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PubMed2002

Surgical trials in oncology. the importance of quality control in the TME trial.

Results from randomised trials provide the best scientific evidence of efficacy or inefficacy of the therapy. The evaluation of surgical procedures involves problems in addition to those associated with medical experimentation. Surgery, unlike a pill, is not a standardised, reproducible entity, but a unique product whose details are defined by, for example, the skill of the surgeon. Quality assurance is important for treatment and also for data handling. The different treatments (surgery, pathology, radiotherapy, etc.) should be familiar to all participating physicians prior to the start of the trial. Instructions can be given by means of a well-written protocol, videotapes, workshops and instructors at the dissection table. The data collection and data check should be done by data managers and co-ordinators for the separate disciplines. Errors and missing data should be completed and feedback to the physician is essential. Close contact between an active co-ordinating data centre, including co-ordinators for the separate disciplines, and all participating physicians is essential to conduct a quality controlled multicentre, multidisciplinary trial. Continuous enthusiasm can be maintained by the organisation of regular workshops, distribution of newsletters and trial up-dates at scientific meetings. The efforts from all of the involved co-ordinators, data managers, instructors and physicians have resulted in a very successful trial with rapid accrual, good quality treatments and procedures, good quality data, and a high participation rate among hospitals and patients. Quality control is expensive and labour-intensive, but it is worthwhile.

Colorectal Neoplasms↗
PubMed2006

Clinical trial registries and clinical trial result posting: new paradigm for medical writers.

Clinical trial registries and posting of clinical trial results have recently become standard procedures for drug development. Several groups, including journal editors and professional trade organizations have called for legislation or have mandated terms or both for the public disclosure of current trials and the results of the clinical trials within a short timeframe after the trial has ended.

Clinical Trials as Topic↗
PubMed2003

Clinical trials of prophylactic implantable defibrillator therapy in patients with nonischemic cardiomyopathy: what have we learned and what can we expect from future trials?

Several randomized clinical trials have been designed to evaluate the usefulness of prophylactic implantable cardioverter defibrillator (ICD) therapy in patients with nonischemic cardiomyopathy. In 2 trials, CAT and AMIOVIRT, no survival benefit was reported for patients with dilated cardiomyopathy and prophylactic ICD therapy. The major limitation of both trials is the small sample size of 104 patients in CAT and 103 patients in AMIOVIRT. Another limitation of both trials is the lack of a run-in phase on optimized medical therapy. Since LV function may improve considerably on optimized medical therapy, LV function should be reevaluated 3 to 4 months after initiation of ACE inhibitors, ss-blockers and aldosterone antagonists before prophylactic ICD therapy is considered. Two additional trials, DEFINITE and SCD-HEFT, are still ongoing. Particularly SCD-HEFT will follow a sufficient number of patients with nonischemic cardiomyopathy to give a more definitive answer with regard to the clinical usefulness of prophylactic ICDs in patients with nonischemic cardiomyopathy. Recently, the Marburg Cardiomyopathy study (MACAS) was finished. The results of MACAS strongly suggest that reduced LV ejection fraction is the most important arrhythmia risk predictor in idiopathic dilated cardiomyopathy, whereas signal-averaged ECG, baroreflex sensitivity, heart rate variability and T wave alternans do not appear to be helpful for arrhythmia risk stratification. In addition, MACAS showed that total mortality in patients with idiopathic dilated cardiomyopathy and an ejection fraction <30% is only about 5% per year on optimized medical therapy after exclusion of patients with end stage heart failure and after exclusion of patients with sustained ventricular arrhythmias. Thus, any future study designed to demonstrate a mortality benefit by prophylactic ICD therapy with an 80% power in this patient population needs to enroll more than 1000 patients.

Adrenergic beta-Antagonists↗
PubMed2005

Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial.

BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in clinical hypertension trials. A second objective of this article was to describe the baseline characteristics of the HOMERUS-trial. METHODS: The HOMERUS population consisted of 459 mild-to-moderate hypertensive subjects (54% males) with a mean age of 55 years. These patients were prospectively randomized with the minimization method to either the office pressure (OP) group, where antihypertensive treatment was based on office blood pressure (BP) values, or to the self-pressure (SP) group, where treatment was based on self-measured BP values. Minimization was compared with two other randomization methods, which were performed post-hoc: (i) non-stratified randomization with four permuted blocks, and (ii) stratified randomization with four permuted blocks and 16 strata. In addition, several factors that could influence outcome were investigated for their effect on BP by 24-h ambulatory blood pressure monitoring (ABPM). RESULTS: Minimization and stratified randomization did not lead to significant differences in 24-h ABPM values between the two treatment groups. Non-stratified randomization resulted in a significant difference in 24-h diastolic ABPM between the groups. Factors that caused significant differences in 24-h ABPM values were: region, centre of patient recruitment, age, gender, microalbuminuria, left ventricular hypertrophy and obesity. CONCLUSION: Minimization and stratified randomization are appropriate methods for use in clinical trials. Many outcome factors should be taken into account for their potential influence on BP levels. Recommendation. Due to the large number of potential outcome factors that can influence BP levels, minimization should be the preferred method for use in clinical hypertension trials, as it has the potential to randomize more outcome factors than stratified randomization.

Adult↗
PubMedDate not supplied

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Bias↗
PubMed2004

Clinical trial design considerations in assessing long-term functional impacts of tiotropium in COPD: the UPLIFT trial.

An accelerated loss of lung function is one of the defining characteristics of chronic obstructive pulmonary disease (COPD). To date, the only successful intervention shown to conclusively attenuate the loss of lung function over time is smoking cessation. Pharmacological interventions including inhaled corticosteroids and ipratropium bromide have not altered the rate of decline of lung function. Tiotropium is an inhaled anticholinergic that provides 24-hour bronchodilation with once-daily dosing due to prolonged muscarinic M3 receptor blockade. Controlled clinical trials have suggested sustained efficacy for periods of up to one year. We therefore initiated a four-year, controlled clinical trial (UPLIFT, Understanding the Potential Long-Term Impacts on Function with Tiotropium) in patients with COPD to evaluate the long-term effects of tiotropium on the rate of decline in lung function and health status as well as the frequency of exacerbations. The design of such large, long-term clinical trials presents unique methodological challenges including the definition of endpoints, the quality and variability of spirometric measurements and premature patient discontinuations from the trial. The present manuscript outlines the rationale for the UPLIFT study, and reviews the study design and the steps taken to address methodological challenges experienced in other long term studies. Careful design and implementation of the UPLIFT trial is anticipated to yield high quality results that will help in increasing our understanding of the long term natural history of COPD in a global population as well as to elucidate the role that tiotropium can play in affecting the course of this debilitating disease.

Administration, Inhalation↗
PubMed2001

Trial-related discrimination in HIV vaccine clinical trials.

Participants in preventive HIV vaccine trials may experience negative social consequences of trial participation, including problems related to a vaccine-induced positive HIV antibody test, yet few vaccine studies have reported on this issue. From October 1995 through November 1998, 1516 AIDS Vaccine Evaluation Group (AVEG) volunteers were assessed for reports of trial-related discrimination (TRD). Ninety TRD events were reported by 76 (5%) of 1516 volunteers. The most commonly reported incidents (n = 52, 57.8%) were negative reactions of friends, family, and co-workers to the volunteer. Few incidents (approximately 10%) were reported as linked to HIV testing. The majority of events (n = 47, 52%) were described by volunteers as "resolved" at the time of reporting, 36 (40%) as "not resolved," and for 7 (8%) events volunteers did not report resolution status. Reported incidents were analyzed by logistic regression to determine their association with the volunteer's age, sex, race, sexual orientation, and HIV risk category. There was no association between volunteer characteristics and TRD. Logistic regression and analysis of variance (ANOVA) were used to analyze association of trial sites with the number of TRD events reported. After controlling for site variation in data collection and reporting, no significant differences were found between the sites in terms of the number or type of TRD reported. Fears that TRD would be widespread and severe have not been borne out by this analysis. While the results of this study are reassuring, they should be interpreted with caution, as it is unclear whether these results may be extended to phase III trials enrolling large numbers of individuals at higher risk of HIV acquisition.

