July 27, 2021

Clinical Trials and Surrogate Outcomes (13)

Clinical Trials and Surrogate Outcomes (13)

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...


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

 

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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  

Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence https://www.jmir.org/2020/7/e17571/ 

 

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