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Instructions for PCF Clinical Attachment for Proposals

March 6, 2007


All sponsored activities (including research, instruction, service, clinical research, and clinical trials/drug/device studies) must be submitted to the Office of Grants Management  (OGM) or Office of Industry Contracts (OIC) for approval prior to submission to the sponsor.

When questions 5 a, b, or c on the PCF are answered yes, the PCF Clinical Attachment for Proposals form is needed.  The PCF Clinical Attachment for Proposals form should be attached to the PCF and accompanying documents.

Question 5 on the PCF:
5. a. Is this proposal for a CLINICAL TRIAL/DEVICE/DRUG STUDY?    No  Yes 
 b. Will this proposal involve affiliated hospital sites or other external health care providers?  No  Yes 
 c. Will this proposal involve specimens, tissues or personally identifiable (not de-identified as defined by HIPAA) data/information (“human materials”)    No  Yes

1. If you have a tracking number assigned to the proposal, include it in the header.  If not, this will be added by OGM or OIC upon entry of the proposal into PeopleSoft.

2. Under each column group (e.g. Initiator of study, Author of protocol) check all the categories that apply.  In most situations, only one box per column group will be checked; however, it is possible that more than one item per column group is applicable.  If Other is checked, describe in underlined space to the right of “Other.”

Cooperative groups are informal and formal network/groups of individuals/organizations that work together on clinical studies.  They may work on common protocols at multiple entities. Examples of cooperative groups are:  SWOG – SouthWest Oncology Group, PPRU – Pediatric Pharmacology Research Unit network.

3. If PCF question 5 c (also listed above) was checked yes, the next section is to be completed.
“De-identification” is a term defined in the HIPAA regulations.  Removal of personally identifiable information may not be de-identification.

4. If PCF either question 5a or 5b was answered yes, the remainder of the form is to be completed.

5. Compassionate use:
Compassionate use: Term used in the US for a method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.

Source:  Medicine Net.com Definition of medical terms http://www.medterms.com/script/main/art.asp?articlekey=30711

The following description of “compassionate use” will assist you in answering “yes” or “no.”

“A formal compassionate use program is a mechanism for getting an unapproved but promising new treatment to patients who would otherwise be unable to receive it. Compassionate use programs are for people who have a life threatening with "no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population" (in the words of the FDA regulations).


Formal compassionate use is a bit like a clinical trial in that you will still have to meet specific requirements such as the type and stage of disease, and usually you must be treated by doctors who participated in the clinical trials for the drug, but compared to trials, the requirements are somewhat relaxed. If you qualify for an open clinical trial of the treatment, obtaining it through compassionate use is not an option.


According to the FDA regulations, compassionate use programs are normally for drugs which are in phase III or have completed accrual to their trials (it takes significant time to allow the data to mature, compile it, and get it reviewed by FDA - often several years), but the regulations do say compassionate use might be possible for some drugs which are only in phase II testing. I presume there would still have to be applicable promising results - such as spectacular results from an ongoing phase II trial. You won't find compassionate use programs for drugs which are in the very early stages of testing. If you just heard about the latest cancer cure for mice on the nightly news, you can be sure there will not be a compassionate use program. There have to be results in people with your type of cancer.

Although the FDA has to approve compassionate use programs, they normally do so without fuss. Whether there is a compassionate use program largely depends on whether the drug company has decided to have one. The decision depends on many factors including the cost which can easily run into the millions and whether there is an adequate supply of the drug (which is often an issue).

Source: Off-Protocol: Getting New Treatments Outside a Clinical Trial found at http://cancerguide.org/offprotocol.html

6. FDA Phase:
For most industry sponsored clinical trials the sponsor will have identified the FDA phase of the study.

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Source: ClinicalTrials.gov Glossary, http://clinicaltrials.gov/ct/info/glossary 

7. Drug/Device FDA approved for Indication:
See Center for Drug Evaluation and Research (CDER) for drugs:
    http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm
    
See FDA Center for Devices and Radiological Health for devices:
    http://www.fda.gov/cdrh/devadvice/index.html 
  
8. Multi-center study:   
Check yes if study will be conducted at other institutions/organizations than the University of Louisville.  Having a clinical trial agreement with ULRF which has the principal investigator seeing subjects at Norton, University Hospital and/or Jewish is not multi-center.

9. Indicate the entities at which subjects will be seen, facilities will be used or resources will be used/provided.  While you do not want to check locations you won’t use, you should include those at which you foresee a reasonable likelihood that you will use or you will enroll subjects for the study.

10. Expected Start Date/Expected End Date:  Provide your best estimate as to the planned start and end dates for this study.  This helps the CRS division know the anticipated schedule.

11. This question addresses the “Rule of 50” option in the HIPAA regulations.  If you expect to see more than 50 subjects at any particular entity (not collectively 50 at all locations), check the appropriate box. If you meet this rule, the requirements for accounting for access to protected health information are simplified.  See HIPAA regulations  § 164.528 (b) (4) (i) for details.

12. If the sponsor of the Study is using a Clinical or Coordinating Research Organization (CRO) (e.g. Quintiles, PPD) provide the name of the contact at the CRO as well as the CRO name and address information.

13. Provide the name and contact information of the individual who is either the “clinical” contact on the study such as the clinical coordinator or the individual handling the regulatory aspects of the study.

If you have any question about the items on the PCF with Clinical Attachment for Proposals, please call the appropriate Office of Grants Management or Industry Contracts.


03/06/07

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