AIDS Vaccines↗
PubMed2002

Interferon trials in small cell lung cancer at one institution: a comparison of results obtained before and after initiation of systematic treatment trials using IFN-alpha in combination with other modalities.

Chemotherapy became the primary treatment for small cell lung cancer (SCLC) in the early 1970s. The standard drug combinations were first vincristine, adriamycin, and cyclophosphamide (VAC) and then, from the early 1980s, etoposide-platinum combinations. Despite a good initial objective response, however, patients usually suffer a rapid relapse. Treatment development has, therefore, focused on ways to overcome drug resistance, and on the addition of cytokines to the chemotherapeutic arsenal. Interferon (IFN) was one of the first cytokines found to have anticancer effects, and it was introduced into the combined modality regimens used to treat SCLC in the early 1980s in an attempt to overcome the problem of early relapse. The role of IFN was investigated with the aim of establishing how best to combine it with other treatments for SCLC. In this paper, we review the impact of IFN on the outcome for 714 SCLC patients who were treated in randomized IFN trials at one institution over a period of 20 years and IFN trials conducted at other institutions during the same period. The parameters we used at our institution to measure outcome tended to improve during the period when patients were being treated in our three randomized IFN trials, compared with the period when patients received only standard treatment in a nonclinical trial setting. However, the differences were not statistically significant. During this period, IFN was used as maintenance therapy, concomitantly with chemotherapy, and combined with other treatment modalities. Our experience is that IFN-alpha is most effective when administered as low-dose maintenance treatment. Other IFN trials published during the same period were small and heterogeneous. Results were inconsistent and added little new information, although it has been shown that high pretreatment levels of serum vascular endothelial growth factor (VEGF) predict a poor response to treatment and consequently a poor outcome. The recently confirmed antiangiogenic properties of IFN deserve to be investigated in studies of maintenance treatment, in combination with other biologic agents. Patient should be selected according to criteria based on pretreatment assessment of biologic markers, such as VEGF and basic fibroblast growth factor (bFGF). Our studies, all at one institution, pioneered the biologic treatment of solid tumors and developed a solid basis of knowledge for future studies of biologic agents in cancer treatment.

Antineoplastic Agents↗
PubMed2006

Meeting the challenges of implementing process evaluation within randomized controlled trials: the example of ASSIST (A Stop Smoking in Schools Trial).

It is increasingly argued that the effectiveness of health promotion interventions should be measured to inform policy and practice. The randomized controlled trial (RCT) continues to be regarded as the 'gold standard' of health services research but health promotion practitioners have raised concerns about the RCT's appropriateness for evaluating their work. A preferred model is currently the pragmatic trial, measuring effectiveness under 'routine' conditions, incorporating a process evaluation to examine context, implementation and receipt. This model was chosen by A Stop Smoking in Schools Trial (ASSIST) to evaluate an intervention in which influential Year 8 students (12-13 years old) were trained to encourage non-smoking behaviour through informal conversations with their peers. Outcome data show that the intervention was effective in reducing smoking levels in intervention schools compared with control schools. In this paper we describe the extensive process evaluation embedded within the trial and, rather than focusing on resultant data, we consider the potential for such detailed examination of process to affect the intervention's delivery, receipt and outcome evaluation. We describe how some acknowledged challenges were addressed within ASSIST, which have relevance for future similar trials: Hawthorne effects, overlapping roles within the team and distinguishing between the intervention and its evaluation.

