with our physician on the study to quantify the necessity of the biopsy. Then, being a cancer survivor, I can say to everyone in the meeting, “Have you had a lung biopsy?” I had a liver biopsy, which is very similar; it was an inches-long needle that I had inserted into my liver. It was painful, invasive, and traumatic. It required a day off from work; I wasn't able to drive; I needed someone with me. I will ask, “Did you take all of that into account when designing this protocol?” 

Only someone who has experienced this firsthand can speak to it candidly and acutely. I know this is going to be a pain point for patients where they may drop out. As a risk mitigation strategy, I will help create educational materials to decrease fear and anxiety and increase awareness of particular procedures. Patients want to know what to expect. This translates to better retention in a trial. 

"Financial toxicity for patients is real, and the expectation that patients will just “handle this” is unrealistic and lacking compassion."

Are there other aspects of the trial journey or experience that might be other unseen pain points? 

Travel to and from a site, family caregiving (child or elder), and number of study visits/appointments are three burdens that we often hear about that preclude patients from participating in clinical trials. Financial toxicity for patients is real, and the expectation that patients will just “handle this” is unrealistic and lacking compassion. Other barriers include lack of accessibility; for example, sites that aren’t navigable for those of different abilities, lack of diversity; for example, patients of color not seeing investigators who look like them, and lack of communication between investigators and patients. Unconscious bias translates to automatic deal breakers for potential participants. 

What is one thing about how pharma conducts patient engagement that you’d like to see changed? 

There must be more partnerships with patient advocates and patient advocacy groups. As a patient advocate myself who has volunteered for several patient advocacy groups and worked for a nonprofit organization, I know that these are the entities that patients trust when seeking disease related information. Patient advocacy groups probably have the most collective data about day-to-day life with a condition such as cancer or a rare disease. 

Patients are not still not hearing about clinical trials from their doctors as much as they should. They're routinely hearing about clinical trials from patient advocacy groups. Having been in and around pharma for 20+ years, I’m surprised at the hesitation that industry has to speak with patient advocates and seek their representation on the design and delivery of clinical research. The internet has broken down silos between patients and providers. Hopefully, we can do the same with patient advocacy groups and industry. 

You are also a caregiver. How can we better support the caregivers of patients participating in trials? 

Too often in the past, caregivers have been minimized and diminished. Caregivers should be as fully included in the clinical trial process as the patient. In other words, every support and intervention that is afforded to the patient should also be afforded to the caregiver, whether that is travel, access to data, communication, or consent (if the patient wants/needs that to happen). If the patient identifies the caregiver upfront as a part of their support system, then from there forward, everything that that the patient undertakes should be equally accessed by the caregiver. 

What is your definition of patient centricity in clinical research? 

To me, patient centricity is a somewhat redundant term. Working in healthcare, we should all be patient centric. What I’m interested in is moving from patient centric to patient-led. Patient centricity unto itself is irrelevant without tactics to propel actionable change. The Patient-Focused Drug Development (PFDD) guidance from the FDA drives the whole remit of my role. Patient involvement will go from a “nice to have” to a “need to have” to a “must have” in clinical research design. We know that the FDA is now requiring diversity plans for phase 3 pivotal trials. What better contributors of these plans than underrepresented patients who are experts of their lived conditions? At Parexel, we are developing training and toolkits for investigators and sites, designed with patients, by patients, and for patients, to comply with PFDD regulations and thus reach more patients for clinical trials. It’s a true multi-stakeholder approach with patients leading the way. 

"It took a global pandemic for change and to force us to think differently."

What have you seen as the evolution of patient-centricity in clinical research? 

In the past, it was never really considered. It took a global pandemic for change and to force us to think differently, unfortunately. Formerly marginalized groups were given a platform and a voice, and one of those marginalized groups is patients. 

There has been an evolution in addressing stigmatic concepts: cancer, mental health, addiction, patient safety, disabilities, diversity, sexual preference, gender identity, etc. I’m grateful to be alive to witness us as leaders in healthcare shining a light on our differences and our challenges and democratizing them. It’s no longer okay to say nothing. If you lead with heart from a place of seeking understanding, even saying the wrong thing shows a vulnerability to want to know better and do better. We should know better now. The next step is doing better for patients.

What would you want to express to industry leaders about what it means to be a patient? 

I’ve heard pharma organizations say, “We employ patients as decision-makers, because after all, we are all patients.” If someone had their appendix out when they were 12, they do not qualify as a patient. A patient is a person who is forced to make accommodations and workarounds in their daily life just to function at the baseline of a normally able bodied or neurotypical person because of a chronic condition. People who self-identify openly as patients are patients. So, no, we are not all patients. This is an important distinction to those of us in the patient community who are advocates and/or subject matter experts working in or consulting for industry on behalf of clinical research. 

What drives you in your work as patient advocate and Patient Ambassador for Parexel? 

While I’ve participated in clinical research as a healthy participant, I wasn't in a clinical trial for my cancer treatment. I’m optimistic that one day a clinical trial will improve Emmett’s quality of life. I am alive today because of patients who have participated in clinical trials. It is very important to me in my role as Patient Ambassador that I honor their sacrifice. 

As an active member of the colorectal cancer patient advocacy community, I spoke to many of my friends who were in clinical trials and asked for examples of what I could improve. Some of them have since passed because treatments failed them. What drives me and inspires me is to be their voice, to carry on their legacy, and to make it better for future patients going through this. Because my friends told me that’s what they would want. 

For more information, visit parexel.com.