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Phase I Ethnobridging Clinical Trials

In this article, we explore key participant retention strategies in Phase I clinical trials. Effective participant recruitment strategies help to ensure that we maintain a healthy pool of subjects, and participant retention is paramount to conducting successful studies. Phase I participant retention requires even further attention, as participants are usually admitted to the clinical pharmacology unit (CPU) for one or more overnight treatment periods. In addition, they may need to be scheduled for outpatient visits over a period of 6-12 months once the inpatient portion of the trial is completed. Therefore, strong communication about logistics becomes very important.

Altasciences utilizes a proprietary, institutional review board (IRB)-approved retention program that has proven to be effective at increasing retention rates. With 100% retention rates in some cases, we have implemented a variety of different strategies to ensure participant compliance throughout the course of our studies. Some of the main strategies for successful patient retention are discussed below.

Study Scheduling

We share the study visit schedule with the participants as soon as it is finalized to minimize conflicts and allow participants to arrange their schedules around work, school, and family activities. The goal is to ensure the highest possible compliance with all the study visits required in the protocol.

Reference Cards

Prior to the study, we provide participants with reference cards that remind them of prohibited/allowed activities, including dietary restrictions or other requirements that would interfere with the study results.

Study Orientation

To ensure that participants fully understand the requirements and expectations during the treatment period of the trial, we perform check-ins with them at the CPU immediately preceding their dosing and reevaluate scheduling as needed for their unique circumstances

Visit Schedule

At discharge from the CPU, we remind participants of their next check-in times and provide them with schedules to have on hand as additional resources.

Recruitment Team

Our dedicated in-house recruitment team makes phone calls and sends emails and text messages as additional reminders to participants. The team is available for questions and assistance as needed.

Completion Bonus

With IRB approval, we pay a stipend for each visit, providing a bonus upon study completion as an incentive for participant retention.

Entertainment

Altasciences offers participants access to entertainment networks and resources, including DirecTV, game consoles, Netflix, computer access, books, magazines, and free Wi-Fi. We provide a wide variety of ethnic-specific entertainment, and host events such as movie nights and English lessons for studies with long confinement periods.

Special Meals

If permitted by sponsors and protocol, we make sure to provide participants with ethnic-specific, diabetic, or vegetarian meals during their time on site.

Transportation

Altasciences offers a variety of transportation options and provides travel reimbursements, when necessary, to allow study subjects a safe and convenient way to get to and from scheduled study visits. This also helps ensure study visit compliance with the protocol.

The overall goal is to accommodate all participant needs as the study protocol allows, setting clear expectations with open communication, while promoting participation that does not add any financial or personal stressors to the participants. These participant retention strategies, established with our extensive experience, combine to make Altasciences the premier choice for study participation.

Working as a flexible, attentive extension of your team, we offer comprehensive drug development services to move your molecule forward.

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