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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 19 recordsLinked to original sources
PubMed1991

Cancer clinical trials. Clinical trials programs.

The National Cancer Institute (NCI) is the largest single sponsor of studies using anti-neoplastic agents with over 100 compounds currently in various stages of clinical testing. Most of the clinical trials are conducted by the NCI sponsored cooperative oncology groups and community oncology programs, cancer centers, and the pharmaceutical industry. These organizations conduct studies both independently as well as in a collaborative fashion.

Clinical Protocols↗
PubMed1995

Inter-Company Collaboration Combination Trials. Clinical Trial Subcommittee of the Inter-Company Collaboration for AIDS Drug Development.

The Inter-Company Collaboration for AIDS Drug Development (ICC) represents a collaborative effort among member companies to facilitate the conduct of clinical trials on AIDS drugs. One of the goals of the ICC is to expedite the development of combination antiretroviral therapy through data and compound sharing. Recently, the ICC formed a consensus master protocol to evaluate rapidly the safety and efficacy of triple-drug combinations of antiretroviral therapy for treatment of HIV-infected patients. This concept builds upon historical work with combination chemotherapy that resulted in treatments to successfully control chronic immunosuppressive, infectious or malignant diseases, such as tuberculosis, leprosy, childhood acute lymphoblastic leukemia, and Hodgkin's lymphoma. Because of limitations on potency and the continuing emergence of drug resistance seen with use of currently available antiretroviral agents in monotherapy and two-drug combination regimens, triple-combination regimens should represent a more promising approach to maximize antiviral activity, maintain long-term efficacy, and reduce the incidence of drug resistance. The ICC master protocol is a randomized, controlled, double-blind study with a treatment duration of 52 weeks. Patients eligible to enroll in this study must have documented HIV infection, with CD4 counts between 200 and 500 cells/mm3, and no history of antiretroviral therapy. The first four triple-drug combinations will be evaluated in two trials. These regimens have been selected based on encouraging data from laboratory and clinical studies. Each ICC trial will consist of three arms, with 75 patients per arm. Protocol ICC 001 will include AZT + zalcitabine (ddC) + saquinavir, AZT + ddC + nevirapine, and AZT + ddC as the control arm.(ABSTRACT TRUNCATED AT 250 WORDS)

Antiviral Agents↗
PubMed1995

Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial.

OBJECTIVE: To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology (ACR) and the Outcome Measures in Clinical Trials (OMERACT) conference committee to be used in clinical trials of rheumatoid arthritis (RA). METHODS: Utilizing data from a multicenter randomized double-blind clinical trial of low-dose cyclosporine and placebo in RA, we estimated the relative efficiency (RE) of measures to detect a treatment effect (relative to tender joint count, which was assigned a value of 1). Four pain measures (10-cm visual analog scale [VAS], 5-point categorical scale, Health Assessment Questionnaire [HAQ] pain index, Arthritis Impact Measurement Scales [AIMS] pain score) and 3 quality-of-life measures (Problem Elicitation Technique [PET], HAQ, AIMS) were compared. RESULTS: Physician and patient global measures were the most responsive instruments, although neither was statistically superior to tender joint count. Swollen joint count, grip strength, pain measured on a 10-cm VAS, and functional status as measured by the PET and HAQ were all of intermediate responsiveness. Morning stiffness, 5-point pain scale, and erythrocyte sedimentation rate were the least responsive instruments. CONCLUSION: This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT:

Adolescent↗
PubMed1994

Prevalence and patterns of use of concomitant medications among participants in three multicenter human immunodeficiency virus type I clinical trials. AIDS Clinical Trials Group (ACTG).

