AIDS TREATMENT NEWS No. 065 - September 23, 1988
John S. James
"To help decide which drugs are the most promising, the NIAID established an AIDS Clinical Drug Development Committee (ACDDC), composed of Government and non-Government experts, to evaluate candidate drugs for entry into NIAID-sponsored clinical trials. The goal of this effort is to ensure than any drug showing scientific promise and receiving a high priority rating by the Committee will be evaluated in a clinical trial. Some concern has been expressed that there may have been undue delays from the point at which the ACDDC designates a drug as "high priority" to its being entered into a clinical trial and patient accrual begun. However, it is important to point out that the initiation of clinical trials with investigational new drugs is often complicated and requires extraordinary coordination among Government, research institutions, and pharmaceutical manufacturers. There are many issues that limit our ability to go rapidly from the designation of a drug as "high priority" to patient accrual into a clinical trial.
"At either the stage of ACDDC review of a drug or the drug's subsequent referral to the AIDS Clinical Trials Group com- mittee, there are often a variety of issues that still may need to be resolved: recommendation for additional safety and effi- cacy studies in animals; extensive negotiations with the manufacturer are often needed to ensure the production of sufficient quantities of clinical grade material prior to the further development of the protocol(s); all supporting preclinical information, manufacturing processes, and intended trial design must be approved by the Food and Drug Administration (FDA); the pharmaceutical manufacturer must agree to supply the drug required to conduct the study as well as agree to the design of the protocol; Institutional Review Boards at the individual medical centers must also review and approve the proposed protocol; case report forms must be designed and reviewed with statistical input to assure that the measurements taken throughout the study are being collected in a manner that will provide the necessary data to meet the predetermined objectives; and finally, patients must be screened in order to select the population that meets the intended protocol entrance criteria. The failure of any one or more of these elements to be accomplished in a timely fashion can cause unforeseen delays in the initiation of the clinical trial."
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