Steps in the Submission of Clinical Proposals

What is a clinical trial?

An organized testing of new investigational drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions and/or other outcomes, if any, in human subjects. These trials range from single-site investigator-initiated studies to multicenter cooperative trials. Any of these trials may involve obtaining an investigational new drug (IND) or investigational device exemption (IDE) approval from FDA.

What are the phases of clinical trials?

PHASES OF CLINICAL TRIALS
	I	II	III	IV
	Pre-marketing			Post-marketing
Length of Study	1 week to several years	Several months to 2 years	Several months to 4 years	Several months to several years
Number ofÊ Subjects	10 to 100	50 to several hundred	Several hundred to several thousand	50 to several thousand
Purposes	Determine pharmacology, pharmacokinetics, toxicity and safe dosage in humans	Determine safety and efficacy in a limited number of patients	Compare safety and clinical effectiveness of drug to standard therapy in a large population	Provide additional information on the efficacy or safety profile

I have an idea for a clinical trial. Now what do I do?

Discuss your idea with clinical and basic investigators who are interested in a similar patient group or clinical problem to refine your hypothesis.
Contact a potential sponsor to determine their interest in your ideas.
Determine your ability to recruit subjects. This is tough but important.
Utilize campus and hospital resources. The offices described in this brochure are designed to facilitate your research.

Where do I find out about sponsors?

Federal and Foundation Sponsors:

Use these Internet databases:
Community of Science
Illinois Researcher Information Service (IRIS)
Sponsored Program Information Network (SPIN)
Contact Sandi Robins to receive funding notices in your research area.

Industrial Sponsors:

Utilize resources:

Other UW faculty.
Industry publications, i.e., Monthly Prescribing Reference, CenterWatch and Clinical Investigator's Directory.

Contact the Clinical Trials Office (CTO).
If cancer-related, contact the Clinical Trials Research Office (CTRO) of the University of Wisconsin Comprehensive Cancer Center (UWCCC).

What can department and school research offices do for me?

Department administrators or school research administration offices can:

Help PIs prepare budgets.
Check all federally required certifications.
Help non-tenure track staff obtain project PI status.
Approve the submission of proposals to facilitate the approval process. All proposals for extramural funding (including Confidentiality Agreements, Material Transfers and Clinical Trial Agreements) must be accompanied by a University Extramural Support Transmittal Form (T-Form).

What can the Clinical Trials Office (CTO) do for me?

CTO is a full-service resource that:

Maintains a master list for all hospital charges (e.g., laboratory tests, supplies, procedures, radiology).
Formulates and reviews clinical trial budgets.
Helps prepare and submit applications for Human Subjects Committee, GCRC, Veterans Administration Hospital (VAH), for INDs and IDEs, and other FDA documents.

What can the Clinical Trials Research Office (CTRO) of the UWCCC do for me?

The National Cancer Institute (NCI) requires all cancer-related trials to be reviewed by this Office within the UWCCC. This office:

Advises on subject recruitment, design, and staffing of clinical trials involving patients with cancer.
Aids in the preparation and scientific review of cancer protocols.
Provides statistical services.
Is a conduit to Eastern Cooperative Oncology Group (ECOG), other cooperative groups and NCI funding.

What can Investigational Drug Service (IDS) do for me?

All human clinical drug studies conducted at UW must be registered with IDS. The IDS staff can:

Determine drug and/or pharmacy related costs in clinical trials.
Provide profiles of available patient populations.
Ensure compliance with federal, state and University regulations and guidelines.
Serve as a contact with investigators experienced in outcomes research and clinical pharmacotherapy.

What can the General Clinical Research Center (GCRC) do for me?

The General Clinical Research Center (GCRC) is one of 73 NIH-funded centers in the United States. It can provide you with:

Inpatient and outpatient rooms for patients on approved trials.
A facility for computerized data management and analysis.
Support personnel (e.g., nurses, dietitians, computer systems manager, biostatisticans).
A sample processing facility and supplies.

Your application for use of these facilities must be reviewed by the GCRC Review Committee. Application materials are available at the GCRC.

What can the Health Sciences Human Subjects Office (HSO) do for me?

Review of all research involving human subjects is federally mandated. The Human Subjects Office will help you meet federal requirements. The staff can:

Discuss issues in protecting human subjects that are relevant to your research.
Pre-review a draft of your research protocol and the subject consent form to identify potential problem areas and suggest ways to address them before the Human Subjects Committee (HSC) review.
Provide HSC guidelines and research protocol submission forms.

Who else can help me to comply with federal regulations?

The following offices provide training and resource materials and ensure compliance with various regulations:

Animal Care Unit in the Health Sciences: Denver Marlow.......................262-3009
Biological Safety: Joe Kanabrocki...................263-2037
Occupational Health: Carla Alvarado...................263-2177
Radiation Safety: Ronald Bresell...................263-9178

REFERENCES:

Brochures on submission of proposals, involvement of human subjects, safety, patents and copyrights and research ethics are available in departmental and college research administration offices and on the Internet at Research Services Guides.
Documents entitled Clinical Trials Agreement and Clinical Trials Handbook are available on the Internet at Clinical Trials.

RESOURCES:

COLLEGE RESEARCH ADMINISTRATORS:

Medical School:

Jack Graham......................263-4940
jlgraham@facstaff.wisc.edu

Sandi Robins.....................263-5978
srrobins@facstaff.wisc.edu

School of Nursing:

Colleen Bindley..................263-5289
cbindley@facstaff.wisc.edu

School of Pharmacy:

Tim Gossens......................262-9984
tjg@pharmacy.wisc.edu

ASSOCIATE DEANS FOR RESEARCH:

School of Medicine:

Paul M. DeLuca, Jr...............265-0523

School of Nursing:

Susan Riesch.....................263-5180

School of Pharmacy:

William Mellon...................262-1200

FOR MORE INFORMATION:

Clinical Trials Office

Tesheia Johnson.................262-9398
tjohnson2@facstaff.wisc.edu

Clinical Trials Research Office of UWCCC.....263-8403

General Clinical Research Center

Paul Reichel.....................263-3271
preichel@facstaff.wisc.edu

Health Sciences Human Subjects Office

Shelley Lagally..................263-2362
sml@medicine.wisc.edu

Investigational Drug Service

Rebecca Marnocha.................263-8902
rm.marnocha@hosp.wisc.edu

Cancer Tumor Registry

Judy Howells.....................263-1090
judith.howells.@uwmsg.hosp.wisc.edu

Updated August 1999

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