Study Data Exchange Standards for Study Data Submitted to the Center for Veterinary Medicine/U.S. Food and Drug Administration

By: Rob Hunter, Animal Health Lead Instructor and Advisor on the topic of animal health regulatory affairs

So, what are data exchange standards? And, why is Center for Veterinary Medicine (CVM) and the U.S. Food and Drug Administration (FDA) requesting input regarding them? Well, on the Center for Drug Evaluation and Research – or CDER – and Center for Biologics Evaluation and Research — CBER — sides of FDA, there are currently two data standards in place, one for clinical data (CDISC) and another for non-clinical data (SEND). A list of CDER and CBER reporting standards can be found here https://www.fda.gov/media/85137/download 

In recent history, CVM/FDA has made the requirement/move to all digital submissions for both NADA and ANADA information to support new drug approvals with the requirement that they be in PDF format for reports and XML for data. This request for comments regarding additional standards is of interest to the industry for many reasons.  As a company or individual, if you have comments or interests regarding this topic, I urge you to submit those to https://www.regulations.gov/ by September 13, 2021, so that they can be considered by CVM/FDA.

I only became aware of the SEND standard recently due to work I was doing for a client and the study was going to be used for a FDA human product submission.  The CRO asked if it had to be in SEND format. Naïve me said, yes, I will need to “send” it to FDA but would need it in an appropriate format. I was then told what they meant and why. Okay, put it in the SEND format since that is what FDA would want. Then, a few weeks later, I saw this request for comments regarding the same format for CVM submissions.  My initial thought was GREAT, we can get a uniform standard and have everyone do the same.  Then, I started thinking about the CROs I work with in Animal Health and the clinics I have and will use for clinical trials. I want to lay out what I think are the pros and cons of both SEND and CDISC implementation in CVM studies and data.

Regarding SEND, this would apply to sponsors and CROs that conduct Target Animal Safety Studies (TASS), Bioequivalence Studies (BE), and all the studies associated with a Human Food Safety technical section, which are all GLP studies.  For dog and cat TASS and BE studies, often the CROs contracted for this work are also conducting pre-clinical toxicology work for human applications, so they would already have the capability to implement the SEND standard, but those CROs devoted solely to animal health would not, leading to possible shift in business and a significant reduction in options as to where to conduct these studies. When you consider the CROs conducting equine, bovine, porcine and poultry TASS, BE, and HFS studies, they currently don’t operate using this standard and, due to their relatively small size, would likely have to incur significant IT costs to implement.  This could lead to problems with two different standards if SEND is only implemented for companion animal studies and not all studies.  I am also concerned, not knowing a lot about this data standard, how terminology that is standard for pre-clinical toxicology studies would fit with CVM/FDA TASS, BE, and HFS studies. 

The CDISC standard is of even greater concern to me. Having worked on several clinical programs in Animal Health over the recent years, implementing Electronic Data Capture (EDC) systems has, at times, been highly problematic. Many clinics do not want their clinic intranet connected to the Worldwide Web, which is just one problem. When you compare the size of the clinical programs conducted for CVM to either CDER or CBER, animal health studies can be more than 2 orders of magnitude smaller than their human counter parts, in smaller clinics with even less resources to implement, review, and maintain the associated systems and standards. 

Should CVM/FDA move forward with implementing these standards, I think it is very likely that the impact on many CROs and clinics will be devastating and have a very profound effect on our industry.  I believe more people, besides just the sponsors, such as the animal health CROs and clinical study sites, need to be at the table with CVM/FDA to discuss why this is being implemented, what the associated costs are (if any), and how it improves data quality, study review times, and product approval times.

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