Missing patients, and therefore their data, pose a threat to clinical trials. This missing patient data increases the risk of additional queries from regulatory agencies regarding the potential effect on the endpoint data and therefore the significance of the safety and efficacy findings. Study sites often lack the resources and time to find patients who are lost to follow-up (LTFU). Although there are patient tracking services available, they vary in their effectiveness in both finding, and then retaining, patients. Consideration of how to mitigate missing data from missing patients in the initial planning phase of a clinical trial can help identify how to avoid missing patients in the first place and how best to find patients who do drop out.
Bernard Hall, Project Manager, Bioclinica LTFU
Bernard joined Bioclinica in July 2016 following 12 years as a patient recruitment specialist with Medici (acquired by Bioclinica). Bernard began as the in-house call center manager overseeing study patient recruitment and retention programs. He has managed the LTFU practice for the last seven years, which employs a purpose-built lost-to follow up portal. Bernard has contributed to the successful recruitment of over 200 programs in more than 60 countries, spanning numerous therapeutic areas. Prior to Medici, Bernard taught high school in the Philadelphia school system. Bernard attended the Community College of Philadelphia.
Who Should Attend?
Individuals involved in:
- Clinical Research
- Clinical Development
- Clinical Project Management
- Clinical Trial Study/Protocol Managers
- Clinical Operations
What You Will Learn
By participating in this webinar, you will:
- Understand the effect that missing data from patients LTFU can have on the success of the clinical trial
- Know how to proactively plan for patients LTFU in the initial stages of the clinical trial
- Be able to identify the options available to find patients who are LTFU
- Understand the patient tracking option that is best for the clinical trial
Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new life-improving therapies more efficiently and safely. Successful clinical trials require the ability to see key details and uncover hidden insights, and Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval. The company’s cloud-based offerings include medical imaging; cardiac safety; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site payments and forecasting; pharmacovigilance; trial management; and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers an integrated App xChange partner ecosystem, a global network of research sites, patient recruitment services, and post-approval research expertise to provide committed, detail-focused service through all stages of drug development. The company’s thousands of employees serve more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia.