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At least 397 records · Page 22Linked to original sources
PubMed1994

Ensuring reliability of outcome measures in multicenter clinical trials of treatments for acute ischemic stroke. The program developed for the Trial of Org 10172 in Acute Stroke Treatment (TOAST).

BACKGROUND AND PURPOSE: Ensuring the reliability and validity of outcome measures used in clinical trials is essential to the success of the trial. The Trial of Org 10172 in Acute Stroke Treatment (TOAST) is a multicenter clinical trial that is recruiting patients with acute ischemic stroke seen at medical centers across the United States. METHODS: This paper describes an approach to train physicians to use three clinical measures: the National Institutes of Health (NIH) Stroke Scale, a supplemental motor examination, and the Glasgow Outcome Scale. The program included education, certification, remediation when needed, monitoring, and reliability assessment. The goal was to ensure that interrater assessments were as equivalent to one another as possible. RESULTS: Of the first 95 clinicians who began the certification process, 75 passed during the first evaluation. Eighteen of the other physicians were able to complete the process after remediation. The intraclass correlations of both the NIH Stroke Scale and supplemental motor examination exceeded 0.95. The kappa values for the Glasgow Outcome Scale were 0.61 and 0.62 for the first and second ratings of the videotape, respectively. CONCLUSIONS: Our experience suggests that a program that includes educational and certification processes can be performed as part of the design of a multicenter clinical trial. The method of providing educational and testing videotapes to each site so that physicians can be trained and certified is an effective, inexpensive, and practical approach for enhancing and certifying the expertise of the large number of physicians involved in a multicenter study.

Brain Ischemia↗
PubMed2006

Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials.

PURPOSE: To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. METHODS: VICC, a National Cancer Institute-designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. RESULTS: At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. CONCLUSION: There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

Clinical Trials as Topic↗
PubMed2005

Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial.

OBJECTIVE: To compare antibody responses to inhaled human insulin vs. sc human insulin and to determine whether insulin antibody binding is associated with adverse clinical consequences. RESEARCH DESIGN AND METHODS: Insulin antibody data from initial phase II/III trials were analyzed comparing the efficacy and safety of inhaled insulin with various agents, including sc insulin. Additionally, data from a 24-month extension of the phase III studies were examined. Data were pooled into the following three groups based on insulin treatment status at baseline: patients with type 1 diabetes, and patients with type 2 diabetes using insulin and not using insulin at baseline. Ig class analysis was also performed on randomly selected sera from type 1 patients at the end of the initial trials. RESULTS: In the initial trials, greater insulin antibody binding was observed in patients receiving inhaled insulin vs. sc insulin. The greatest antibody responses to inhaled insulin were observed in patients with type 1 diabetes [nonparametric comparison of medians at the end of the study, 22.0% binding (unadjusted 95% confidence interval: 19.5, 24.5)], and the lowest responses were observed in non-insulin-using patients with type 2 diabetes in which there was no difference in median values at the end of the study. There were no correlations between antibody binding and glycemic control (measured using glycosylated hemoglobin), insulin dose requirements, hypoglycemic events, or pulmonary function (measured by changes in forced expiratory volume in 1 sec and diffusion capacity of carbon monoxide). Antibody responses were IgG in type. Differences in antibody levels observed in patients with type 1 vs. type 2 diabetes were maintained over the 24-month extension trials. Peak antibody levels across all groups were generally observed after 6-12 months of insulin therapy. Inhaled insulin therapy was not associated with a greater incidence of allergy or other hypersensitivity reactions. CONCLUSION: Inhaled insulin was observed to produce a larger antibody response than sc insulin. Insulin antibody binding has not been associated with adverse clinical consequences in trials to date.

Administration, Inhalation↗
PubMed2026

Community-tailored One Health educational intervention to enhance knowledge and practices for zoonotic disease prevention in rural Thailand: A protocol for a prospective cluster randomised controlled Trial in Chanthaburi, Thailand (Saan Suk trial).

