#TalkClinicalTrials: Pamela’s Experience
Pamela’s initial interest in clinical research and patient health is personal in nature. In the late 90’s, her uncle suffered from avoidable and treatable complications of Hemoglobin SS (Sickle Cell Disease), leading to his premature and preventable death. This experience led to a passionate interest in quality-assessed care. From that time on, she immersed herself in community health and research initiatives.
Now, as a Clinical Project Manager at Clara Health, a Sickle Cell Disease Patient Advocate and a part-time caregiver for her 12-year-old brother living with Autism spectrum disorder (ASD), she continues to share and promote patient voices and needs with regulators, researchers, pharma and industry professionals.
Below, Pamela opens up to Clinical Trials Ontario about her experience in healthcare and clinical trials.
Could you tell us about your work in the Sickle Cell Disease community? How did you become involved in this community?
As a young girl, I immersed myself in community health and fundraising initiatives alongside the Sickle Cell Awareness Group of Ontario (SCAGO) and the Sickle Cell Disease Association of Canada (SCDAC). My initial interest in serving the Sickle Cell Disease community was propelled by hearing my mother speak passionately about the death of her brother in the early 2000’s. My uncle, Sunday Afolabi, suffered from avoidable and treatable complications of Sickle Cell Disease, leading to his death in the late 90’s. Hearing my mother speak about his death drove me to want to address the lack of access to preventative health services, education and quality-assessed care.
As a loyal volunteer of the SCAGO since 2008 and the SCDAC since 2012, my dedicated work with these organizations eventually led to positions where I advocated for effective healthy-lifestyles and disease prevention. By 2016 -2017, I took on patient support research roles within both organizations, where I assisted with patients’ and healthcare providers’ educational programs by developing/disseminating surveys, analyzing their results and reporting to key stakeholders. It was then that I developed innovative methods of optimizing the association’s service delivery to patients and their families – resulting in their improved quality of life.
I currently still volunteer at the SCAGO as a Member of their Research Committee.
Why do clinical trials matter to you, your family, or your community? What motivates you to be a part of the clinical trials community?
Over the years, my love for effective healthy-lifestyles and disease prevention has transformed. My interests now center on finding new ways to prevent, detect and treat diseases. As a patient advocate for individuals living with Sickle Cell Disease and as a sister of someone living with severe ASD, clinical trials represent hope for a brighter future for patients of various communities. For that reason, clinical research is something I am passionate about.
Can you tell us about your role at Clara Health?
As a Clinical Project Manager at Clara Health, I work with sponsor clients, internal team members and vendors to directly improve and accelerate clinical research. This involves managing patient recruitment and retention programs, reimbursement/compensation operations, travel management for trial participants, brand work for clients and many other roles. I have had the pleasure of managing dozens of trials within dermatology, gastroenterology, hematology, infectious diseases and neurology.
At Clara Health you are currently working on recruitment and retention efforts for a COVID-19 trial. Could you tell us about this and your involvement in the clinical trial community?
Yes! And it is quite exciting. It is a phase II interventional study trial, to test the efficacy of LAM-002A in patients with COVID-19. My role in this trial is to ensure we reach targeted enrollment, to ensure we have a sufficient sample size to reduce methodological challenges when it comes to data management and interpretation.
Earlier this year, I also worked with my team at Clara Health to create WorldWithoutCovid; a free public health platform designed to connect people to over 400 clinical trials racing to find vaccines, testing and treatments for Covid-19. As you can tell, we are zealous about positively impacting patient health during these trying times.
In addition, we have embarked on creating a white paper, Patient Centricity in the Era of Decentralized Trials. It details tools to consider incorporating into decentralization strategies for clinical research stakeholders, to accelerate recruitment and retention in the age of Covid-19. We now know more than ever how these resources are of importance and what it means for our communities. I am super proud of my team for the work we have done and will continue to do in this space!
All in all, my involvement in the clinical trial community has been both challenging and rewarding. I have done everything from conducting screenings and follow-up visits as a study coordinator to managing pharmaceutical client’s budgets, branding and enrollment for their clinical trials. I have met the most amazing patients, doctors and industry professionals who are passionate about quality health. It is an experience I would not change for the world and it has made me who I am today. From patient advocates to the pharmaceutical sponsors, the people in this domain are astounding. So, for those out there reading this, keep doing what you do best!
You have a published article about Clinical Trial Retention. Can you tell us more about it and what the findings mean?
Upon entering this field of work, I realized clinical trials often fail to sustain their target sample size within the envisioned timespan. While extensive research for recruitment communication exists, it dawned on me that limited attention had been extended to understanding if and how discussions of retention are articulated to potential participants during initial consultations about trial participation. This led me to systematically investigate trial consultation audio-recordings, as a valuable research tool for documenting discussions of retention between trial staff and potential participants.
My findings revealed a lack of discussions of retention across the majority of consultations (79%). This analysis implied the likely possibility that most consenting participants were unaware of the 18-month long follow-up procedures required of them. Of the remaining 21% where discussions of retention were present, the discussions often contained inaccuracies, lacked critical details, required participant prompting and contained an unbalanced focus on patient’s rights to withdraw. Such consultation techniques raised concerns of whether informed consent can be considered present when initial retention information is inadequate or absent.
Although it is ultimately up to potential participants to commit to trial and provide follow-up data; balanced communication and appropriate/effective communication techniques of retention processes from trial staff may influence how likely potential recruits will remain within clinical trials. Thus, there is a need to consider modifications to the current consultation model.
So why is this important? Because meeting recruitment goals is often the first point of challenge for clinicians. Up to 20% of participants drop out before trial ends, which significantly reduces the potential for trials to influence clinical practice (diminishing their credibility). In the case of Phase III trials (that aim to test health intervention on up to hundreds to thousands of participants from a pragmatic ‘real world’ perspective) – this can give rise to uncertainty about treatment efficiencies, impact financial investment of the clinical trial funding agency and cause missed opportunities for those who could have benefitted from them.
Do you have any advice for people who are interested in participating in clinical trials?
- Ask lots of questions! Take your time and talk things through, don’t rush to join a trial. Ensure you are informed on what will be expected of you (number of visits, trial duration, fasting requirements, etc.). You want to make sure you have all the information before you sign up!
- Knowledge is power, find out as much as possible about where you are in your health journey. If you have exhausted standard treatments, think about phase 1 clinical trials. Make sure that you understand the objectives of the trial and what it might mean for you.
- If you know a friend who may be interested in a trial, refer them to your clinic for screening! Many people are interested in trial but just don’t know how to get involved. Making that introduction can make a world of difference for someone.