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25 Years | 25 Stories of NAVREF
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25 Years | 25 Stories of NAVREF
Since 1992, the National Association of Veterans' Research and Education Foundations has worked to support our members to become a source of excellence for VA Research and Development. Over the course of Fiscal Year 2017, NAVREF will be promoting 25 stories from our members, friends, and stakeholders recounting our unique heritage, culture, and spirit.  You can look forward to 2 recollections each month culminating on September 10th in Las Vegas where we will host our 25th Annual NAVREF Conference.  Thank you for your support of NAVREF’s vision of a nation in which veterans receive the finest care based on innovative research and education.

Our Sixth Story: CRADA RevDev

Dave Johnson
Executive Director at the Baltimore Research and Education Foundation in Baltimore, MD since 1990.

I have recently experienced a miracle; execution of a clinical trial Cooperative Research and Development Agreement (CRADA) with only having to negotiate the budget.  Having CRADAs that are accepted by industry sponsors and easy to implement is vitally important to the clinical studies component of VA-affiliated non-profits (NPCs).  Clinical trials are the sole source of income and activity for some small and midsize NPCs.  NAVREF played a critical role in the development of CRADAs and refinement of the VA CRADA review process.
 
Study agreements for clinical trials in the VA have had an interesting history and have traveled on often bumpy roads.  Before NPCs were established, agreements for clinical research studies conducted at VA were mostly agreements between the study sponsor and the academic affiliate.  Occasionally, study agreements were made between VA and the study sponsor and study-related funds were deposited in the VA’s General Post Fund account.  Although that was a relatively unusual way to use General Post Funds, it was successful in getting funding into the VA to cover study expenses.  Interestingly, that mechanism is theoretically still available for small VA Medical Centers who have only an occasional need to participate in industry-sponsored clinical trials.  

Soon after NPCs were established (title 38 §§ 7361 through 7366, United States Code) clinical trial study agreement between VA and the study sponsor were mostly in the format pharmaceutical industry sponsors used for study agreements funded through the academic affiliates with a few VA-centric phrases added.  That format continued for several years until VA General Counsel’s Office determined that the Federal Technology Transfer Act of 1986 (15 U.S.C. § 3710a, et seq.) and the execution of CRADAs was the only authority available for VA to enter into agreements with industry study sponsors.  

Development of CRADAs was assigned to The CRADA Study Group at VA Central Office and Barbara West, in her role as NAVREF Executive Director, suggested that NAVREF and NPCs be represented on the committee along with VA General Counsel office representatives.  The internal negotiations for the development of the first CRADAs were long and spirited but the committee finally developed CRADAs it felt were sensitive to the needs of both VA and industry sponsors.  Unfortunately, the initial clinical trial CRADA templates were not well received by the pharmaceutical industry resulting in a long period of time when clinical trial agreements were not executed in the VA.

NAVREF and its members initiated educational programs designed to explain CRADAs to pharmaceutical industry representatives and convince them that CRADAs were similar to the study agreements they had traditionally executed with medical schools.  Invitations were issued for pharmaceutical representatives to attend NAVREF annual conferences, special NAVREF-sponsored conferences and NAVREF and its members attended numerous pharmaceutical industry conferences where CRADA training was also presented.  The training was successful and resulted in CRADAs being executed for clinical trials conducted at VA medical centers.  

Initially, CRADAs were reviewed and approved by attorneys in VA Regional Counsel offices.  Since those attorneys had many other duties, review of CRADAs were not their top priority and, consequently, the review process was slow.  At NAVREF’s suggestion, a group of Regional Counsel attorneys was assembled who were given the responsibility of reviewing CRADAs from medical centers in their region.  NAVREF continued to encourage for a more efficient CRADA review system resulting in the establishment of the Specialty Team Advising Research (STAR) in General Counsel’s Office and Maryam Azarion is to be congratulated for putting together a team of VA attorneys that has become very efficient in reviewing CRADAs. 

Dr. Jeff Moore, in his role in the VA Technology Transfer Office, developed master CRADAs with a number of pharmaceutical companies which alleviated the need to negotiate a CRADA for each clinical trial.  The master CRADA format has evolved into multicenter CRADAs which are easier to negotiate with the industry sponsor and execution at the individual medical centers participating in the multi-site clinical trial only have to negotiate the individual site budget with the sponsor.  The CRADA I recently helped execute is a multicenter CRADA. 

Without the expert input of NAVREF and its members, we would not have CRADAs with the level of acceptance they enjoy today nor would we have very efficient CRADA reviews by VA attorneys.  Negotiations for single site CRADAs are frequently completed within a month and delays in completion of the negotiations are frequently due to industry delays.  NAVREF continues to provide clinical study support to its members.  We are fortunate that Rick Starrs picked up the NAVREF leadership baton and is continuing the NAVREF tradition by making it easier for NAVREF members to identify and participate in new industry-funded clinical trials.  

Congratulations to NAVREF for its 25 years of providing support for its members and for the critical role it played in the development of CRADAs, the vehicle for providing state-of-the-art medical care for VA patients.
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