Case Study | Central Nervous System Study | Challenging Patient Population

Central Nervous System

Challenging Patient Population

Sponsor

This study is sponsored by a biopharmaceutical company who is partnered with a fortune 500 company on the development of this study drug with a unique mechanism of action in Alzheimer’s disease.

Project

A Phase 3 multi-center trial, 12 month safety and efficacy study evaluating an oral study medication in patients with mild to moderate Alzheimer’s disease. Over 1000 patients enrolled across 120+ sites in 10 countries worldwide with approximately 60 sites in the United States. Patients will be followed for 12 months of study treatment and offered open label study drug at the end of that time for a period of at least one year after which minimal evaluations will be required and patients will be followed for safety.

Challenge

How do you ensure compliance and retention in a patient population that is dependent on caregiver assistance? This patient population has many obstacles to address when committing to a year-long study. Our experienced staff helps sites address those obstacles and find unique ways of helping patients and their caregivers comply with study visits and study requirements.

How do you ensure compliance and retention in a patient population that is dependent on caregiver assistance? This patient population has many obstacles to address when committing to a year-long study. Our experienced staff helps sites address those obstacles and find unique ways of helping patients and their caregivers comply with study visits and study requirements. For example, ProTrials has helped sites develop and implement tools for patients and caregivers such as visit reminders and compliance reminders; we have arranged for transportation to and from visits or reimbursement for transportation. Our monitors ensure that the sites have continual communication with their patients and caregivers to answer questions and remind them of their responsibilities. ProTrials has forged an excellent relationship with the Sponsor and works hand and hand with them to ensure study compliance and the completion of quality data.

Results

ProTrials has worked closely with each site to ensure optimal patient retention and compliance. If a patient is considering withdrawing from the study, we proactively work with the site to determine the reason for a possible withdrawal and in many instances are able to overcome those obstacles (e.g., transportation issues).

ProTrials has worked closely with each site to ensure optimal patient retention and compliance. If a patient is considering withdrawing from the study, we proactively work with the site to determine the reason for a possible withdrawal and in many instances are able to overcome those obstacles (e.g., transportation issues). If there are issues with dosing, we work with the site on ways to improve compliance (e.g., electronic pill reminder tools). ProTrials is available to sites at all times and we are able to provide the support that sites need to work closely with their patients.

In addition, ProTrials has completed four data-sweeps for this study in order for the DSMB to assess safety of the study drug and brought in 100% of required data fully monitored during that time. Our data monitoring and collection has remained above 93% for the duration of the study and our query rate has remained below 0.07% for the entire study. Our focus continues to be quality data, study compliance and maintaining excellent relationships with sites to ensure that both of these tasks can be met.

Sponsor Feedback

“We have worked with ProTrials for years across multiple programs and value their expertise, flexibility and responsive customer service. ProTrials’ seasoned professionals have contributed both domestically and internationally, in-house and in the field, whatever our needs have been ProTrials has been our solution!”

-Sponsor, Sr. Director, Clinical Operations