Data on the prevalence and patterns of use of concomitant medications among participants in three large phase III clinical trials of zidovudine (ZDV) in human immunodeficiency virus type 1 (HIV-1) infection were analyzed. Overall, 2,801 patients reported 43,331 uses of concomitant medications. Over 85% of clinical trial participants used one or more concomitant medications at some point during the study. Patients with acquired immune deficiency syndrome (AIDS) used an average of 7.1 drugs per month. Patients with AIDS-related complex (ARC) or who were asymptomatic used relatively fewer drugs: 3.1 and 2.7 per month, respectively. Fourteen percent of patients with AIDS used more than 10 concomitant medications per month. The three most commonly utilized classes of drugs were antiinfectives (57%), analgesics or antipyretics (55%), and vitamins (47%). A total of 17% of patients overall and 30% of AIDS patients used acyclovir while on trial. Consumption of prescription drugs was greater, and "over-the-counter" drugs less, among AIDS patients. Reported use of agents not approved by the Food and Drug Administration or approved drugs used for off-label indications was infrequent. Overall use of concomitant medications did not differ across demographic subgroups when corrected for disease stage at the time of enrollment. White, non-Hispanic, homosexual and bisexual men consumed significantly more antivirals and vitamins than other trial participants. Women in all three protocols took more analgesics or antipyretics than did men.(ABSTRACT TRUNCATED AT 250 WORDS)

AIDS-Related Complex↗
PubMed1993

[Gynecologic oncology and clinical trials].

Clinical trials have been developed tremendously in oncology because of its clear endpoints. In Japan, however, a concept of clinical trial has not been so accepted for long time. Recently, Minister of Health and Welfare announced guide lines of clinical evaluation of anticancer drug and statistical analysis. Elements essential to design of clinical trials are following; the first element is a clearly stated hypothesis. The hypothesis must be testable, that is, the investigator must have a clear idea of how these differences will be determined in this study subjects. The trial must have a well documented protocol and have a well defined primary endpoint by which the anticipated effect of the new treatment will be evaluated. Although one or two secondary endpoints may also be identified in the trial, the primary endpoint is the major focus of the trial and determines trial design, size, and early stopping rules. The clinical trial must be appropriately designed so that the hypothesis can be adequately tested and evaluated. The study may compare the new therapy to a standard treatment or assess the basic characteristics of the treatment. The clinical trial must be designed so that adequate sensitivity (significance level) and power to provide a high degree of confidence that results are not spurious. The next critical aspect to the performance of a successful clinical trial is the ability to accrue adequate numbers of patients within a reasonable period of time for the study to be completed. The next essential element to the design of a clinical trial is the prospective selection of statistical tool appropriate to the data to be collected.(ABSTRACT TRUNCATED AT 250 WORDS)

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

A decade of progress in statistical methodology for clinical trials.

Clinical trials played a dominant and expanding role in the evaluation of new treatments during the decade of the 1980s. There were major improvements in the quality of clinical trials in many medical fields. There were also important developments in the methodology of designing, monitoring, conducting, analysing, reporting and interpreting clinical trials. This paper attempts to review some of these developments. A comprehensive review is beyond the abilities of any one individual. Consequently, this paper attempts to offer a broad stroke description of this area and to highlight specific topics of importance based on my particular experience. An extensive, but non-comprehensive bibliography is included to provide entry points to the literature of methodologic developments for clinical trials in the 1980s.

Clinical Trials as Topic↗
PubMed1993

[The Italian contribution to the application of high-technology methods to clinical trials].

Clinical trials are important research tools currently used in assessing new drugs and therapeutic strategies, which are unable to produce large effects evaluable in small series of patients. We describe methodological principles of clinical trials and significant advantages in their implementation produced by using a computer network for long-distance modem transmission of echocardiographic images and clinical data. This network has been recently developed in Italy and is operative at the University of Bari and the Associazione per la Ricerca in Cardiologia. Several clinical participating centers of the CEDIM Study and PHASE Study are connected in real time to a data center via modem by a special telephone network (RFD) of the Italian State Telephone Company (SIP). We describe the configuration, main features and applicative potential of such a powerful research tool in modem clinical trial methodology.

Cardiology↗
PubMed1987

Should the elderly hypertensive be treated? Evidence from clinical trials.

Clinical trials for over 15 years have addressed the therapeutic utility of treating elderly hypertensives. Many early trials showed no treatment effects. Because of the recent publication of new information, a review of available evidence concerning this issue was undertaken. Eight randomized clinical trials were assessed regarding trial design. The studies varied according to generalizability, diagnostic criteria, choice of therapy, outcome measures assessed, evaluation of compliance, methods of analysis, duration of follow-up, determination of side effects, and ability to exclude a type 2 error. While many of the earlier studies found no treatment effects, they lacked methodologic rigor; more recent studies demonstrated positive treatment effects. Pooling of results from similar trials supports a notable treatment effect in the prevention of stroke. There is also evidence that the elderly are not more susceptible to side effects of antihypertensive drugs, as is generally believed. The best evidence suggests the hypertensive elderly should be treated.