BACKGROUND: Zoonotic infectious disease risk arises at human-animal-environment interfaces where pathogen spillover can occur. Rural communities living in biodiverse settings may experience frequent contact with wildlife and shared environments through livelihoods, food practices, and economic activities. Reducing spillover risk and strengthening pandemic prevention requires both structural and individual-level change. Community-based interventions that promote awareness, risk perception, self-efficacy, pro-environmental behaviour, and safe coexistence with wildlife may support prevention by shifting behavioural determinants of zoonotic disease risk. The Saan Suk intervention was co-developed with rural communities in Thailand using a Human-Centred Design approach and is grounded in the Health Belief Model and One Health principles. The intervention is intended to be feasible, acceptable, and deliverable through Thailand's established Village Health Volunteer (VHV) system. METHODS: This protocol describes a parallel-arm, cluster-randomised controlled superiority trial that will be conducted during July - October 2026, in Chanthaburi Province, Thailand. 24 villages will be equally randomised to the Saan Suk intervention or the current practice (control). In intervention villages, trained VHVs will deliver, once a week over four weeks, a multimodal One Health educational intervention designed to improve knowledge of zoonotic spillover, promote protective behaviours, reduce risky wildlife-related contacts, and support respectful coexistence with wildlife. Trained outcome assessment teams will conduct structured interviews with 42 adult participants per village, yielding a total sample size of 1,008 participants. The sample size was calculated for the primary outcome, accounting for clustering, with 90% power to detect a medium effect size (6 points on the 0-100 knowledge scale) at a significance level of 0.05, accounting for a design effect with an ICC of 0.028. The primary outcome is knowledge of zoonotic spillover, transmission pathways, risk factors, protective and risky behaviours, and safe coexistence with wildlife. Secondary outcomes include attitudes, self-efficacy, preventive and risky behaviours, and reported contacts with major local reservoir hosts. A structured questionnaire was developed, expert-reviewed, and piloted for the outcome assessment. Outcomes will be analysed using mixed-effects regression models with random effects for village and adjustment for relevant pre-specified confounders. Primary analyses will follow the intention-to-treat principle. DISCUSSION: This trial will evaluate whether a co-designed, VHV-delivered One Health educational programme can improve knowledge of zoonotic disease prevention and behavioural determinants in rural communities living in close contact with wildlife and shared ecosystems. If effective and feasible, Saan Suk could inform integration into routine VHV training and community-based zoonotic disease and pandemic prevention strategies. TRIAL REGISTRATION: The Saan Suk trial is registered with the German Clinical Trials Register (DRKS). Registration ID: DRKS00038582; date of registration: 11 May 2026.

Zoonoses↗
PubMedDate not supplied

Adaptation of the clinical trials directive: recommendations on the contents of a dossier for the request for authorisation of the first trials in human subjects.

The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations: In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]). To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)]. To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority. To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent. To follow the recommendations posted on the Afssaps website for the entire IMP dossier. To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees. To limit the 'substantial' amendments to those provided for in the European guidelines. To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies. All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France.

Clinical Trials as Topic↗
PubMed2006

Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).

