A Rundown on NEW Updates of FDA's Clinical Trial Data Submission Guidelines

In October 2017, an updated version of the FDA’s Technical Conformance Guide (TCG) was released.  The TCG has been around for about 4 years and provides recommendations on how to submit clinical trial study data to the FDA.  Although, this guide is non-binding the FDA emphasizes that adherence to this protocol facilitates drug review and (potential) approval.  On a regular basis, usually every six months, a team of medical professionals, statistics/data reviewers and technical staff meet to discuss recent clinical trial study data submissions and associated problems.  These discussions lead to an implementation of necessary updates to the TCG that will help guide those interested in a seamless FDA drug approval process. 

Needless-to-say, there is a lot of information in this guide and it does drum up many questions, so we wanted to provide a brief rundown on the main update and its takeaways.

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Patient Recorded Outcome (PROs) Data Standard Update

Clinical outcomes of a drug in trial can be made by a patient, a doctor, an observer, or a task performed by the patient and measured by a health professional.  Lately, there has been a large emphasis on Patient Recorded Outcome (PROs) - a measurement based on a report from a patient – to facilitate a more patient centric approach to drug development.  In fact, the incorporation of the patient voice in drug development and decision making was just re-signed into law as of Aug 18, 2017 (see Prescription Drug User Fee Act ).  

As beneficial as patient information is, the FDA has found that there is quite a bit of missing values, or ‘logically skipped items’ from patient completed assessments.  These missing values introduce bias and ultimately interfere with the ability to compare effects and the patient groups may no longer be comparable.

In the latest version of the TCG, they have defined and updated recommendations of how to create data standards for the logically skipped items in PROs so your study data will be well-defined, reliable and traceable. For the complete guide for Patient-Reported Outcome Measures, click here.  

 

The Top 4 Takeaways

The specifics of the standards are beyond the scope of this blog and of course, each clinical trial is different, so it’s best to work with an FDA advisor or CRO to develop the best data standardization processes for your needs.  For a brief rundown, we’ve listed the top four takeaways from the new TCG on this subject. 

  1. PROs have become a key part of clinical trial data submissions and an increasing number of drug submissions use PROs for efficacy in primary and secondary endpoints.
  2. During standardization protocol development, it’s necessary to be able to distinguish between truly missing values from those that are logically skipped.
  3. Once your data values are clearly defined, work with your FDA representative to create standards to identify, segment and organize logically skipped items in your PROs.
  4. All your well-defined and reliable data should be included in submissions to the FDA but don’t send non-standardized data unless it’s requested.
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