028 Dr. Robert Temple: Clinical Trials: what they are and why they are important

Nov 6, 2019

Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). 

  

In this episode, Therese Markow and Dr. Robert Temple discuss what the term clinical trial means and how it compares to clinical studies or clinical investigations, as well as the many various facets of applying for and conducting a clinical trial. All clinical trials must be approved through the FDA application process and, once completed, the results must be reported back to the FDA. As new drugs and other therapies have been developed clinical trials became more relevant throughout the 20th century.  They discuss how a positive outcome of a clinical trial is determined, namely that there is an improvement in the particular condition being targeted and that there are no harmful effects.   

  

 Key Takeaways:  

• While the FDA recognizes several types of clinical trials, the most common is where there are two groups of patients.  One group receives the therapy in question and the other a placebo or blank.  The participants are not aware of which group they are in. 
• Many clinical trials are completed in a clinic, however, some are now being offered in situ – wherever the participant is already, such as via cell phone. 
• If you are looking at participating in a clinical trial, ask what the data is that they are trying to get from the trial. Ask for what has previously been tried, with animal trials and human trials, with the drug previously. 

   

"That’s what I hope will be conveyed to people – you should be in trials because it’s good for everybody, we learn more." —  Dr. Robert Temple 

     

Connect with Dr. Robert Temple:  

FDA Bio: Robert Temple M.D. 

  

  

Connect with Therese:  

Website:   www.criticallyspeaking.net 

Twitter: @CritiSpeak  

Email: [e-mail] 

  

   

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