A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms (1999) / Chapter Skim
Currently Skimming:
Contents of Report
Contents of Report
Pages 1-20
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
Government programs and the pharmaceutical industry account for the vast majority of clinical trials for cancer treatment in the United States; trials sponsored by others are rare. Quality Standards for Cancer Treatment Trials All the cancer treatment clinical trials for which Medicare beneficiaries would be eligible (as described above)
|
From page 2... ...
Informed consent is a major focus of IRBs, but they also have more general responsibilities for the conduct of trials. Common Elements of Clinical Trial Review Criteria Review and monitoring procedures among clinical trial sponsors vary, but the content of the reviews is remarkably similar.
|
From page 3... ...
; · procedures provide for initial protocol reviews for approval as well as reviews of progress (at least annually) of trials in all the systems; ~ ongoing responsibility for human subjects issues in trials that are under way rests mainly with the IRBs of the institutions at which patients are actually being enrolled and treated in clinical trials; and · reviews are carried out by experts in methodological areas and the medical subject matter of the trial (i.e., reviews may not be carried out satisfactorily using a "checklist" approach applied by non-experts)
|
From page 4... ...
Once a clinical trial is planned, the scientific review includes consideration of the potential risks to participants, but these are also considered by separate groups concerned exclusively with the safety and rights of study participants. The common areas covered by human subjects reviews are evaluations of: · the scientific background of the stu(ly, the subject population, subject recruitment, risks to subjects, benefits to subjects and society, risk/benefit relationship, investigator credentials, monitoring requirements for the trial, and informed consent procedures.
|
From page 5... ...
NCI-sponsored trials are usually organized by research groups at major medical centers, but patients may be entered into them in a wide range of settings, including community hospitals that are networked to the major cancer centers. The Department of Veterans Affairs ~A)
|
From page 6... ...
The Two Prongs of Clinical Trial Protocol Review and Monitoring In all clinical trial funding review mechanisms, the rights and protections of participants are considered separately from the evaluation of scientific and technical aspects (although scientific and technical review also includes consideration of risks to human subjects)
|
From page 7... ...
The key programs are described below, including the criteria used to review and approval clinical trial protocols, and to monitor the progress of ongoing trials. Underpinning decisions to fund clinical trials through all mechanisms is a two-pronged evaluation system.
|
From page 8... ...
Human Subjects · Are the risks to subjects reasonable, both in relation to the anticipated benefits to subjects and to the importance of knowledge that may rea sonably be expected to result from the research? · If any exemptions from human subject rules have been requested, are they justified?
|
From page 9... ...
In addition, as with all other government-funcled studies, the safety of human subjects, including an adequate informed consent procedure, must be in place at all institutions at which studies take place. Protocols are judged on the following factors: .
|
From page 10... ...
Clinical trials funded through a number of mechanisms take place at all Cancer Centers engaged in clinical research. NTH grants for individual trials or trial programs, trials approved through the Cancer Therapy Evaluation Program, and industry-sponsorec3 trials all will have gone through appropriate review before they are conducted (the review mechanisms for those trials are described in the appropriate portions of this report)
|
From page 11... ...
NCI does not, therefore, review individual clinical trial protocols or the conduct of individual stuclies conducted under the auspices of Cancer Centers, but instead, reviews the mechanisms and criteria in place at each Cancer Center for those tasks. Department of Veterans Affairs Clinical trials taking place in whole or in part at VA medical centers may arise through several mechanisms.
|
From page 12... ...
As with NTH-funded trials, the scientific merit and ethical issues related to human subjects are considered by separate groups. in addition to review by the Human Rights Committee of the Cooperative Studies Program Coordinating Center (which also participates in the development of the trial)
|
From page 13... ...
As is the case at NIH, approval does not necessanly lead to funding, but all approved studies do meet the criteria for scientific merit and protection of human subjects. Review by Participating Medical Centers Once a proposal has received funding approval, the protocol and other documents are sent to each center scheduled to participate in the study, where it is reviewed by the Research and Development Committee and the Subcommittee on Human Studies.
|
From page 14... ...
SPONSORS OF CANCER TREATMENT CLINICAL TRIALS Evaluation of the Scientific Background of the Study · is there sufficient information from earlier preclinical or clinical work to justify further exposure of human beings to the intervention? Evaluation of the Subject Population · Exclusion/inclusion criteria: age, gender, health status.
|
From page 15... ...
Additional Monitoring Should the research be reviewed by the {RB more often than annually? Evaluation of Informed Consent Procedures · Who will solicit informed consent from subjects?
|
From page 16... ...
All research undertaken under an IND also must adhere to the applicable fecleral regulations regarding the protection of human subjects. The Commercial IND Application An IND includes information in three general areas: I
|
From page 17... ...
Noncommercial INDs There are many individual instances in which a physician wishes to give an unapproved drug to a patient, even though the patient is not participating in a formal clinical trial under a commercial IND (as described above)
|
From page 18... ...
, · procedures provide for initial protocol reviews for approval as well as reviews of progress (at least annually) of trials in all the systems, o · ongoing responsibility for human subjects issues in trials that are under way rests mainly with the {RBs of the institutions at which patients are actually being enrolled and treated in clinical trials, and · reviews are carried out by experts in methodological areas and the medical subject matter of the trial (i.e., reviews may not be carried out satisfactorily using a "checklist" approach applied by non-experts)
|
From page 19... ...
Reviews and Procedures to Ensure the Safety and Rights of Participants All scientific protocol reviews include consideration of the potential risks to participants, but these are also consiclered by separate groups concerned only with the safety and rights of study participants. The common areas covered by human subjects reviews are: evaluation of the scientific background of the study, · evaluation of the subject population, · evaluation of subject recruitment, · evaluation of risks to subjects, evaluation of benefits to subjects and society, o ~ J evaluation of r~sk/benefit relationship, evaluation of investigator credentials, evaluation of monitoring requirements for the trial, and evaluation of informed consent procedures.
|
From page 20... ...
The Cancer Centers Program of the National Cancer Institute: Interim Policies and Guidelines Relating to the Cancer-Center Support Grant. Typescript, April 1997.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.