Pharmaceutical companies are part of an industry indispensable to the survival of the human species – the health industry. They’re also big business, especially considering the billions of dollars spent on research, innovation, and development of products in this space. We’re taking a look at the changing nature of clinical trials and diving into how they are conducted, reported, regulated, and any compliance issues that might arise.
Joining Michael Cohen for this conversation is the Chief Strategy Office at TrialScope, Thomas Wicks. Thomas has over 18 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling, and submissions management and has been on the PharmaCM team since 2007.
What We Discussed in this Episode:
- How are clinical trial results harmonized and regulated uniformly given various industries in every country run trials?
- What do clinical trials and research entail?
- What is a Phase I trial and what is being measured during this phase?
- What do researches look for in Phase II and Phase III studies?
- Once a product makes it through the first three phases of research and study, what happens next?
- In what form are clinical trial results presented?
- Why was there a shift towards greater transparency in disclosures of pharmaceutical studies?
- How are European countries helping academic researchers?
- What type of information is required to be disclosed? Does it vary by type of company?
- With the coronavirus still spreading, how many clinical trials have been or are being conducted? What are the trials testing?
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