Aged↗
PubMed1992

Modulation of fluorouracil with recombinant alfa interferon: M. D. Anderson Clinical trial.

Clinical trials have been initiated examining the combination of fluorouracil (5-FU) and recombinant interferon alfa-2a (rIFN-2a) in the treatment of advanced colorectal carcinomas. An early trial reported a response rate of 76%, encouraging further investigation. Clinical trials have used 5-FU administered as a continuous intravenous infusion, 750 mg/m2 per day for 5 consecutive days, followed by weekly bolus administration of 5-FU 750 mg/m2. Recombinant interferon alfa-2a, 9 million units, was administered subcutaneously three times weekly. Of 45 evaluable patients treated at The University of Texas M. D. Anderson Cancer Center, a response rate of 35% (95% confidence interval, 22%, 50%) was observed. Twenty-five percent of patients developed grade 4 toxicity and 82% developed grade 3 toxicity. The median survival was 16 months. Investigation of this combination will require randomized trials to further assess activity in relation to alternative treatments.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Guidelines for reporting results of quality of life assessments in clinical trials.

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

Clinical Trials as Topic↗
PubMedDate not supplied

[Ethics and clinical trials].

Clinical research is indispensable for determining the safety and efficacy of drugs in human. It provides the scientific basis for rational drug usage. Methodology of clinical trials can raise some ethical issues. As an example the use of a placebo is described in this paper. Generally the ethical issues may be solved by the adequate information of every individual assigned to clinical investigation in agreement with the Declaration of Helsinki and the Huriet law. This information must be approved by an ethical committee. Finally an information about the general provisions of clinical trials must be destined to the general public.

Clinical Trials as Topic↗
PubMedDate not supplied

Clinical trials.

Clinical trials are a relatively underused form of investigation in family medicine. This paper presents an overview of those considering conducting or assessing a clinical trial. A bibliography for further reading is also provided. Topics covered include aspects of: the development of a protocol; design such as randomization and binding; the special role of non-drug studies in family medicine; measurement--especially combating bias; analysis--particularly the management of drop-outs; and, the problem of generalizability.

Clinical Protocols↗
PubMed1984

Who should code cause of death in a clinical trial?

Clinical trials of intervention in chronic disease often use cause-specific mortality as a principal outcome variable. Surprisingly, there has been little standardization of the approach to determining cause of death. Some studies use standard nosological coding based on the International Statistical Classification of Diseases while others rely on panels of physicians. Some studies utilize autopsy findings; others do not. There is a clear need for standardization, and a unified approach is suggested. In this approach, panels of physicians prepare death certificates and are trained and standardized to generate reproducible information. A system for adjudication of differences is a part of the trial's design. Death certificates are then transmitted to panels of nosologists who assign cause of death. Again, the nosologists are standardized, and an adjudication system for resolving differences is developed. This two-stage system takes advantage of strengths of the two types of cause of death coding now in use in clinical trials and should produce results permitting cross-trial and cross-time comparisons.

Adult↗
PubMed1993

Clinical research units for the treatment of patients with HIV disease: operational issues and components needed to conduct clinical trials.

Clinical trials are of paramount importance for the development and evaluation of new therapies for patients with human immunodeficiency virus (HIV) disease. The objective of an HIV clinical research unit is to conduct high quality clinical research with patients who have HIV disease. The conduct of these research studies requires accurate and complete data collection. Coordination of the patients' primary care must be complemented by a working knowledge of the relevant ethical issues. In addition, technical, managerial, and clinical expertise is needed for conducting the trials and collecting data. To accurately plan the research, personnel and resource allocation should be periodically assessed. Clinicians, particularly those who have not previously conducted clinical trials or who are considering the incorporation of a research program into a primary care setting, must be familiar with these issues in order to create and supervise this type of clinical research unit. A smoothly running clinic observing a defined cohort of patients is attractive to government agencies and pharmaceutical sponsors for funding of clinical trials and research projects.

Clinical Protocols↗