Lessons learned – A Practical Perspective on Cystic Fibrosis Clinical Trials
Sponsored by: Covance
- Cystic Fibrosis
- Clinical Trials
Date: 15 October
Time: 4PM London/11AM New York
Designing and conducting clinical research in a challenging indication and a dynamic environment
Cystic Fibrosis (CF) clinical trials are inherently challenging due to the complexity of the disease and its lifelong impact on the patient’s daily life. Although these patients’ treatment schemes are often extremely charged, there is still an unmet need in this arena. Sponsors are facing a dynamic and competitive research environment where they must appeal to well-educated patients and make their trial stand out among highly experienced sites.
Running a successful CF trial requires careful attention to protocol design, alignment to the current standard of care and the ability to handle a heavy schedule of patients and multiple trial endpoints. From investigators to CROs, sponsors must establish early collaboration with all stakeholders and ensure the appropriate use of technology to take on operational challenges and prevent unnecessary risks to their study.
Join this webinar to hear about valuable lessons learned from recent CF trials. You will hear about barriers faced in today’s research landscape and several approaches to handle common issues that these difficult trials. The speakers will also share insights on both clinical and operational solutions along with best practices to align trials to better address CF disease specificities and meet the needs of CF patients.
Anna Karina Putineanu, MD,
Senior Medical Director, iiGM
Dr. Putineanu has over 22 years of medical and clinical research experience across multiple therapeutic areas, including rare diseases, internal medicine, infectious diseases, respiratory, vaccinology - and the intensive care unit (ICU). She also has extensive experience in building, developing and leading medical and clinical global phase I to IV programs and teams, with proven leadership in building and guiding global teams, managing complex relationships and aligning interdisciplinary teams.
Veerle Van De Velde,
Senior Medical Director, IIGM
Dr. Veerle Van De Velde obtained her medical degree in 1995 and worked as a sub-investigator in the Respiratory Department of the University Hospital in Ghent. She spent four years doing clinical research in Phase II, III, and IV trials in asthma, COPD, respiratory infections- and pulmonary oncology under the guidance of Prof. R.A. Pauwels. Veerle has over 20 years’ experience in the industry, first as a drug safety and later as global trial lead physician. She has worked on clinical trials in various indications with the main area of focus being rare respiratory disease.
Key Learning Objectives
- Understand the key challenges in todayâ€™s CF research landscape
- Learn about approaches to attract highly experienced patient and sites
- Get insights on how to design protocols to better align with CF disease specificities
- Hear about solutions for using technology and collaborative practices to advance trials
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