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Results for “Randomized trial”

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PubMed1984

A comparison of surgery and chemonucleolysis in the treatment of sciatica. A prospective randomized trial.

Fifty-two patients with unilateral sciatica caused by intervertebral disc herniation were selected on strict clinical and radiological criteria. All patients had failed to respond to conservative measures. Patients in this trial group randomly were allocated surgery or Chymopapain. During the same period, a further 71 patients, who were put forward for the trial, and did not fulfill the trial criteria, were offered Chymopapain as an alternative to surgery. Both groups were assessed at one month, three months, and one year--progress being recorded by clinical examination and visual analogs. The failure rate in the two Chymopapain groups were comparable, with 52% and 47%, but were significantly higher than the surgical group (11%). Surgery in the failed Chymopapain group frequently was delayed and unrewarding. Failures can be predicted at one month posttreatment, and early surgery may be indicated to prevent chronic scarring.

Adolescent↗

PubMed1997

Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial.

PURPOSE: This prospective randomized multicenter trial was designed to evaluate the efficacy of carboplatin plus etoposide and bleomycin (CEB) versus cisplatin plus etoposide and bleomycin (BEP) in first-line chemotherapy of patients with good-risk nonseminomatous germ cell tumors. PATIENTS AND METHODS: Between September 1989 and May 1993, a total of 598 patients with good-risk nonseminomatous germ cell tumors were randomized to receive four cycles of either BEP or CEB. In each cycle, the etoposide dose was 120 mg/m2 on days 1, 2, and 3, and the bleomycin dose was 30 U on day 2. BEP patients received cisplatin at 20 mg/m2/d on days 1 to 5 or 50 mg/m2 on days 1 and 2. For CEB patients, the carboplatin dose was calculated from the glomerular filtration rate to achieve a serum concentration x time of 5 mg/mL x minutes. Chemotherapy was recycled at 21-day intervals to a total of four cycles. RESULTS: Of patients assessable for response, 253 of 268 (94.4%) of those allocated to receive BEP achieved a complete response, compared with 227 of 260 (87.3%) allocated to receive CEB (P = .009). There were 30 treatment failures in the 300 patients allocated to BEP and 79 in the 298 allocated to CEB (log-rank chi 2 = 26.9; P < .001), which led to failure-free rates at 1 year of 91% (95% confidence interval [CI], 88% to 94%) and 77% (95% CI, 72% to 82%), respectively. There were 10 deaths in patients allocated to BEP and 27 in patients allocated to CEB (log-rank chi 2 = 8.77; P = .003), which led to 3-year survival rates of 97% (95% CI, 95% to 99%) and 90% (95% CI, 86% to 94%), respectively. CONCLUSION: With these drug doses and schedules, combination chemotherapy based on carboplatin was inferior to that based on cisplatin. This BEP regimen that contains moderate doses of etoposide and bleomycin is effective in the treatment of patients with good-prognosis metastatic nonseminoma.

Adult↗

PubMed2003

Prospective evaluation of clinical outcomes after acute ST-elevation myocardial infarction in patients who are ineligible for reperfusion therapy: preliminary results from the TETAMI registry and randomized trial.

