CLINICAL DRUG TRIALS HOW TO WRITE AND SUBMIT by heatherrhunt

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									     C LI NICAL D RUG T RIALS : H OW              TO   W RITE AND S UBMIT .

Clinical Drug Trials at Sir Charles Gairdner Hospital
At SCGH, Clinical Drug Trials are checked for compliance with NH&MRC
Guidelines on Clinical Research and Guidelines on Good Practice in Clinical
Research in a two-step process. Firstly, the trial comes before Clinical Drug Trials
Committee (CDTC), which is an expert committee of clinicians, clinical researchers,
pharmacist and statistician. CDTC makes a judgment on whether the trial will meet its
scientific objectives and identifies any ethical issues that the analysis reveals. It makes
a recommendation to the Human Research Ethics Committee. The Human Research
Ethics Committee is a representative and expert committee, constituted in compliance
with NH&MRC requirements for an ethics committee. It meets after the CDTC. It
issues the final approval and the chairman signs the Clinical Trial Notification (CTN)
form that is sent to the Therapeutic Goods Administration in Canberra.


CDTC Approval Process
Trials that have clear, achievable and ethical objectives move rapidly through CDTC.
In 1999, the median time from submission to CDTC approval was 15 days and the
minimum time was 6 days. However, a minority of trials go through a very laboured
approval process because their protocols fail to inform CDTC that they are ethical and
have achievable objectives. The CDTC will not recommend approval for a trial that
intends to direct staff time, patient time and resources in pursuit of an uncertain,
unachievable or dubiously ethical objective. CDTC undertakes a structured review of
each protocol and classifies it into one of these five groups:
A. Complies with NH&MRC and Good Practice Standards: approve
B. Complies, but needs assessment by statistician. Approved if statistics & design
   sound.
C. Protocol fails to comply, but only in minor areas. Can be approved subject to
   satisfactory amendment.
D. Protocol fails to comply, but only in minor areas. Requires circulation and
   discussion in committee.
E. Fails to comply in significant areas, requires general circulation and discussion in
   committee.
F. Submission does not meet basic requirements for evaluation, as set out in Clinical
   Drug Trials Checklist and Protocol Template: to be returned for completion.
The majority of protocols fall into category A. Protocols rated D or E are
discussed in committee. Protocols rated F are returned to the investigator,
without being placed before the full committee.


Resources for Writing and Checking Trials
This Web site provides the following documents, in Word format, so that you can
write protocols that are valid for their purpose or check that other people's protocols
meet requirements:
1) A template for writing a drug trial protocol from scratch. It includes all the
   components that are general to valid trial protocols, and indicates how to
   complete it. It follows the sequence that the committee reviewer uses. There is a
   short instruction document for it, too.
Download: template           for      writing     a     drug     trial     protocol
[CDTC_Protocol_Template.doc]
              instruction document [CDTC_Template_Checklist_Instructions.doc]

2)  A check list that you can compare with a protocol that is already written, to
   ensure that it will comply.
Download: check list [CDTC_Protocol_Checklist.doc]

3) The assessment form that the CDTC reviewers use. This follows the sequence of
   both the template and the check list. It is available in both paper and electronic
   versions
Download: paper version [CDTC_Assessment_paper.doc]
              electronic version [CDTC_Assessment_electronic.doc].

4) This document
Download: this document. [Clinical Drug Trials Website.doc]


Contacts
CDTC Secretary:
       Richard Donnelly,
       Pharmacy Dept, SCGH
       Tel. (08) 9346 4129
       richard.donnelly@health.wa.gov.au

								
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