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Keeping patients at the center of clinical trials

October 26, 2021

Clinical trials help researchers learn whether investigational treatments are safe and effective for people. Recruiting and enrolling sufficient numbers of patients in order to achieve this goal is key; however, over two-thirds of clinical trial sites fail to meet their original patient enrollment projections for a given trial1. In the next part of our series focused on how we include the patient voice in all we do at Takeda, we look at how our Patient Recruitment and Retention team (PR&R) works to engage, enroll and retain patients in clinical trials. We spoke with Amanda Decoker, director of Patient Recruitment & Retention at Takeda, to learn more about the role PR&R plays in the clinical development process and how the team works with Takeda’s Patient Engagement and Patient Advocacy teams to support patients in their journeys.

Patients are the core of clinical trials – their participation allows us to better understand their needs so that we can improve the quality of life not just for them, but for the broader patient population. At Takeda, our PR&R team acts as a Center of Excellence as part of the Global Clinical Operations team. They work to support our clinical study teams in effectively planning for and achieving on-time enrollment for clinical trials. They do this by developing and executing innovative patient recruitment and site engagement strategies that leverage strategic partnerships, health care data, and innovative technologies. Examples of such strategies include patient identification through the standard of care pathway utilizing the analysis of diagnostic/lab data as well as high touch patient concierge services.

“We work very closely with a number of cross functional teams within Takeda to understand the individual nuances of a specific protocol,” said Amanda Decoker, director of Patient Recruitment and Retention at Takeda. “This includes the challenges as well as the opportunities from a patient’s perspective We then collaborate with the study teams directly to devise a solution that will meet the needs of our patients as well as ensure that timelines are met.  It’s imperative that we meet or reduce timelines wherever possible to allow for the collection of study data to determine if a specific investigational medication has the potential to be brought to market to benefit the broader patient community.” 

Leveraging data to build enrollment plans

The PR&R team routinely begins engagement with the clinical team at the point of protocol synopsis. “Early engagement is essential to allow adequate time to complete a thorough analysis of the broader landscape prior to the start of screening for an individual protocol,” said Amanda. “This analysis includes review of epidemiology and real-world data, the patient journey including symptoms, diagnosis, education and treatment plan, as well as the patient’s broader circle of care. Key insights from this review are then overlayed with the therapeutic and study specific challenges and opportunities to develop a customized recruitment and retention plan.” 

Working together as P3

The ways in which our P3 teams (patient engagementpatient advocacy and PR&R) work together may differ slightly depending on the clinical trial protocol, but the goal of each team is to begin engagement as early as possible in an asset’s development lifecycle. The patient engagement team works directly with the patient community to understand what their needs are, which then helps PR&R to shape recommendations or individual designs for a specific protocol. As for patient advocacy, the team works with the patient support communities to understand the landscape and which key advocacy groups PR&R should foster an ongoing engagement over the course of the development program.

“We have an opportunity, not just in PR&R, but with P3 as a whole, to make a positive impact for patients and to make certain that they’re the best possible experience during their participation in a Takeda-sponsored trial,” said Amanda. “At Takeda, we focus on the patient’s needs and we look at their journey holistically. Everything we do is centered around the patient and we want to make certain that we are doing all that we can to meet their needs.”   

Learn more about Takeda’s approach to patient needs.

Antidote White Paper, “Considerations For Improving Patient Recruitment Into Clinical Trials, Dr. Aidan Nuttall, 3.23.2012


From Manufacturing to Commercial
I am currently the Product Operations Lead for enzyme replacement therapies to treat rare metabolic diseases, and it’s my job to ensure that our manufacturing and supply strategies enable the supply of our drug products to patients around the world. I work cross-functionally with master planning, Biologics Operating Units, Quality, Regulatory and other departments and local operating committees to help build launch strategies in different countries.

Through my tenure, various types of work have offered me the opportunity to develop my expertise in different roles, starting in a manufacturing plant where teamwork is so critical to operations. Now within the commercial organization, I have a global role in which I am deeply involved in various processes taking place in different parts of the world. Before moving to the commercial side, I hadn’t appreciated the full extent of the global scope and reach of our products, and it’s been exciting to discover this through being an active part of that process.

Every day brings something new, and I love facing fresh challenges, learning new things, and having to leave my comfort zone. Mastering novel approaches and overcoming the many hurdles I’ve faced has helped me evolve as a person, and I feel very lucky to have had the opportunity to grow with the company.

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Having First-Hand Experience of the Challenges Patients Face

When my daughter Emily was 5, she was diagnosed with a very rare type of arthritis called systemic-onset juvenile rheumatoid arthritis, also known as Still’s disease, a full-body arthritis and inflammation. By the time we received the diagnosis, she was no longer able to walk or even hold a pencil. All of her joints were swollen; she had high fevers and was sick all the time. As is often the case with rare disease patients, it took us many years to find the right treatment plan. Happily, she has been in remission for over two years and is now in her second year of college.

After taking care of Emily full-time for eight years, I decided I wanted to work for a company with a rare disease portfolio so that I could help other people facing similar challenges, and I also wanted to work for a company with a patient-first focus. I feel now that it was inevitable that I would work here at Takeda – it is the right place for me.

I’ve been with the company for 11 years, and during that time both the company and I have been through many changes. The company’s core value of “integrity” is something that really resonates with me. Having the opportunity to see the patients, and the positive impact we have on people’s lives, has always been near and dear to my heart. Having first-hand experience of the kind of challenges that my daughter and our family went through, I always have a strong sense of compassion for our patients, which I rely on to keep myself and my team motivated.

Giving Back and Spending Time with Patients and Families

The one aspect of Takeda that I am inspired by the most is the dedication to patients around the world. There are clear examples through the CSR initiatives, employee resource groups, and commitment to the community through programs such as Takeda Cares in the U.S. I personally do a lot of volunteer work to support patients and I’m proud to work for a company that shares the same values.

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One of the projects close to my heart is the SeriousFun camps, particularly the Hole in the Wall Gang Camp in Connecticut. The SeriousFun camps were set up to offer children struggling with different forms of cancer and rare diseases an escape from the fear, pain, and isolation of their medical condition, offering opportunities for them and their families to have fun. I’ve volunteered at the camp as a cabin counselor, a Family Pal, and even an archery instructor. It gives me a chance to interact one-to-one with patients and families, and it’s a fantastic experience to be immersed in camp activities and see the emotional growth of the young patients and their families over the week.

New Standards in the Way We Work

Today, we are facing many challenges, including the COVID-19 pandemic. We transitioned to remote work where possible very quickly and established teams dedicated to safeguarding supply chains to minimize potential disruptions to patients. We always need to be in regular contact and keep ahead of international developments that could affect our packaging plants, worldwide distribution networks, and international couriers shipping the treatments to patients in need. It’s also vital to continue important outreach efforts with patient groups, advocacy teams, doctors, and patients to keep them informed, listen to their needs and reassure them that we are acting to ensure that the products are going to get there, despite disruptive world events.

“Bloom where you are planted”
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I’ve learned a lot and have had so many different opportunities during my career, but whenever anyone asks me where I see myself in five years, I have to tell them that I don’t know but that I just want to be happy wherever I am. I always say that I bloom where I’m planted; whatever opportunity I’m given, I flourish in it. I always try to be happy with a smile and a laugh–I simply want to bring happiness and joy to people’s lives.