BACKGROUND: Treatment with lytics or primary percutaneous coronary interventions (PCI) reduces the mortality rate of patients with ST-elevation myocardial infarction (STEMI) presenting within 12 hours. Patients presenting >12 hours are generally considered to be ineligible for reperfusion therapy, and there are currently no specific treatment recommendations for this subgroup.Methods- All patients with STEMI <24 hours were included in the Treatment with Enoxaparin and Tirofiban in Acute Myocardial Infarction (TETAMI) randomized trial or registry. Those patients who were ineligible for acute reperfusion, had no cardiogenic shock, and were not planned for revascularization within 48 hours were randomized to 1 of 4 antithrombotic regimens involving enoxaparin or unfractionated heparin (UFH), in combination with tirofiban or placebo for 2 to 8 days. A concurrent registry tracked STEMI patients coming in within <12 hours, and who underwent reperfusion. This registry also tracked the remaining STEMI patients who neither received reperfusion nor were enrolled in the TETAMI randomized trial. The demographics and clinical outcomes of all three groups (received reperfusion therapy, too late for reperfusion and enrolled in the randomized trial, neither received reperfusion therapy nor were enrolled in the randomized trial) were prospectively tracked. RESULTS AND CONCLUSIONS: There were 2,737 patients who presented with STEMI or a new left branch bundle block (LBBB), of which 1,654 (60%) presented < or =12 hours. There were 1,196 (72%) of 1,654 patients who received reperfusion therapy. There were 458 (28%) of the 1,654 patients deemed "ineligible" for reperfusion, mostly because of a contraindication to lytics or for being "too old." In contrast, 1,083 (40%) of 2,737 patients presented >12 hours. Apart from 34 of these patients who had a stuttering infarction and were referred for reperfusion, the remaining patients did not receive reperfusion therapy. Registry patients who received reperfusion therapy, compared with TETAMI randomized patients (all of whom received antithrombotic therapy) and registry patients who did not receive reperfusion, were younger (61 years versus 63 years and 67 years), were more likely to be male (78% versus 73% and 63%), and had persistent ST-segment elevation as opposed to LBBB or Q waves. Registry patients who received reperfusion therapy had better clinical outcomes, even after adjusting for admission Killip class, compared with TETAMI randomized patients and registry patients who did not receive reperfusion therapy. TETAMI randomized patients had better outcomes than registry patients who did not receive reperfusion therapy. The major obstacle to expanding the delivery of reperfusion therapy to patients with STEMI is the large fraction of patients who present too late for reperfusion therapy. Examination of prospectively gathered data on STEMI patients who are ineligible for reperfusion may help optimize their treatment.

Age Factors↗

PubMed2002

A 20% dose reduction of the original CISCA/VB regimen allows better tolerance and similar survival rate in disseminated testicular non-seminomatous germ-cell tumors: final results of a phase III randomized trial.

BACKGROUND: This prospective randomized clinical trial was designed to compare the efficacy of a low-dose regimen of cisplatin, doxorubicin and cyclophosphamide alternated with vinblastine and bleomycin (CISCA/VB) with the original CISCA/VB regimen in patients with disseminated nonseminomatous germ-cell tumors (NSGCT) and a predicted favorable outcome. PATIENTS AND METHODS: One hundred and twenty-five patients with disseminated NSGCT and a predicted favorable outcome according to the M.D. Anderson Cancer Center classification [testicular primary and human chorionic gonadotropin (hCG) serum level <50000 mIU/ml] were randomized to receive the original CISCA/VB regimen (100% dose) or a low-dose CISCA/VB regimen (80% dose). RESULTS: Among the 124 eligible patients, there was no significant difference in the number of patients in the two treatment arms who achieved a complete response to therapy: 53 of 65 patients (82%) on the original CISCA/VB regimen and 53 of 59 patients (90%) on the low-dose CISCA/VB regimen (P = 0.29). Overall, the original CISCA/VB regimen resulted in a significantly higher relative dose intensity (P <0.0001). After a median follow-up of 6.8 years (range 0.37 to 12.94 years), there was no significant difference in disease-free survival (P = 0.87) or in overall survival (P = 0.88) between the two treatment arms. The 5-year overall survival rate was 93.7% [95% confidence interval (CI) 88% to 100%] and 94.1% (95% CI 84% to 100%) in the original CISCA/VB arm and the low-dose CISCA/VB arm, respectively. The 5-year overall survival rate for the entire study population was 98% (95% CI 94% to 100%) and 88% (95% CI 76% to 100%) in the good- and intermediate-prognosis groups, respectively, as defined by the International Germ Cell Consensus Classification Group (IGCCCG). The low-dose CISCA/VB regimen resulted in significantly less neutropenic fever (P <0.001), grade 4 thrombocytopenia (P <0.03) and severe mucositis (P <0.01) than the original CISCA/VB regimen. CONCLUSIONS: CISCA/VB is highly efficient in patients with good or intermediate prognosis NSGCT according to the IGCCCG criteria. Although equivalent antitumor efficacy cannot be claimed, the low-dose CISCA/VB regimen appears to be a better mode of delivery than the original CISCA/VB regimen with respect to toxicity, since survival is comparable.

