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Regarding the FDA topics in this forum, it is crucial to note that research endeavors for real world data projects can\’t replace certain traditional studies. Analyses of some observations can\’t always substitute for studies in certain ways. For example, animal studies can show results for toxicological issues that may be difficult to study in human subjects. Some of these areas include: developmental, chronic and reproductive issues.
The FDA does believe that RWD can be collected and analyzed utilizing rigorous methods, and can therefore be important in advancing the science of CBD. This advancement can be accomplished by assisting with generating hypotheses and by streamlining the design of follow up studies. RWD can identify new, potential adverse effects and can also define subgroups of CBD users who should be the concentration and basis for follow up studies.
In order for the collection of CBD data to have the greatest scientific impact, the data should address the most crucial and scientific challenges in this CBD field.
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