Industry Clinical Trials
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.
- 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.
Most clinical trial sponsors require a confidentiality agreement (CDA) to be in place before sharing protocols or other proprietary information. When asked to enter into a CDA, forward the CDA to email@example.com for review and signature.
An investigator who signs a CDA is exposed to potential personal liabilities and if something goes wrong, the UW will not be obligated to provide representation. If an investigator wishes to enter into the CDA due to urgent circumstances, they may do so, but strictly in a personal capacity.
Some factors to consider:
- The investigator does not have authority to enter into a CDA on behalf of the UW.
- Length of the obligation to keep the information confidential should be reasonable e.g. 5 years is typical.
- Term (effective dates) of the CDA itself does not need to be longer than a year. The CDA term is different than the confidentiality period.
- Scope of the CDA should cover only a single named clinical trial, protocol or drug, not possible future studies.
- The sponsor should be required to mark or clearly designate confidential information.
- These types of information must be listed as exceptions in the CDA:
- Information already known by the researcher,
- publicly available information,
- Information independently developed by the researcher.
- There is no transfer Intellectual Property (IP) rights from the researcher or UW to the company.
- The CDA should not indicate an exclusive relationship with the company.
Submit these 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 UW Clinical Research Budget and Billing (CRBB). Once reviewed, CRBB sends approval to the PI and OSP. In all cases, industry sponsored clinical trial 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.
Clinical trials conducted by UW researchers are usually reviewed by one of the following Institutional Review Boards (IRBs):
- Western Institutional Review Board (WIRB) reviews most industry-sponsored and industry-initiated trials conducted by UW faculty. Industry-initiated means that the sponsor writes and owns the protocol for the study. IRB review fees and an HSD administrative fee must be included in the budget.
- The Cancer Consortium IRB (CC-IRB) reviews most oncology trials conducted by UW faculty who are members of the Cancer Consortium.
The UW IRBs review federally-funded and/or investigator-initiated clinical trials.
The Office of Sponsored Programs has entered into Master Clinical Trial Agreements with a large number of pharmaceutical and medical device companies conducting clinical trial research, including almost all of the major sponsors.
Master Clinical Trial Agreement List
|Bayer Healthcare Pharma, Inc.||25-Feb-20|
|Bristol Myers Squibb||31-Dec-18|
|Bristol Myers Squibb Medical Imaging||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|
|Jaeb Center for Health Research||31-Dec-18|
|Janssen Research & Development||18-Nov-18|
|Novartis Pharmaceuticals Corp.||20-Apr-20|
|SC Liver Research Consortium||None|
|Translational Breast Cancer Research
Consortium Master Member Agreement
** Master CTAs through the Prostate Cancer Clinical Trial Consortium, for members only.
|Algeta ASA **||None|
|BMS (PI-initiated trials only) **||None|
|ImaginAb, Inc. **||None|
|Kinex Pharmaceuticals **||None|
Forms, Tools, and Resources
- Human Subjects Division (HSD)
- UW Advancement: Working with Corporations
- UW Business and Industry
- UW Medicine Clinical Research Budget and Billing (CRBB)
- Institutional Facts & Rates
- ClinicalTrials.gov Registration
- SAGE: eGC1 Overview
- Set Up: Industry Clinical Trials
- Clinical Research Handbook
- Office of Sponsored Programs
- Pre-Clinical Trial Nondisclosure Agreement (NDA)