OBJECTIVES: To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. DESIGN: Randomised controlled trials (RCTs) were carried out for conservative treatment, sclerotherapy and surgery for varicose veins. An economic analysis was carried out alongside the randomised trial. Economic modelling was undertaken based on the primary data collection and a literature review (database searches undertaken in April 2000 and updated in March 2001). SETTING: Primary data collection was from a large district general hospital and a teaching hospital both in England over a 2-year period from January 1999. Cost-effectiveness analysis and economic modelling were carried out using an NHS perspective. PARTICIPANTS: A total of 1009 patients were recruited. INTERVENTIONS: Thirty-four patents were randomised in Group 1 (minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy), 77 in Group 2 (moderate varicose veins with reflux, randomised between surgery and sclerotherapy) and 246 in Group 3 (severe varicose veins with reflux, randomised between conservative treatment and surgery). The remaining 652 patients formed the observational part of the study. MAIN OUTCOME MEASURES: The cost-effectiveness analysis was based on NHS treatment costs for the 2002--3 financial year, and utilities based on the Short Form 6D (SF-6D) preference-based health measure. For the clinical trial, the outcome measures were health-related quality of life (HRQoL) [Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D), visual analogue scale (VAS) and standard gamble], symptomatic relief, anatomical extent (for which a new classification was developed and validated), patient satisfaction and the incidence of complications. RESULTS: Of the RCTs, only the Group 3 trial was large enough to provide clear results. This showed that surgical treatment produced better results than conservative treatment in terms of HRQoL, symptomatic relief, anatomical extent and patient satisfaction. Clinical outcomes of surgery and sclerotherapy showed significant improvement in the extent of varicose veins, symptomatic and HRQoL parameters. Cost-effectiveness analysis based on the Group 3 trial showed that the surgery produced an estimated discounted benefit of 0.054 quality-adjusted life-year (QALY) over a 2-year period, with an additional discounted cost of pound 387.45, giving an incremental cost-effectiveness ratio (ICER) of pound 7175 per QALY. Economic modelling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon, with an ICER of pound 1936 per QALY. Injection sclerotherapy produced an incremental benefit of approximately 0.044 QALY at a cost of pound 155 when compared with conservative treatment, giving an ICER of pound 3500 per QALY. When surgery was compared with sclerotherapy, surgery produced greater benefit with a lower ICER (showing extended dominance). CONCLUSIONS: Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.

Adolescent↗
PubMed1987

[Termination rules in therapeutic trials. Application of sequential methods in 2 clinical trials in hematology].

In haematology, randomized clinical trials often use survival or disease-free interval as response criterion (censored data). For ethical reasons, interim analyses are usually performed, but these interim analyses lead to an increasing Type I error. Sequential methods allow for repeated testing. Three sequential methods are well-adapted to censored data: group sequential analysis, the sequential probability ratio test and the triangular test. The triangular test has the best properties: it allows an early termination of the trial whatever the difference between the treatment groups and without the risk of long duration trials. Sequential analyses can be performed at the same frequency as the usual interim analyses. These three sequential procedures have been applied to the analysis of two cooperative trials in haematology. It appears that the use of sequential methods has to be recommended in the design of randomized clinical trials with a censored response criterion.

Antibiotics, Antineoplastic↗
PubMed1995

The inclusion of women in clinical trials of antihypertensive medications: a review of twenty-four trials in one pharmacology journal.

Historically the inclusion of women in clinical trials of medications has been limited. To ascertain the inclusion of women in clinical trials of antihypertensive medications, an integrative review of 24 articles was undertaken. The articles were chosen from a representative journal of pharmacology from the years 1992 to 1993. Pharmacology journals frequently are the journal in which clinical trials of medications are published. All trials of antihypertensive medications in this journal from the years 1992 and 1993 were included. Analysis is made of inclusion and exclusion criteria, inclusion rates of women (22.4%), and the inclusion of the elderly and minority groups. Based on this review and others it is difficult to recommend generalization of antihypertensive medication guidelines to women on the basis of clinical trials that include few women.

Adolescent↗
PubMed1998

Testing the role of P-glycoprotein expression in clinical trials: applying pharmacological principles and best methods for detection together with good clinical trials methodology.

P-gp (Pgp) is a cell surface ATPase which confers resistance to many of the most active chemotherapy drugs, including taxol, doxorubicin, and vinca alkaloids. Pgp can be detected in human cancers by immunohistochemistry, RNA probes, or by functional assays utilizing transported fluorescent dyes such as rhodamine. The expression of Pgp in untreated human cancers is highly variable, being almost universal in colon, hepatocellular carcinoma, and renal cell cancers, less common in breast, ovarian, and lymphoid malignancies. At least part of the heterogeneity is attributable to different definitions of positivity even with a given method of detection. In chemotherapy naive cancers, resistant cells may not occur very frequently. Whilst the Goldie-Coldman hypothesis predicts treatment failure if 1 cell in 10(6) expresses a resistance mechanism, no method of detection yet described can reliably achieve this. The field has reached a stage in which it may be possible to detect Pgp accurately in advanced cancers which have failed chemotherapy allowing phase II clinical trials to be performed in Pgp-positive tumors. In terms of which Pgp inhibitors are selected for clinical study it is likely that selection of Pgp inhibitors with nM potency to bind to Pgp will be important. Such drugs should undergo extensive phase I trial evaluation to assess pharmacokinetic interactions with a range of cytotoxic drugs before entering randomized trials. In randomized clinical trials Pgp detection may be less important, as disease-free survival and overall survival would be the key end-points, but the Pgp positivity of relapsed disease would indicate if treatment with inhibitors of Pgp-eliminated Pgp-expressing clones. The accurate detection of Pgp in human cancers is being refined and will be an essential component of future Pgp inhibitor clinical trials. Finally, these trails must be of sufficient size (> 500 patients per arm) to reliably detect clinically meaningful differences.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed1998

Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group.

OBJECTIVES: To investigate the knowledge about randomized clinical trials and the attitude towards clinical research among Danish outpatients and to examine the relationships between outpatient demographic variables and knowledge and attitude. SETTING: Outpatients (n = 415) were recruited from four departments at a university hospital in Copenhagen. METHODS: The participants answered an 18 item multiple choice test evaluating knowledge about randomized clinical trials and a 32 item Likert format questionnaire evaluating attitudes towards clinical research in general and randomized clinical trials. Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance. RESULTS: Mean age for all outpatients was 46 years (range 18-88 years); 251 (60%) were females. A total of 27 outpatients (7%) had previously participated in a randomized clinical trial. Mean knowledge score (number of correct answers out of a maximum of 17) was 7.9 (SD 3.1). Patients in the younger age groups and patients with longer education had significantly higher knowledge scores (p < 0.001). The effect of age group (estimated increase in knowledge score relative to the group 60-89 years) was: 18-29 years 1.2 (SE 0.4); 30-39 years 2.0 (SE 0.4); and 40-59 years 1.6 (SE 0.4). The effect of education (estimated decrease in knowledge score relative to patients with > 12 years of education) was: < 7 years 3.4 (SE 0.4); and 8-11 years 2.0 (SE 0.3). Mean total attitude score was 74.8 (SD 14.8) on a scale from 0-128. Compared to female patients, male patients had an estimated 5.1 points (SE 1.5) higher attitude score (p < 0.001). There was a weak but significant positive association (r = 0.38; p < 0.001) between the knowledge score and the total attitude score. CONCLUSION: Among Danish outpatients knowledge about randomized clinical trials is better in the younger age groups and in individuals with longer education. Overall, better knowledge was associated with a more positive attitude towards clinical research. The question is whether it is possible by simple means to increase knowledge about clinical research and whether an increase in knowledge may positively affect the attitude towards clinical research in individual patients.

Adolescent↗
PubMed2004

Surgical removal vs observation for subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or idiopathic: II. Quality-of-life findings from a randomized clinical trial: SST Group H Trial: SST Report No. 10.

OBJECTIVE: To report findings regarding health-related quality-of-life outcomes by treatment arm, both overall and within subgroups defined by selected baseline characteristics, among patients who participated in the Submacular Surgery Trials (SST) randomized trial of observation vs surgical removal of subfoveal choroidal neovascular lesions that were either idiopathic or associated with ocular histoplasmosis (SST Group H Trial). DESIGN AND METHODS: Eligible patients were 18 years or older and had subfoveal choroidal neovascularization (including a classic component on fluorescein angiography) and visual acuity of 20/50 to 20/800 inclusive in the eye randomly assigned to surgery or observation. Trained interviewers, who were masked to treatment assignment, administered the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-Item Short-Form Health Survey (SF-36), and the Hospital Anxiety and Depression Scale (HADS) by telephone before enrollment and at 6, 12, and 24 months after enrollment; early enrollees also had interviews at 36 and 48 months. Baseline clinical examinations provided data regarding visual acuity, other aspects of vision, and presence of unilateral or bilateral choroidal neovascularization. RESULTS: Of 225 patients interviewed at baseline and enrolled, 201, 190, and 161 patients (respectively, 89%, 85%, and 88% of those eligible to be interviewed) were interviewed 12, 24, and 36 months later. The NEI-VFQ scores in both treatment arms improved from baseline (median score, 75) to the 24-month interview. Patients in the surgery arm had 4-point larger improvements, on average, than patients in the observation arm (95% confidence interval, 1-8 points). The largest differences between treatment arms for mean 24-month improvements from baseline were in the role difficulties subscale (9 points) and dependency subscale (8 points), with larger mean improvements in the surgery arm. Scores on the SF-36 worsened by approximately 1 point on the physical component summary and improved by 2 points or more on the mental component summary in both treatment arms by 24 months in comparison to baseline. The percentage of HADS-defined "definite cases" of both anxiety and depression declined from baseline in each treatment arm. CONCLUSIONS: Vision-targeted quality of life improved more after submacular surgery than with observation, supporting a possible small overall benefit of surgery suggested by the ophthalmic outcomes reported elsewhere. Ophthalmologists and patients similar to those who participated in the SST Group H Trial should be aware of the effects of submacular surgery on specific aspects of vision-targeted quality of life as well as on ophthalmic outcomes when considering this treatment approach.