Adolescent↗
PubMed2003

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial.

This article describes the development of the protocol for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's disease trial, which was developed in collaboration with the National Institute of Mental Health to assess the effectiveness of atypical antipsychotics for psychosis and/or agitation occurring in outpatients with Alzheimer's disease. The article provides a detailed description of the methodology used in the trial as well as the clinical outcomes and effectiveness measures incorporated into it, discussing the most salient issues encountered in developing the design of the trial, as well as the unique features of the trial.

Aged↗
PubMedDate not supplied

The AIDS Clinical Trials Information Service (ACTIS): a decade of providing clinical trials information.

The AIDS Clinical Trials Information Service (ACTIS) is a central resource for information about federally and privately funded HIV/AIDS clinical trials. Sponsored by four components of the U.S. Department of Health and Human Services, ACTIS has been a key part of U.S. HIV/AIDS information and education services since 1989. ACTIS offers a toll-free telephone service, through which trained information specialists can provide callers with information about AIDS clinical trials in English or Spanish, and a website that provides access to clinical trials databases and a variety of educational resources. Future priorities include the development of new resources to target diverse and underserved populations. In addition, research needs to be conducted on the use of telephone services vs. Web-based information exchange to ensure the broadest possible dissemination of up-to-date information on HIV infection and clinical trials.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Learning by doing: teaching critical appraisal of randomized trials by performing an in-class randomized trial.

OBJECTIVE: Our medical students often encounter difficulty because many have trouble appreciating the relative merits and limitations of clinical research design. In order to remedy these deficits, we developed a novel in-class simulated randomized trial in which students were blinded to their treatment assignment. Specifically, our goals for the session were to demonstrate the importance of randomization of subject populations, to define and use basic terminology such as relative risk reduction along with absolute risk reduction, and to demonstrate the strengths and pitfalls of analysis of subsets of subjects. DESCRIPTION: We proposed the study of a hypothetical new drug, "Flunkimmune," which was claimed to prevent students from failing tests. Students received a random assignment to either the "Flunkimmune" or the placebo group. Students then received an opaque plastic egg appropriate for their randomization. We had prepared the eggs a-priori to each contain a piece of candy, and some to contain a blue dot. The flavor of the candy signified whether a particular student was in the treatment or control group. After all students had received their eggs, we "unblinded" the study by having the students open their eggs and learn to which treatment they had received. We then used an audience response system to construct a demographics table commonly known as Table 1 for the randomized trial-based characteristics of the students' choosing (e.g., "drinks Diet cola," "over six feet tall," "birth weight under seven pounds"). We asked the class to critique their own Table 1 and to comment on the adequacy of the randomization. Students were then informed that the presence of the blue dot signified a "failing" grade on a hypothetical exam to test the efficacy of "Flunkimmune." The eggs had been loaded so that the treatment group had a relative risk reduction of failure rates of 50% compared with the control group and an absolute risk reduction of 20%. This result prompted a debate among students about the relative merits of absolute or relative risk reduction in reporting the results of the study. Students also performed subgroup analyses by determining the failure rates for treatment and control students seated in particular aisles of the lecture hall. This enhanced discussion about the processes of bias and confounding inherent in subgroup analyses. DISCUSSION: This experiential teaching method allowed students to participate directly in a simulated randomized controlled trial, thereby facilitating understanding of this type of study. Students reported that the experience was enjoyable and stimulated active engagement with critical appraisal of randomized trials. Students' subsequent homework assignments, in which they were asked to critically appraise a randomized trial, demonstrated a depth of understanding not previously encountered at this level. We plan to develop and rigorously evaluate additional experiential activities that expose students to the role of the research investigator.

Education, Medical, Undergraduate↗
PubMed1998

Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States.