Adolescent↗

PubMed1996

Randomized trials of dietary antioxidants in cardiovascular disease prevention and treatment.

The hypothesis that antioxidant vitamins might reduce cardiovascular disease risk is based on a large body of basic and human epidemiologic research. Basic research provides a plausible mechanism by which antioxidants might reduce the risk of atherosclerosis. A large number of descriptive, case-control and cohort studies provide data suggesting that consumption of antioxidant vitamins is associated with reduced risks of cardiovascular disease. These data raise the question of a role of antioxidants, such as vitamins C and E, and beta-carotene, in the primary prevention of cardiovascular disease, but do not provide a definitive answer. Randomized trial data will be essential in establishing whether or not there is a causal effect of antioxidants in reducing the risk of cardiovascular disease. For many hypotheses randomized trials are neither necessary nor desirable; however, when searching for small to moderate effects, large-scale randomized trials of adequate dose and duration, in which investigators allocate subjects at random to either active treatment or placebo will provide valuable information about whether there is a causal relationship, and provide reliable estimates of effect size. Results from several large-scale randomized trials of antioxidants are summarized in this paper. At present, there is not sufficient data available to define clearly the role of antioxidants in primary or secondary prevention of cardiovascular disease. Additional trial data should be forthcoming in the near future which will aid in individual clinical decision-making and in the establishment of guidelines for the general public.

Antioxidants↗

PubMed2000

Long-term clinical outcome in the Bypass Angioplasty Revascularization Investigation Registry: comparison with the randomized trial. BARI Investigators.

BACKGROUND: The Bypass Angioplasty Revascularization Investigation (BARI) included 4039 patients with multivessel coronary artery disease; 1829 consented to randomization, and 2010 did not but were followed up in a registry. Thus, we can evaluate the outcome of physician-guided versus random assignment of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the baseline features and outcomes for PTCA and CABG in the overall registry and its predesignated subgroups. We assessed the impact of treatment by choice versus random assignment by comparing the results in the registry with those of the randomized trial. Statistical adjustments for differences in baseline characteristics were made. Within the registry, nearly twice as many patients were selected for PTCA (1189) as CABG (625); mortality at 7 years was similar for PTCA (13.9%) and CABG (14.2%) (P=0.66) before and after adjustment for baseline differences between patients selected for PTCA versus CABG (adjusted RR, 1.02; P=0.86). In contrast to the randomized trial, the 7-year mortality rate of treated diabetics in the registry was equally high (26%) with PTCA or CABG. Seven-year mortality was higher for patients undergoing PTCA in the randomized trial than in the registry (19.1% versus 13.9%, P<0.01) but not for those undergoing CABG (15.6% versus 14.2%, P=0.57). The adjusted relative mortality risk for PTCA in the randomized versus registry population was 1.17 (P=0.16). CONCLUSIONS: BARI physicians were able to select PTCA rather than CABG for 65% of registry patients who underwent revascularization without compromising long-term survival either in the overall population or in treated diabetics.

Angina Pectoris↗

PubMed1983

Sensitivity and specificity of clinical trials. Randomized v historical controls.

The relative accuracy of randomized control trials (RCTs) and historical control trials (HCTs) in determining effective therapies has not been compared since there is no external verification of efficacy. We reviewed six therapies studied by both methods. Most HCTs concluded therapy was better than control, but few RCTs agreed. We calculated sensitivity and specificity for each type of trial by combining published results with all possible combinations of effectiveness. The sensitivity of HCTs was 0.80 to 1.00 (mean, 0.90) and specificity was 0.0 to 0.27 (mean, 0.11). The sensitivity of RCTs was 0.0 to 0.27 (mean, 0.12) and specificity was 0.67 to 1.00 (mean, 0.88). Defects of RCTs are more easily corrected than those of HCTs. Readers should consider trial design and the probability of errors when deciding how much credence to give to a clinical trial.

