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:

• Sharing Information and Data: Confidentiality / Non-Disclosure Agreements
• Non-award agreement eGC1 instructions
• Agreement Types

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.

Review the SAGE Advance Budget Overview.

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 WCG IRB 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:

• Do I need IRB Review?
• Is the UW IRB the right IRB?

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.