A Pilot Project to Develop Checklist-Based Recommendations on the Requirements for Clinical Cancer Research Centers in Countries with Limited Resources.
Clinical studies are the only controlled way of comparing a new treatment to existing standards. Unfortunately, less than 5% of patients in developed countries are enrolled in clinical trials, thus strongly limiting the possibility of answering important clinical questions. Large numbers of cancer patients are treated in countries with limited resources (CLR). Here, cancer centers that are able to provide good standard of care are capable of contributing by enrolling large numbers of eligible patients into clinical trials. We present a pilot project aimed at developing a set of checklists that include all elements of infrastructure, equipment, staff, and training that a center should possess in order to enroll patients into phase II, III, and IV clinical trials. These elements will be stratified in an incremental list to contain essential, desirable, and optional items. Also, requirements for staffing and training of research staff will be developed. The development of a continuous audit program will be proposed to ensure quality control, and each potential trial center will undergo an initial audit to evaluate its suitability. The checklists may also serve as a guide for centers wishing to participate in clinical trials. The ultimate goal of this project is to increase the number of trial centers in CLR for the benefit of patients, science, and society in general.
Eniu
Alexandru
A
Department of Breast Tumors, Cancer Institute 'I. Chiricuta', Cluj-Napoca, Romania.
J Clin Oncol. 2001 Sep 15;19(18 Suppl):118S-124S
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J Clin Oncol. 2003 Mar 1;21(5):830-5
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