Summary: Despite extensive regulations controlling the conduction and oversight of clinical trials there are no requirements or guidelines concerning transitions of care for patients entering or leaving clinical trials. Currently, clinical trials participants face a wide variety of post-trial options. These range from no transitions of care support to open-label extension programs that continue to provide treatment.
This session will identify the gaps, barriers and concerns for patients and their family caregivers who volunteer to enroll in clinical trials. Our presenters assess issues for improving communication between clinical researchers and the standard of care providers. Please join us for this presentation and discussion forum on improving transitions for patients and their family caregivers involved in a clinical trial.
Lee Holland, PharmD, MPH Dr. Lee Holland is the Associate Director, Plain Language Summaries at Certara. She has overseen the drafting of over 250 plain language documents, including summaries, protocol synopsis, clinicaltrials.gov Brief Title and Descriptions, and handouts explaining conference posters in plain language. Lee has also been a patient and caregiver advocate for almost 20 years. She has assisted many patients in accessing healthcare and other needed resources.
During the first two years of the COVID-19 pandemic, she volunteered in a Facebook group to provide her community with accurate information. During this work, she answered questions directly from the public on vaccines, clinical research, and COVID prevention measures. Lee brings her passion for patient advocacy to her work in plain language to educate and empower patients, caregivers, and their families. By combining health literacy expertise with clinical knowledge, she strives to be a voice for the overlooked and forgotten in our healthcare system. Prior to joining Certara, Lee was the Inaugural Research Fellow at Pharmacy Quality Alliance (PQA) in Alexandria, Virginia. While at PQA, Lee was involved in research into patient access to medication and healthcare quality. ______________________________________________________________________ Laura Sheppard, MBA, MA Ms. Sheppard is the Senior Director, Regulatory Services Management and Lay Summary Team Lead and medical writer with experience in document quality control, project management, and clinical transparency and disclosure in both contract research organizations and pharmaceutical environments. She has 20 years of experience in translational science, clinical development, and clinical operations, including 15 years in medical writing, document quality review, and regulatory strategy experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND), Marketing Authorization Applications (MAA) and Clinical Trial Authorization (CTA) applications.
Ms. Sheppard served her three consecutive terms with the American Medical Writers Association (AMWA) asa Director-At-Large. She supports her local AMWA chapter as the NJ Program Chair. Her experience in therapeutic areas includes anti-infectives, cardiovascular, central nervous system, endocrinology, gastrointestinal, immunology, nephrology, neurosciences, oncology, pain management, rare disease, respiratory, urology, and xenotransplantation.