Clinical Trials as Topic↗

PubMed1999

Use of observational databases to evaluate the effectiveness of antiretroviral therapy for HIV infection: comparison of cohort studies with randomized trials. EuroSIDA, the French Hospital Database on HIV and the Swiss HIV Cohort Study Groups.

OBJECTIVES: It is important to assess the extent of bias when comparing the clinical efficacy of antiretroviral regimens in observational databases because, with the current lack of planned large trials, such analyses may represent the only means of assessing the risk of serious clinical events associated with new regimens. We aimed to compare the results from observational databases with those from randomized trials. METHODS: Three treatment comparisons from randomized trials [Delta, AIDS Clinical Trials Group (ACTG) 175, Community Programs for Clinical Research on AIDS (CPCRA) 007 and ACTC 320] were mimicked in cohorts: (i) zidovudine monotherapy versus combination regimens of two nucleoside analogues; (ii) zidovudine combined with either didanosine or zalcitabine; and (iii) a dual combination versus a triple regimen including a protease inhibitor. Data for over 10 000 patients from the French Hospital Database on HIV, the EuroSIDA study and the Swiss HIV cohort study were analysed for each of the comparisons. Progression to AIDS disease or death was analysed in Cox models, adjusting for baseline differences, and results compared with randomized trials. RESULTS: For comparison (i) the adjusted relative risk estimates from cohorts were between 0.61 and 0.84, favouring combinations over monotherapy, compared with 0.57 to 0.63 for trials. For comparison (ii) relative risk estimates from cohorts ranged from 0.81 to 1.01 compared with 0.77 to 0.92 for trials. For comparison (iii), two of the cohorts showed similar results to the ACTG 320 trial but one indicated a higher risk of progression on triple therapy [relative risk 1.20, 95% confidence interval (CI) 1.01-1.441, in direct contrast to the trial result (relative risk 0.50, 95% CI 0.33-0.76). CONCLUSION: Serious biases can be present when comparing outcomes from the use of antiretroviral regimens in observational studies. However, such bias is not inevitable and careful interpretation of the results from several observational studies considered together is likely to be informative, guiding the design of new trials.

Anti-HIV Agents↗

PubMed1986

Advanced stage III ovarian carcinoma. Prospective randomized trials comparing radiotherapy and chemotherapy.

A prospective randomized trial was carried out in 128 patients with advanced stage III ovarian tumors of serous and anaplastic type, to compare the effects of radiotherapy, single-drug chemotherapy and combination chemotherapy on operability and survival. The effect on operability was about the same for radiotherapy as for combination chemotherapy, whereas single-drug chemotherapy was less effective. The effect on survival was significantly greater with the combination chemotherapy than with radiotherapy and single-drug chemotherapy, which were roughly similar. This better survival with combination chemotherapy was observed in both poorly and moderately differentiated tumors.

Adolescent↗

PubMed1990

Injection therapy of bleeding peptic ulcer. A prospective, randomized trial using epinephrine and thrombin.

A prospective randomized trial involving 64 patients with bleeding peptic ulcers was performed to assess the efficacy of two modalities of injection therapy. The inclusion criterion was the presence of active bleeding or a visible vessel at emergency endoscopy. Thirty-two patients were treated with epinephrine (Group A) and 32 with epinephrine plus thrombin (Group B). Permanent hemostasis was achieved in 81.3% Group A, and 84.4% Group B patients, and therapy failures occurred in 18.6% and 15.6%, respectively. Mortality was nil in both groups. There were no differences in the requirement for emergency surgery, or in the number of transfusions in the two groups. A second elective endoscopy was performed in 49 patients between the 3rd and the 5th day after admission, proceeding to a second injection therapy if a visible vessel was still seen. There were no failures among re-injected patients. With one exception, none of the failures occurred in patients in whom a second endoscopy was done. Our results suggest that injection therapy, which is a simple technique, should be considered as the initial treatment of choice in bleeding peptic ulcer. The addition of thrombin to epinephrine does not improve the results of the method. An early second endoscopy and local therapy if a visible vessel is still present, may further improve the results.

