As an industry leader in Real World Data (RWD) in compassionate use and managed access programs, digital technologies is an important area of excellence for Early Access Care. We joined the eClinical Forum - a global group of industry peers from Pharmaceutical Companies, Clinical Research Organizations, Clinical Trial Sites, Academia, Technology Providers, and Regulatory Professionals - to continue driving our excellence in cutting edge data issues, new technologies and best practices.
Expanded Access programs can facilitate transitioning patients from a clinical trial or Open Label Extension (OLE) study can pose opportunities and reduce burden to pharmaceutical companies. Because of confusion and misunderstanding of EAPs, in March 2019 the FDA Commissioner Scott Gottlieb MD, Director of FDA's Center for Drug Evaluation and Research, Janet Woodcock MD, and Director of FDA's Center for Biologics Evaluation and Research, Peter Marks MD, issued a statement "Expanded access - Looking Forward". An excerpt from this statement is useful to put EAPs into perspective as a treatment option for Pharmaceutical companies: "..... We are writing to encourage sponsors to offer EA in such circumstances, when continued access to a promising medicine at the completion of a clinical trial would be appropriate under the EA programs."
Last week, at the 2022 Annual Meeting of the American Society for Clinical Oncology a question we were commonly asked was to define an Expanded Access Programs (EAP) and compare and contrast with a compassionate use program (CUP). An EAP allows physicians and patients to access investigational medicines outside of a clinical trial setting.
The term "Compassionate Use" is used by medical professionals to refer to the treatment of a patient with a serious or life-threatening illness with an investigational (unlicensed) medicine. The term is used most commonly when a physician is requesting access for a single patient outside of other company-sponsored programs, like clinical trials, post-trial use protocols, or expanded access programs.
Payors are more open to real world data than ever before. The right drug in the right disease we might be able to demonstrate added supportive information in the real world setting such as an Early Access Program.
We will be attending and presenting, virtually, at many scientific meetings during 2022. Please contact us if you would like to discuss your early access program or other aspects of your company needs, with our Early Access experts. We update this schedule throughout the year.
Early Access Care revisits a comprehensive post on the value of expanded access in the post-trial setting.
We will be attending and presenting, virtually, at many scientific meetings during 2021. Please contact us if you would like to discuss your early access program or other aspects of your company needs, with our Early Access experts. We update this schedule throughout the year.