A nimble model is transforming the preclinical workspace. Are you ready?
Nearly a decade ago, US regulators adopted the Study Data Tabulation Model (SDTM) to increase the quality and efficiency of its reviews. Developed by the Clinical Data Interchange Standards Consortium (CDISC), SDTM enabled both the Food and Drug Administration (FDA) and industry to use standard-based tools to improve on traditional time-consuming techniques more subject to human error. SDTM also facilitated data pooling for combined analysis or meta-analysis of multiple trials.
The SDTM soon became standard in clinical trials, but its influence on non-clinical data submissions has taken longer. Though a committed group of pharmaceutical and CRO leaders, as well as vendors, joined forces in 2002 to create the Standard for the Exchange of Nonclinical Data (SEND), the submission of nonclinical data in an electronic form was not widespread at that time. Moreover, companies didn’t want to commit resources to SEND until the FDA accepted it.
In 2007, things started looking up for SEND, due in large part to industry support for the model and a renewed interest from the FDA, including its commissioner. SEND now has its own implementation guide called SENDIG for the submission of nonclinical toxicology and pharmacology data. Four years ago, the first SENDIG was issued. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) issued guidance documents late last year that set requirements for the submission of SEND datasets. The SENDIG version, 3.1 is due to be released this year on CDISC’s website.
SEND is one of the biggest initiatives in the drug development industry at this time and will be required for all in scope study and data types in the near future. Getting used to SEND will take time, however. I have been in the Information Technology industry for over two decades-most of that time working on nonclinical data-and I’ve been part of the CDISC SEND team since 2007. So I speak from experience when I say that like any new data management tool, SEND will take time to adjust to and there will be many questions along the way. These are some of the questions I receive the most regarding SEND but feel free to submit your own in the Comments section of this blog.
What is the goal of SEND?
SEND is a standardized format for the entire industry to submit their nonclinical data to the FDA. The goal of SEND is to establish an industry standard in the content and data structure of data submitted in electronic format to the FDA. It will also phase out paper submission to the FDA and improve quality of scientific review by CDER pharmacologists and toxicologists.
What study types are affected by SEND?
Initially, SEND applies to single-dose, repeat-dose and carcinogenicity studies as per SENDIG 3.0. This includes both GLP and non-GLP studies. Safety pharmacology and reproductive toxicology are not included in the current guide, but will soon be in a later version of SEND.
When will SEND compliance be mandatory?
The FDA will mandate studies in SEND format for studies that start after Dec. 17, 2016 within an ANDA/NDA and certain BLA submissions, or studies that start after Dec. 17, 2017 within certain IND submissions. For more details, you can view the Providing Regulatory Submission in Electronic Format-Standardized Study Data Guidance for Industry (December 2014) on the FDA website.
What should sponsors do if they subcontract out a study to multiple CROs but also conduct some of the work inhouse?
Given the shifts in nonclinical research, this is likely to be a common scenario that unfortunately can’t be handled with a one-size-fits-all solution. Vendors/CROs across the industry will have varying capabilities regarding SEND. Some will choose not to invest in SEND capabilities at all. Therefore it is very important to understand your vendor’s/CROs roadmap for SEND so that you can make the best decision for your circumstance. If your vendor can provide SEND datasets, these can be merged into the overall SEND package. Working with your vendors/CROs now to understand their capabilities and solidifying processes will certainly make for a smoother transition once SEND is mandatory.
Will CROs be submitting the SEND data to the FDA?
No. The sponsor is responsible for submitting the data. The Sponsor should have the ability to receive, read, analyze, submit and archive the SEND data provided by the CRO.
Many Sponsors are requesting that studies be SEND-compliant now. Why is this important now if SEND isn’t even mandatory until the end next year?
A lot of sponsors are requesting their current ongoing studies, be SEND-compliant. This is understandable. Many Sponsors are targeting to pilot with the FDA before the end of the year and therefore want as many studies to choose from as possible.
How to cite:
Walker, A., SEND in the Data. Eureka blog. May 28, 2015. Available: http://eureka.criver.com/send-in-the-data/