Early Access Care is a sponsoring member of the eClinical Forum - a global group of industry peers from Pharmaceutical Companies, Clinical Research Organizations, Clinical Trial Sites, Academia, Technology Providers, and Regulatory Professionals across 53 countries, focusing on systems, processes and roles relevant to cliical research. Early Access Care is driving our excellence in cutting edge data issues, new technologies and best practices and is actively participating in the eClinical Forum discussions.

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.

As internal stakeholders engage in project conversation, they quickly identify potential opportunities to gather additional data during the program. It’s easy to lose focus of the original streamlined base deliverable of an Expanded Access Program. Opportunities for additional data collection are the most common seedlings of scope creep. This brief article helps teams identify some of the common areas of scope creep and how to prevent it in your Early Access Program.

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.

The Senate passed 'right-to-try' legislation on August 3, 2017. The version passed is an updated version of a bill proposed by Sen. Ron Johnson (R-Wis.)...

The 2017 GAO report on Expanded Access is now available. The GAO conducted a survey and interviews amongst pharmaceutical manufacturers...

Anne B. Cropp will be participating in an Expanded Access Summit titled "Integrating Expanded Access into the Drug Development Process...

Anne B. Cropp will be speaking at the Early and Managed Access Programs Europe conference in London, UK - October 24-26, 2017.

A two-part workshop on initiating an early access program, either for individual patients (Single Patient IND; Named Patient) or groups of patients...

Anne Cropp, Pharm.D. was a panelist at the NY School of Medicine / New York Academy of Sciences symposium "The Need to Accelerate Therapeutic Development...

The Reagan-Udall Foundation for the Food and Drug Administration has officially launched the EA Navigator. This is a voluntary directory of pharmaceutical...

Early Access Care enjoyed the opportunity to discuss compassionate use at the Drug Information Association Annual Meeting in Chicago.