Adult↗
PubMed1997

Meaningful improvement criteria sets in a rheumatoid arthritis clinical trial. MIRA Trial Group. Minocycline in Rheumatoid Arthritis.

OBJECTIVE: To compare 3 sets of criteria for meaningful improvement in a rheumatoid arthritis (RA) clinical trial, and to evaluate the implications of these criteria sets for RA trial design. METHODS: Data were obtained from the Minocycline in Rheumatoid Arthritis (MIRA) trial (primary outcome measures: 50% improvement in joint tenderness and 50% improvement in joint swelling, based on joint scores). These MIRA data were evaluated against 1) the Paulus criteria (20% improvement in 4 of 6 measures: joint tenderness scores, joint swelling scores, physician's and patient's global assessments, erythrocyte sedimentation rate [ESR], and morning stiffness); and 2) the American College of Rheumatology (ACR) criteria (20% improvement in joint tenderness and joint swelling counts, and in 3 of 5 other measures: physician's and patient's global assessments, ESR, modified Health Assessment Questionnaire, and patient's pain assessment). The ACR criteria were modified using 3 of 4 remaining measures, since baseline pain assessment data were not available. RESULTS: Percentages of minocycline-treated patients versus placebo-treated patients showing meaningful improvement were as follows: by MIRA criteria, for joint tenderness, 56% versus 41% (P = 0.021), and for joint swelling, 54% versus 39% (P = 0.023); by Paulus criteria, 41% versus 28% (P = 0.040); and by ACR criteria, 44% versus 26% (P = 0.004). Both the modified ACR criteria and the Paulus criteria demonstrated a reduced placebo response rate. Compared with the MIRA criteria, the ACR criteria increased, and the Paulus criteria decreased, absolute between-group differences in improvement; however, both criteria sets increased relative percentages of patients showing improvement in the minocycline group versus the placebo group. Study design considerations indicated that application of the ACR criteria would reduce the required sample size. CONCLUSION: Different placebo response rates and treatment group differences were found using the 3 RA improvement criteria sets. These findings support the use of the ACR criteria for defining improvement in RA clinical trials.

Adult↗
PubMedDate not supplied

The applicability of results of streamlined trials to clinical practice: the Myocarditis Treatment Trial.

The application of the results of clinical trials to medical practice depends in part upon the understanding and acceptance of study results by the practising physician. Involving non-academic practitioners as investigators in streamlined trials is an effective means to increase enrollment and minimize cost. Streamlining data collection to accommodate the needs of the practitioner, however, decreases the amount of scientifically and clinically relevant data that are collected. More important, biased enrollment is more likely in this setting. Modifications in organization and design of the Myocarditis Treatment Trial form an example of streamlining an ongoing clinical trial to enhance enrollment.

Cyclosporins↗
PubMedDate not supplied

Triangular test and randomized trials: practical problems in a small cell lung cancer trial.

The triangular test has been used to monitor survival data from a randomized trial in patients with small cell lung cancer. The results of consecutive interim analyses and the problems met by the data monitoring committee and the co-ordinators are described. The methods as well as the consequences of the early stopping on the analysis and the results of this trial are discussed. From this experience, we believe that statistical stopping rules--only one of the factors to be taken into account when deciding to stop a trial--should be used with caution. Independent data monitoring committees may be useful in helping to review the ongoing results and advise the participants in the trial.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1999

Design of the 'Stent or Surgery' trial (SoS): a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease.

