In this free webinar, learn more about the challenges and benefits of collecting real-world data (RWD) in continued and early access programs, along with opportunities to collect RWD that are scientifically robust, practical and ethical. Attendees will learn about the impact of varying global regulations on data collection and the additional complexity of its operationalization. The featured speakers will discuss ways in which the regulatory and operational challenges may be mitigated and alternate approaches for data collection.
TORONTO, Oct. 24, 2023 /PRNewswire-PRWeb/ -- Data collection opportunities within continued and early access programs can vary significantly by country. Within a country, there also may be different regulatory pathways to pursue. Most non-clinical trial pathways for access require or allow safety data collection by the manufacturer; however, guidance on acceptable effectiveness or health outcomes data collection is limited. Many also eliminate the requirements for protocol, patient informed consent and ethics committee approval, which are necessary elements for data collection, thus limiting the ability to collect data.
Although continued and early access programs are not a substitute for data collection in clinical trials, they may provide supplemental data that address a variety of research questions that could be informative for multiple stakeholders, including regulatory bodies, payers, clinicians and patients.
The existing guidelines that do address the possibility of data collection fail to be specific enough, leaving the door open for interpretation. It is also important to note that these programs that anticipate more robust data collection (e.g., United States Treatment Use Protocol, United Kingdom Early Access to Medicines Program and France Early Access Program) also involve a more extensive approval process, including protocol and informed consent requirements.
Although continued and early access programs are not a substitute for data collection in clinical trials, they may provide supplemental data that address a variety of research questions that could be informative for multiple stakeholders, including regulatory bodies, payers, clinicians and patients. Data collection within these programs allows for generating RWD in typically broader patient populations compared to those analyzed in clinical trials. RWD generated in the pre-approval phase could augment primary clinical trial outcomes in submissions for market approval and are useful for informing future real-world use.
As the number of early access programs and the use of RWD to inform market access continue to grow, so will the benefits of collecting RWD in these programs.
Register for this webinar to learn more about the challenges and benefits of collecting RWD in continued and early access programs, along with opportunities to collect RWD that are scientifically robust, practical and ethical.
Join the following experts from the PPD clinical research business of Thermo Fisher Scientific: Emily Speas, Director, Project Management, Access Solutions, Peri- and Post-Approval Interventional Studies; Pedro Barroso Inácio, Manager, Regulatory Affairs; Martin Parkinson, Executive Director, Value and Access Consulting, Evidera Inc; and Grace Fattal (moderator), Director, Hematology Oncology, Project Delivery, for the live webinar on Tuesday, November 7, 2023, at 10am EST (4pm CET/EU-Central).
For more information, or to register for this event, visit Data Collection in Continued and Early Access Programs: Value and Utility vs. Challenges.
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