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Improvements Needed in Clinical Testing of Anticancer Drugs

HRD-83-52 Published: Sep 26, 1983. Publicly Released: Oct 04, 1983.
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Highlights

In response to a congressional request, GAO reviewed the clinical testing of anticancer drugs and the regulation of that testing by the Food and Drug Administration (FDA) to determine: (1) how well, during its review of new anticancer drug applications, FDA discharges its responsibility to protect human test subjects; (2) the manner in which drug sponsors and institutional review boards carry out their responsibilities; and (3) whether there is therapeutic intent during testing of anticancer drugs.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should require the Commissioner, FDA, to give sponsors and clinical investigators more precise guidance as to what types of reactions they should report as ADR, and when they should report possible ADR in cases in which the reaction's relationship to the drug is uncertain. This should include specific time frames for reporting ADR to FDA.
Closed – Implemented
Final IND regulations, containing these provisions, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should require the Commissioner, FDA, to urge sponsors, if they have not already done so, to establish definite time frames for clinical investigator reporting of ADR, which will allow the sponsors time to meet FDA reporting requirements.
Closed – Implemented
Final regulations, containing this provision, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should instruct sponsors to label, or otherwise highlight, ADR forms or mailing envelopes to ensure that ADR will be recognized and dealt with immediately upon their arrival at FDA.
Closed – Implemented
Final regulations, containing this provision, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should require the Director, NCI, to review the need for and usefulness of its drug study database. If needed, NCI should require clinical investigators to submit data in a more timely and complete manner. If not needed, NCI should terminate the effort.
Closed – Implemented
NCI determined that there is a need for its drug study base and developed and implemented a computerized system for collecting data directly from clinical investigators in a uniform and timely manner. NCI also adopted a standardized reporting system for the few studies conducted without computer capabilities.
Department of Health and Human Services The Secretary of Health and Human Services should require the Director, NCI, to: (1) ensure that NCI site visit monitoring includes all NCI investigators; (2) devise a procedure to verify investigators' drug disbursements to their satellite locations or require that drug shipments be made directly to these locations by NCI; and (3) if possible within allocated resources, increase the frequency of site visits to monitor investigators' performances.
Closed – Implemented
The Department of Health and Human Services (HHS) completed action to ensure that NCI site visit monitoring includes all NCI investigators and now requires that drug shipments be made to satellite locations directly. However, HHS did not agree that its site visit frequency should be increased.
Department of Health and Human Services The Secretary of Health and Human Services should require the Commissioner, FDA, to: (1) issue final sponsor-monitoring regulations; and (2) establish specific requirements for information to be included in progress reports submitted by sponsors of drug studies.
Closed – Implemented
Final IND regulations, containing sponsor-monitoring responsibilities, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to require that IND reviewers document for the record, within 30 days of the date an IND is submitted to FDA for initial review, that they have satisfied themselves as to the safety of patients participating in tests of new anticancer drugs.
Closed – Implemented
In August 1983, FDA issued a memorandum to all appropriate management and reviewing staff stressing the need for documenting 30-day reviews.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to require that IND reviewers, whenever practical, discuss all IND deficiencies with sponsors before clinical testing begins, or promptly after a deficiency is noted if testing has already begun, and then communicate all such deficiencies in writing to the sponsor in a timely manner. To deal with situations where this procedure is not practicable, guidance should be developed to assist FDA reviewers in determining which deficiencies are sufficiently significant to be communicated promptly to test sponsors.
Closed – Not Implemented
HHS did not agree that all deficiencies should be discussed with drug sponsors immediately because it does not consider all deficiencies to be of critical importance to patient safety.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish a formal follow-up system so that FDA can know whether IND sponsors respond to its recommendations to improve patient safety.
Closed – Not Implemented
HHS did not believe that the need for a formal follow-up system has been demonstrated. It has agreed to study the problem to see if a need exists.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to revise its regulations to require sponsors to approve and submit for FDA review, before clinical testing begins, all clinical protocols.
Closed – Implemented
Final IND regulations, containing these provisions, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a system for identifying major IND amendments and promptly distributing them to reviewers.
Closed – Implemented
Final IND regulations, requiring sponsors to clearly label IND amendments, were issued on March 19, 1987.
Department of Health and Human Services The Secretary of Health and Human Services should require the Director, NCI, to advise FDA in a timely manner of actions taken, or to be taken, on concerns raised by FDA during its review of NCI IND applications.
Closed – Not Implemented
HHS contended that its channels of communication between NCI and FDA were sufficient.

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Cancer researchSubstance abuse treatmentEligibility criteriaPatient care servicesPharmacological researchReporting requirementsResearch program managementTestingToxic substancesProtocols