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 engagement, patient 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.

¹ Antidote White Paper, “Considerations For Improving Patient Recruitment Into Clinical Trials, Dr. Aidan Nuttall, 3.23.2012