Aged↗

PubMed1997

Inguinal hernia repair: totally preperitoneal laparoscopic approach versus Stoppa operation: randomized trial of 100 cases.

In a prospective randomized trial comparing the totally preperitoneal (TPP) laparoscopic approach and the Stoppa procedure (open), 100 patients with inguinal hernias (Nyhus IIIA, IIIB, IV) were followed over a 3-year period. Both groups were epidemiologically comparable. In the laparoscopic group, operating time was significantly longer (p = 0.01), but hospital stay (3.2 vs. 7.3 days) and delay in return to work (17 vs. 35 days) were significantly reduced (p = 0.01). Postoperative comfort (less pain) was better (p = 0.001) after laparoscopy. In this group, morbidity was also reduced (4 vs. 20%; p = 0.02). The mean follow-up was 605 days, and 93% of the patients were reviewed at 3 years. There were three (6%) recurrences after TPP, especially at the beginning of the surgeon's learning curve, versus one for the Stoppa procedure (NS). For bilateral hernias, the authors suggest the use of a large prosthesis rather than two small ones to minimize the likelihood of recurrence. In the conditions described, the laparoscopic (TPP) approach to inguinal hernia treatment appears to have the same long-term recurrence rate as the open (Stoppa) procedure but a real advantage in the early postoperative period.

Adult↗

PubMed2004

Statistical considerations for use of composite health-related quality-of-life scores in randomized trials.

BACKGROUND: Quality of life instruments are frequently used as outcomes in randomized trials. Instruments that consist of several subscales present researchers with a choice of whether to combine some or all scales into a single composite score. There may be several clinically and scientifically reasonable alternative combinations of subscales for the primary outcome measure. MAJOR FINDINGS: The statistical efficiency of different combinations of subscales depends on the relative effect size of the intervention on each subscale and the correlation between the subscales. Simple equations can be derived for determining the relative statistical efficiency of each clinically reasonable combination of subscales. Hypothetical scenarios show that the number of patients needed in a clinical trial can be twice as great for some combinations of subscales as for others. CONCLUSIONS: There are often compelling clinical or scientific reasons to use a particular subscale or composite in a randomized trial. In the case where a number of different alternatives would be reasonable, statistical efficiency can help guide the choice of endpoint.

Data Interpretation, Statistical↗

PubMed1999

Explaining community-level variance in group randomized trials.

Between-community variance or community-by-time variance is one of the key factors driving the cost of conducting group randomized trials, which are often very expensive. We investigated empirically whether between-community variance could be reduced by controlling individual- and/or community-level covariates and identified these covariates from four large community-based group randomized trials or surveys: the Working Well Trial; Kaiser Adolescent Survey; Kaiser Adults Survey; and the Eating Patterns Study. We found that adjusting for covariates will often substantially reduce the between-community variance component. Therefore investigators could block the communities according to these covariates, or adjust for these covariates to improve the power of community trials. We found that the community-by-time variance components are always near zero in these data sets, especially for the surveys where a cohort was followed over time. The covariate adjustment had less impact on reducing the community-by-time variance for the cohort samples than for the cross-sectional samples. This suggests that blocking may not be necessary for the design of the group randomized trials where the change from baseline is of primary interest. The Working Well Trial data were used to illustrate this point.

Adolescent↗

PubMed1997

The advantages of community-randomized trials for evaluating lifestyle modification.

