UW Research

Industry Clinical Trials

Contents

Industry Sponsored Clinical Trial:

A human subjects research study whose primary purpose is to assess the safety and/or efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting.

Clinical Drug Trial Phases

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

Other: A study that does not fall into Phase I-IV definition. Examples include Expanded access, compassionate use, and humanitarian use studies.

Generally, industry sponsored clinical trials are funded by pharmaceutical companies and are based on its protocol. Often, these sponsors work with Contract Research Organizations (CROs) that act as a representative for the company.

When the protocol is developed by the investigator, the clinical trial is referred to as “Investigator-initiated”, regardless of funding source.

Pre-Clinical Trial Confidentiality: Sharing Information

Most clinical trial sponsors require a confidentiality agreement (CDA) before sharing protocols or other proprietary information. Review more on CDAs in Sharing Information and Data: Confidentiality Agreements / Non-Disclosure Agreements.

When asked to enter into a pre-clinical trial CDA, route a Non-Award Agreement eGC1 with the CDA attached to OSP for review and signature. Follow the NAA eGC1 instructions.

If you need a confidentiality agreement, review the UW Approved Mutual NDA Sample Template. Using a UW approved agreement can speed up OSPs review process.

Review more information:

Clinical Trial Agreement

Submit the following documents on an eGC1 in SAGE and route to the Office of Sponsored Programs (OSP):

  • Draft clinical trial agreement
  • Draft clinical trial protocol
  • Draft informed consent form (if available)
  • Sponsor/CRO contact information

If this information is not complete on the eGC1, the agreement will be delayed until OSP receives them.

The UW has Master Clinical Trial Agreements with many pharmaceutical and medical device companies conducting clinical trial research.

Clinical Trial Budget

Clinical trial budgets are reviewed by the UW Clinical Research Budget and Billing (CRBB). Once reviewed, CRBB sends approval to the PI and OSP.

In all cases, industry sponsored clinical trials use the industry sponsored clinical trial facilities & administration (F&A) rate.

Your project may be eligible for an Advance Budget Number while waiting for the contract or budget review to be finalized.

Please use the Advance Budget Number Eligibility Tool.

IRB review

Industry-sponsored and industry-initiated human subjects research conducted by UW researchers is usually reviewed by one of the following Institutional Review Boards (IRBs):

  • An independent IRB such as WIRB or Advarra
  • The Cancer Consortium IRB (CC-IRB) operated by Fred Hutchinson Cancer Research Center (FHCRC)

IRB review fees and an HSD administrative fee may need to be included in the budget. See HSD’s website for more information about IRB review of industry sponsored research.
More information from the Human Subjects division:

Master Clinical Trial Agreements

The Office of Sponsored Programs has Master Clinical Trial Agreements with many pharmaceutical and medical device companies that conduct clinical trial research, including almost all of the major sponsors.

List of Master Clinical Trial Agreements (MCTA)

Review the list

Company Expiration
Abbvie Inc. 3-Aug-20
Abiomed None
ACCRU None
Actelion None
Alkermes, Inc. 23-Sep-26
Amgen None
Astellas 31-Dec-22
AstraZeneca None
Bayer Healthcare Pharma, Inc. 25-Feb-20
Biogen Idec None
Boehringer 4-Apr-22
Bristol Myers Squibb 31-Dec-18
Bristol Myers Squibb Medical Imaging None
Celgene 21-Feb-22
Clovis Oncology None
Cochlear Americas None
Edwards Lifesciences, LLC None
Eisai Medical Research, Inc. 22-Sep-19
Eli Lilly and Company None
EMD Serono, Inc. None
Emergent Product Development 9-Dec-19
General Electric Co. (Comp. Research) None
Genzyme Corporation None
Hoffman-LaRoche, Inc. None
Hoosier Oncology None
Intermune None
Jaeb Center for Health Research 31-Dec-18
Janssen Research & Development 18-Nov-18
MacroGenics, Inc. 19-Jul-21
Medtronic, Inc. 12-May-21
Merck None
Millennium Pharmaceuticals None
Neonc Technologies 15-Apr-21
Novartis Pharmaceuticals Corp. 20-Apr-20
Novo Nordisk None
Pfizer 1-Mar-22
Pharmacyclics, Inc. None
Roche Laboratories None
Sanofi-Aventis 6-Aug-19
SC Liver Research Consortium  None
Seattle Genetics 22-Jul-22
Translational Breast Cancer Research
Consortium Master Member Agreement
30-Jun-21
Vertex  None

** Master CTAs through the Prostate Cancer Clinical Trial Consortium, for members only.

Company Expiration
Algeta ASA ** None
Aragon ** None
BMS (PI-initiated trials only) ** None
Hollis-Eden ** None
ImaginAb, Inc. ** None
Kinex Pharmaceuticals ** None
Medivation ** None
Sanofil ** None