OBJECTIVE: To determine the willingness of populations at high risk of HIV-1 infection to participate in HIV vaccine efficacy trials, determine factors influencing decision-making, and evaluate knowledge levels of vaccine trial concepts. DESIGN: Cross-sectional study. METHODS: HIV-1-negative homosexual men, male and female injecting drug users and non-injecting women at heterosexual risk were recruited in eight cities in the United States (n=4892). RESULTS: A substantial proportion of the study population (77%) would definitely (27%) or probably (50%) be willing to participate in a randomized vaccine efficacy trial. Increased willingness was associated with high-risk behaviors, lower education level, being uninsured or covered by public insurance, and not having been in a previous vaccine preparedness study. Altruism and a desire for protection from the vaccine were major motivators for participation. Major concerns included positive HIV-1 antibody test due to vaccine, safety of the vaccine, and possible problems with insurance or foreign travel. Baseline knowledge of vaccine trial concepts was low. CONCLUSIONS: It is likely that high-risk volunteers will be willing to enroll in HIV vaccine efficacy trials. A variety of participant and community educational strategies are needed to address participant concerns, and to ensure understanding of key concepts prior to giving consent for participation.

AIDS Vaccines↗
PubMed2006

Morning compared with evening induction of labor: a nested randomized controlled trial. A nested randomized controlled trial.

OBJECTIVE: To test the hypothesis that commencing induction of labor in the morning more closely reflects the physiologic timing of onset of labor and is associated with fewer women who remain undelivered 24 hours after cervical ripening and induction begins. METHODS: This was a nested randomized clinical trial, conducted between April 2001 and December 2004. Pregnant women at more than 36+6 weeks gestation with a cephalic presentation who were scheduled for prostaglandin induction of labor were eligible to participate. Women were randomly assigned to either admission in the morning (0800 hours) or admission in the evening (2,000 hours). The primary outcome measures were vaginal birth not achieved in 24 hours, uterine hyperstimulation with associated fetal heart rate changes, and cesarean delivery. RESULTS: A total of 620 women were entered in the trial, with 280 women in the morning admission group and 340 women in the evening admission group. There were no statistically significant differences between the timing of admission for induction and the primary trial outcomes. However, women admitted in the morning were less likely to require oxytocin infusion (morning admission 126 of 280 [45.0%] compared with evening admission 184 of 340 [54.1%]; relative risk 0.83, 95% confidence interval 0.70-0.97; P=.022). Nulliparous women admitted in the morning were less likely to require operative vaginal birth (morning admission 10 of 62 [16.1%] compared with evening admission 28 of 82 [34.2%]; relative risk 0.47, 95% confidence interval 0.25-0.90; P=.015). CONCLUSION: For women who require induction of labor, consideration should be given to admission in the morning rather than admission in the evening. CLINICAL TRIAL REGISTRATION: Australian Clinical Trials Registry, www.actr.org.au, 12606000156583.

Adult↗
PubMed2005

The effect of a therapeutic trial of high-dose rabeprazole on symptom response of patients with non-cardiac chest pain: a randomized, double-blind, placebo-controlled, crossover trial.

