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GCRC at University of Washington Medical Center

Kathy Long
Administrative Manager
(206) 598-4700
gcrc@u.washington.edu

Pediatric CRC at Children's Hospital and Regional Medical Center

Charla Jones
Administrative Assistant
(206) 987-2385
PediatricCRC@seattlechildrens.org

Industry-Sponsored Studies

• GCRC priorities
• Special cases
• How to apply

Industry Study Billing Policies
GCRC (pending)
Pediatric CRC (rev. Aug. 2004)

GCRC priorities The priority of the GCRC is to conduct investigator initiated studies, designated "Category A", whose funding sources are from non-profit organizations such as the NIH. However, the GCRC can be used for industry sponsored studies. Industry sponsored studies are designated "Category D" and the for-profit organization sponsoring the study is expected to pay for the use of GCRC facilities at the same rates that it would pay for any hospital bed or clinic usage and ancillary charges at University of Washington Medical Center (UWMC) or Children's Hospital and Regional Medical Center (CHRMC). Investigators who are receiving industry support for projects conducted on the GCRC must be free to publish or distribute data from such studies without restriction.

All industry sponsored projects must undergo scientific review and be approved for use on the GCRC by the Scientific Advisory Committee and include a Data and Safety Monitoring Plan or Board per NIH guidelines. Category D studies are considered at a lower priority than investigator initiated studies when evaluating resource utilization in the GCRC, and must be able to schedule subject visits during afternoon or evening hours. Category D studies should constitute only a minority of the GCRC portfolio of protocols.

There are two cases in which industry sponsored studies would be considered as "Category A " studies:

Primarily investigator-
initiated If the industry sponsored study is investigator initiated and only the funding or a critical drug or device for the study is derived from industry. If this is the case, the investigator must supply a letter from the company stating the clinical trial was largely conceived and designed by the investigator.

Rare diseases If the study focuses on a patient population which is considered a "rare disease." Advances in the treatment of rare diseases may not be considered to be commercially viable. To facilitate development of agents for orphan diseases the Orphan Drug Act specifically permits the Secretary of the DHHS to make grants and/or contracts to assist in defraying the costs of qualified clinical testing of drugs, devices, or foods for rare diseases and conditions. Following this lead, the national GCRC Program modified the GCRC research category classification to facilitate testing of new agents for patients with rare diseases. Consequently, clinical trials of drugs and other candidate therapies or interventions for rare diseases may be classified by the local Scientific Advisory Committee as category A, instead of D.

An orphan or rare disease is generally considered to have a prevalence of fewer than 200,000 affected individuals in the United States. Certain diseases with more than 200,000 affected individuals are included, but subpopulations of these conditions may be less than the prevalence standard for rare disease. Your application will need to describe why your study qualifies as an "orphan disease" study.

If you have questions about whether your study would be classified as a Category D study, please call the GCRC administrator at (206) 598-4700 (UW) or (206) 987-2385 (CHRMC). Category D studies will be accepted to be conducted on the GCRC only if the study passes review by the Scientific Advisory Committee at UW or CHRMC and the GCRC has space available for use by commercial entities. Priority use of GCRC resources will always be given to Category A/B studies.

Steps in Applying to use the GCRC for Industry Sponsored Studies

1. Determine whether your study is truly industry sponsored using the above guidance.
2. Contact the GCRC administrator for information concerning the charges for your study (cost of room, nursing, etc.) so that you can formulate your budget.
3. Contact the Research Subject Advocate to determine what type of safety monitoring program you may need to have in your application (e.g. multi-center Phase III studies require a Data and Safety Monitoring Board).
4. Click here for application forms.
5. Supply a letter from the sponsor stating you will be free to publish or distribute data from your study without restriction.
6. Submit application.
7. The Scientific Advisory Committee will review the application, particularly evaluating:
   • Scientific merit
   • Research subject safety
   • Resource utilization, e.g. are resources available for your industry sponsored study at this time

Your study will be either accepted outright, accepted after you respond to questions and suggestions for modifications, tabled due to insufficient information, or not accepted.

If you have any additional questions concerning industry sponsored studies, please contact us.