Quality & Compliance
Safety & Vigilance
05 october 2023
Randomized Clinical Trials (RCT) provide the best evidence of the efficacy of a drug to support regulatory decisions for product approval. RCT overcomes biases encountered in a study, such as selection bias. On the other hand, Real-World Data (RWD) collects data from diversified areas of a patient’s daily life that are outside the scope of RCTs.
The US Food and Drug Administration (USFDA) defines Real-World Data (RWD) and Real-World Evidence (RWE) as follows:
RCT involves predefined selective populations, whereas RWD is a real-world practice. RCTs are usually interventional studies, and RWD is non-interventional.
USFDA defines an interventional study (also referred to as a clinical trial) as a study in which participants, either healthy volunteers or volunteers with the condition or disease being studied, are assigned to one or more interventions according to a study protocol to evaluate the effects of those interventions on subsequent health-related outcomes. On the other hand, a non-interventional study (also called an observational study) is one in which patients receive the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.
The USFDA issued a final guidance for the industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. The guidance outlines the agency’s general expectations for study conduct for non-interventional (observational) studies, which are not subject to FDA’s IND regulations. The salient points are-
The USFDA discusses the applicability of part 312 (Investigational New Drug Application) in guidance to RWD studies.
This guidance is part of a series of guidances that the FDA has already published, or plans to publish, as part of the agency’s RWE program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act.
Conducting and managing Clinical Trials is never a straightforward process. There are subtle nuisances and complex regulations based on your product, the treated disease, the population’s reaction, the regulatory governing body, and many other factors. Many companies and their medicines being developed require an overarching and highly detailed objective analysis for the development and the market approach. Utilizing this premise, ProductLife Group has gathered Clinical and Non-Clinical experts with over forty years of experience in the industry. They have worked from simple generics to complex new chemical and biological entities. They have supported the management of Clinical Trials and attended Scientific Advice and Type C meetings with clients to gain clarification on development protocols. They are eager to take on new challenges, and your project will be the next successful case; whether you are conducting Decentralized Clinical Trials or utilized RWD/RWE information, consider PLG as your partner.
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