Clinical Trials & Surrogate Outcomes

Looking for clinical relevance means looking for a lot of details. 

A crucial part of that is looking at WHAT is compared with WHAT

But what if a comparison is not clinically relevant  - what do you do then?

And how about studies using surrogate outcomes perhaps even approved by the FDA - they must be clinically relevant - but are they?

In this episode, we talk about how to navigate this and find the best available research

You don’t want to miss this episode

 Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z  

LINKS:

Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines Supplemental content, JAMA Oncology (2017) https://jamanetwork.com/journals/jamaoncology/fullarticle/2594542 

FDA Approved Surrogate Endpoints: https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure  

NOTES: 

• Finding clinically relevance in what is compared with what in a clinical trial 
• How can we know what a relevant comparison is?
• Different kinds of comparisons in clinical research
• The pro and cons of surrogate endpoints
• Examples of surrogate endpoints you should avoid
• Outcomes in oncology research
• FDA rules
• When is information from placebo trials relevant - and when isn’t it relevant
• Research with no comparator, when can that be useful?

GET THE ABSTRACT SCREENING TOOL

It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool to use when reading an abstract from a clinical research paper.

Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com 

Contact us at email: podcast@precision-evidence.com,

Twitter @PrecisionEBM,

You can learn more at our website, where you can also leave us a voice message.

Website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD   &  https://www.linkedin.com/in/kim-kristiansen 

JG Staal: @HealthyEvidence

 Music thanks to mixkit.co