Cancer Research Trials Research Articles

Clinical trials in cancer therapy: Efforts to improve patient enrollment by community oncologists

A prerequisite for the completion of a clinical trial is the accrual of adequate numbers of patients. It is estimated that over 90-95% of all cancer patients are now treated in their local communities by practicing oncologists and are not seen by primary investigators at teaching hospitals. One risk of this trend is decreased patient enrollment into clinical trials. The private practitioner often lacks the academic oncologist's incentives to participate in clinical research. The Hoosier Oncology Group (HOG) is composed of community medical and radiation oncologists (85%) and Indiana University faculty members (15%). In an effort to improve patient enrollment onto clinical cancer research trials, HOG has attempted to identify 1) the major obstacles to patient enrollment by community oncologists and 2) potential aids to overcome such obstacles. One hundred fourteen members were surveyed and 75 responded (66%). The major obstacles were, in descending order: time demands on both the oncologist and his staff; explaining clinical trials to patients; completing flow sheets; perceived increased cost to the patient; remembering protocols; adhering to a rigid protocol. Aids identified as potentially most helpful were, in descending order: pocket-sized synopses of protocols; computer generated, individualized prompts; the availability of a clinical trials specialist to explain the clinical trial to patients and assist in obtaining informed consent; the availability of a video tape which could be used to explain clinical trials to patients. These aids are being implemented with the attempt to systemically study their impact on patient accrual.

The size of clinical trials in cancer research--what are the current needs? Medical Research Council Cancer Therapy Committee.

Most randomised clinical trials of cancer treatment include a few hundred patients or less. Recent statistical papers advocate that sometimes thousands of patients should be entered. In this paper I show that for certain types of cancer trials the 'thousands policy' is not required while for others it is desirable but not feasible. In the latter case other strategies should be considered, such as two-stage phase III studies or parallel studies leading to overviews. There is, however, an important subset of trials for which application of the thousands policy is both necessary and feasible. The key to progress lies partly in the achievement of greater recruitment rates in trails of common cancers and partly in greater inter-group collaboration.

Clinical trials in cancer research--philosophical and methodological considerations: discussion paper.

Clinical trials in cancer research--philosophical and methodological considerations: discussion paper.

Clinical trials in hyperthermic cancer research

Clinical trials in hyperthermic cancer research

Reporting standards and research strategies for controlled trials: Agenda for the editor

From a study in Part I of many papers using controlled clinical trials in cancer research, we summarize quantitatively the frequency of reporting important statistical and procedural matters: randomization, statistical method, blindness, power, sample size, survival, and informed consent. We recommend that editors set standards for such reporting to improve readers' ability to evaluate trials. New research is needed to provide strategies for planning and analyzing collections of trials. We suggest in Part II the areas of generalizability, design, including size and allocation of sample and of volume of material collected, methods of reporting and analyzing imperfections in execution, and new archival work to take advantage, through reanalysis of trials and through analyzing collections of trials, of the substantial bodies of data already available.

Clinical trials in cancer research.

This is a review paper which gives a discussion of various aspects of clinical trials in cancer research. Since the conduct of the first randomized controlled clinical trial in cancer patients in the mid-1950's, substantial progress has been made in the utilization of the clinical trial technique for the evaluation of therapeutic efficiacy. The important elements of a protocol are given with some discussion of items to be considered in designing a protocol. The types of clinical trial (phase I, II, III) are defined, and the place of each phase of study in the context of the search for new treatments is delineated. A comprehensive discussion is given of the elements in the comparative clinical trial (phase III), including objectives, consierations in planning (comparability of treatment groups stratification of patients, feasibility and size of study, and prospective versus retrospective studies). Brief descriptions are given of designs for comparative clinical trials and a trial in oat cell lung carcinoma is discussed in some detail. Finally, some comments and references are given concerning the analysis of clinical trials.

Clinical Trials in Cancer Research

Clinical Trials in Cancer Research