The 'Stent or Surgery' trial (SoS) is a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease. This is a multicentre, multinational venture involving over 40 centres in 12 countries throughout Europe and Canada. Eligible and consenting patients will be randomly allocated, in equal proportions, to open revascularization by CABG or by PTCA with the primary implantation of intracoronary stents. The trial design is pragmatic and imposes few protocol restrictions in patient selection, surgical and intervention techniques or adjunctive medication schedules. The rationale and design of the trial are discussed, including important sub-studies, examining quality of life, neuropsychological outcome, cost and cost benefit.

Angioplasty, Balloon, Coronary↗
PubMed1990

Clinical aspects of trial design: what can we expect from the cardiac arrhythmia suppression trial?

The controlled clinical trial, i.e., a prospective study that compares the effect of one or more interventions against a control in human subjects, is the most definitive method to determine the benefit/risk ratio for a treatment. Some of the elements are a clear statement of the primary and secondary hypothesis, carefully defined end points, randomization, double blinding, and concomitant controls for the experimental treatment using either placebo or standard treatment. Randomization tends to produce study groups that are comparable with respect to both known and unknown factors that influence the outcome, and also removes bias in the assignment of subjects to treatments to ensure that statistical hypothesis testing will have valid significance levels. An adequate sample size is critically important for a successful trial. The Cardiac Arrhythmia Suppression Trial (CAST) is a randomized, placebo-controlled, double-blind, international, multicenter clinical trial to determine whether suppression of ventricular arrhythmias after myocardial infarction with long-term antiarrhythmic drug treatment will reduce arrhythmic death. Survivors of myocardial infarction who are less than 80 years of age and have greater than or equal to six ventricular premature depolarizations (VPD) per hour on a 24-hour continuous ECG recording obtained between 6 days and 2 years after myocardial infarction are eligible for CAST.(ABSTRACT TRUNCATED AT 250 WORDS)

Anilides↗
PubMed1988

Leprosy in Malawi. 2. Background, design and prospects of the Karonga Prevention Trial, a leprosy vaccine trial in northern Malawi.

The Karonga Prevention Trial is the largest vaccine trial ever mounted in Africa. It is designed to test two hypotheses: (i) whether the addition of killed Mycobacterium leprae can increase the protection against leprosy (and tuberculosis) imparted by BCG alone; and (ii) whether repeating a BCG vaccination can increase upon the protection provided by an initial dose. The rationale and design of the trial are discussed in relation to the history of vaccination against leprosy and to several contending arguments which determined the ultimate protocol. The potential of the trial to reveal statistically significant differences between the vaccines being compared is discussed, as are the implications of possible results for future research and control of leprosy.

Adolescent↗
PubMed1989

Recruitment in the Hypertension Prevention trial. Hypertension Prevention Trial Research Group.

The Hypertension Prevention Trial (HPT) was a randomized, controlled, multicenter (four clinics, four resource centers) trial designed to test the feasibility of achieving and sustaining dietary changes in the intake of calories, sodium, and potassium and to assess the effect of those changes on blood pressure in a normotensive population. The trial involved 841 men and women (plus a test cohort of 78) who, at the first baseline (BL) examination were in the age range of 25-49 years and had diastolic blood pressure (DBP) greater than or equal to 76 but less than 100 mm Hg (average of two readings), and at the examination prior to randomization (BL 2), had DBP greater than or equal to 78 but less than 90 mm Hg (also averaged). Participants were randomly assigned to a control treatment group (no dietary counseling) or to one of four dietary treatment groups involving counseling designed to reduce calorie intake, reduce sodium intake, reduce sodium and calorie intake, and reduce sodium and increase potassium intake. This chapter describes the process of recruiting participants for the trial. Methods used to identify and contact study participants are presented. Details of the steps involved in the recruitment process and strategies for reducing costs are discussed.

Adult↗