Real World Data in Expanded Access Protocols
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...
Well-designed clinical trials, remain the best way to assess efficacy and safety of investigational medicinal products. Clinical trials are the gold standard for registration and approval of new medicines
Real World Data (RWD) collection has increasingly become a desired component of early access programs (expanded access, managed access, named patient program) and post-trial access programs.
Data collected through standardized industry-sponsored early access programs may be used to supplement clinical trial data to help inform regulatory decision. Regulatory authorities in Europe, the United Kingdom and the United States consider real world data on a program specific basis.
Several regulatory authorities have made public statements about the acceptability of data collection in MAPs and its use in support of pricing and reimbursement (P&R). There is a goal of collecting any data in a well-designed structured manner, to provide valuable information that is interpretable by regulatory agencies. In Europe, RWD has been used to reduce the P&R timelines in many EU countries, as well as the potential to use data for publication.
Your EAC team is experienced in RWD collection and Early Access Care in-house experts can develop the data collection program to meet your intended need. We use industry best practice and standards when planning data collection.
The following RWD services are available:
Data collected in a well-designed early access program, with experienced data scientists, can provide a valuable opportunity for a pharmaceutical and biopharmaceutical company, such as:
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