BACKGROUND: Therapeutic trials with high-dose lansoprazole and omeprazole have been shown to be sensitive clinical tools for diagnosing patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. AIM: To determine the clinical value of a therapeutic trial of high-dose rabeprazole over 7 days in detecting patients with gastro-oesophageal reflux disease-related non-cardiac chest pain. METHODS: Double-blind, randomized, placebo-controlled, crossover study. Patients referred by a cardiologist after a comprehensive cardiac work-up were enrolled into the study. Oesophageal mucosal disease was determined by upper endoscopy and 24-h oesophageal pH monitoring assessed acid exposure. Patients were then randomized to either placebo or rabeprazole 20 mg am and 20 mg pm for 7 days. After a washout period of 1 week, patients crossed over to the other arm of the study for an additional 7 days. Patients completed a daily diary assessing severity and frequency of chest pain throughout the baseline, treatment and wash-out periods. The rabeprazole therapeutic trial was considered as a diagnostic tool, if chest pain scores improved > or =50% from baseline. RESULTS: Of the 35 patients enrolled, 16 (46%) were diagnosed as gastro-oesophageal reflux disease-positive and 19 (54%) as gastro-oesophageal reflux disease-negative. Of the gastro-oesophageal reflux disease-positive patients, 12 of 16 (75%) had a significant symptom improvement on rabeprazole when compared with 3 of 16 (19%) on placebo (P = 0.029). Of the gastro-oesophageal reflux disease-negative group, only two of 19 (11%) improved significantly on the medication and four of 19 (21%) on placebo (P = 0.6599). The calculated sensitivity and specificity of the rabeprazole therapeutic trial was 75% and 90%, respectively. CONCLUSIONS: A rabeprazole therapeutic trial is highly sensitive and specific for diagnosing gastro-oesophageal reflux disease-related non-cardiac chest pain patients.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1995

Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials.

OBJECTIVE: To determine how many patients were deprived of treatment by being given placebo as comparator in trials of ondansetron for postoperative nausea and vomiting. DESIGN: Review of published trials of ondansetron during 1991 to July 1994. SETTING: Medline search in a university department of anaesthesia. SUBJECTS: 8806 patients who had been included in 18 indexed placebo controlled trials of ondansetron as prophylaxis against or treatment of postoperative nausea and vomiting. RESULTS: Five studies (1236 patients) had been published by July 1992. All were placebo controlled trials. By July 1994, 8806 patients had been included in 18 indexed placebo controlled studies of prophylaxis or treatment. Only 462 patients had been in studies that compared ondansetron with other drugs, and there were no indexed comparative trials of treatment of nausea and vomiting. Roughly 2180 patients had been given placebo as prophylaxis and 440 had been given placebo when already experiencing postoperative nausea or vomiting. CONCLUSIONS: Around 2620 patients in the reviewed studies were denied existing drugs, which, though not completely effective or without side effects, do bring some relief from postoperative nausea and vomiting. Drug regulatory bodies should collaborate with drug companies to ensure better comparison of new with established drugs. This would avoid placebos being given to more than the fewest patients necessary to confirm effect and would allow doctors to be informed more quickly about relative efficacies.

Anesthesia Department, Hospital↗
PubMed1999

Influence of data display formats on physician investigators' decisions to stop clinical trials: prospective trial with repeated measures.

OBJECTIVE: To examine the effect of the method of data display on physician investigators' decisions to stop hypothetical clinical trials for an unplanned statistical analysis. DESIGN: Prospective, mixed model design with variables between subjects and within subjects (repeated measures). SETTING: Comprehensive cancer centre. PARTICIPANTS: 34 physicians, stratified by academic rank, who were conducting clinical trials. INTERVENTIONS: PARTICIPANTS were shown tables, pie charts, bar graphs, and icon displays containing hypothetical data from a clinical trial and were asked to decide whether to continue the trial or stop for an unplanned statistical analysis. MAIN OUTCOME MEASURE: Percentage of accurate decisions with each type of display. RESULTS: Accuracy of decisions was affected by the type of data display and positive or negative framing of the data. More correct decisions were made with icon displays than with tables, pie charts, and bar graphs (82% v 68%, 56%, and 43%, respectively; P=0.03) and when data were negatively framed rather than positively framed in tables (93% v 47%; P=0.004). CONCLUSIONS: Clinical investigators' decisions can be affected by factors unrelated to the actual data. In the design of clinical trials information systems, careful consideration should be given to the method by which data are framed and displayed in order to reduce the impact of these extraneous factors.

Bias↗
PubMed1997

Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD management; (iii) epidemiological and statistical issues in the design and analysis of community randomised trials; (iv) diagnostic methods for STDs in population surveys; (v) treatment regimens for STDs in rural Africa; and (vi) ethical issues in community trials.

Community Health Services↗