“Collective Medical Technologies ... helps providers and payers take better care of their patients using real-time data and collaborative care planning tools”
♫
Said on Relentless Health Value
“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
Meryl Dersarkissian · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
Play from 30:36
30:36
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What was described
Plan real-world evidence prospectively with a pre-specified protocol and statistical analysis plan before data collection
Said nearby on the same subject
“…the plan sponsor owns the data. The plan sponsor must have access to the data… they’ve signed the rights away when they signed the contract.”
FP
Frank Panaccio
Relentless Health Value ·
“Defining the role is easier before the employee starts… Resolving scope is easier before the contract is signed… Planning the project is easier before the crew's mobilized.”
TD
Todd DeWalt
The Construction Leading Edge Podcast ·
“We have real-world evidence, a successful phase three study, and we're going to bring up that NEJM article to the FDA.”
MR
Mark Robbins client
FDA Watch ·
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