Observational studies may provide suggestive evidence for the results of behavior change and lifestyle modification, but they do not replace randomized trials for comparing interventions. To obtain a valid comparison of competing intervention strategies, randomized trials of adequate size are the recommended approach. Randomization avoids bias, achieves balance (on average) of both known and unknown predictive factors between intervention and comparison groups, and provides the basis of statistical tests. The value of randomization is as relevant when investigating community interventions as it is for studies that are directed at individuals. Randomization by group is less efficient statistically than randomization by individual, but there are reasons why randomization by group (such as community) may be chosen, including feasibility of delivery of the intervention, political and administrative considerations, avoiding contamination between individuals allocated to competing interventions, and the very nature of the intervention. One example is the Community Intervention Trial for Smoking Cessation (COMMIT), which involved 11 matched pairs of communities and randomized within these pairs to active community-level intervention versus comparison. For analysis of results, community-level permutation tests (and corresponding test-based confidence intervals) can be designed based on the randomization distribution. The advantages of this approach are that it is robust, and the unit of randomization is the unit of analysis, yet it can incorporate individual-level covariates. Such covariates can play a role in imputation for missing values, adjustment for imbalances, and separate analyses in demographic subsets (with appropriate tests for interaction). A community-randomized trial can investigate a multichannel community-based approach to lifestyle modification, thus providing generalizability coupled with a rigorous evaluation of the intervention.

Adult↗

PubMed1999

Efficacy of epidural steroids in low back pain and sciatica. A critical appraisal by a French Task Force of randomized trials. Critical Analysis Group of the French Society for Rheumatology.

OBJECTIVE: Several randomized trials have suggested recently that epidural steroid injections may not be a valid treatment in common low back pain and sciatica. To clarify this issue, we conducted a critical appraisal of relevant randomized trials published up to 1997. Attention was directed to methodological quality, results, and clinical implications. METHOD: A Medline search identified 13 trials published between 1966 and 1997. Trial methodology was evaluated using a 100-point grid based on four groups of items, namely study population, therapeutic intervention, evaluation method, and data presentation and analysis. RESULTS: Methodology quality scores ranged from 12 to 84 and were unrelated to the results of epidural steroid therapy. Five trials demonstrated greater pain relief within the first month in the steroid group as compared to the control group. Eight trials found no measurable benefits. Obstacles to meaningful comparisons across studies included differences in the patient populations, steroid used, volume injected, and number of injections. None of the published studies used the injection modalities that are standard practice in France. CONCLUSION: Whether epidural steroids are effective in common low back pain and sciatica cannot be determined based on our review.

Evaluation Studies as Topic↗

PubMed2003

Meta-analyses of cluster randomization trials. Power considerations.

A commonly cited purpose for conducting a meta-analysis of randomized trials is to increase the statistical power for detecting the effect of an intervention on a specified set of endpoints. At the same time, it also has been noted by several authors that many large-scale cluster randomization trials have not had the power to detect small or even moderate effect sizes. The loss of efficiency associated with cluster randomization relative to individual randomization, and the frequent failure of investigators to take this loss of efficiency into account at the planning stage of a trial, undoubtedly contributes to this problem. In this article, the authors present an approach that may be used to estimate the power of a planned meta-analysis that includes trials that are cluster randomized. Two examples are presented.

Cluster Analysis↗

PubMed2005

Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

CONTEXT: The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate. OBJECTIVE: To combine data from all randomized trials conducted with abciximab in STEMI. DATA SOURCES: Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004. STUDY SELECTION: We examined all completed, published, randomized trials of abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and abciximab. DATA EXTRACTION: Information on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus. DATA SYNTHESIS: Eleven trials were analyzed, involving 27115 patients (12,602 [46.5%] in the abciximab group, 14,513 [53.5%] in the control group). When compared with the control group, abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36). CONCLUSIONS: This meta-analysis shows that, when compared with the control group, adjunctive abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with abciximab in association with fibrinolysis.

Abciximab↗

PubMed1999

Reports of randomized trials in acute stroke, 1955 to 1995. What proportions were commercially sponsored?

BACKGROUND AND PURPOSE: Research in acute stroke has expanded rapidly. Many potentially important interventions lack commercial potential (eg, admission to a stroke unit). We therefore wished to examine the frequency of reports of randomized trials of interventions for acute stroke over the past 40 years, the source of support for such trials, the reporting of the commercial involvement, and whether the proportion of commercially supported trials had changed. METHODS: Eligible trials were identified from the Cochrane Stroke Group's specialized register of controlled clinical trials. We included all randomized trials in patients with acute stroke which published a full text report, in English, between 1955 and 1995. Two reviewers independently extracted data on the involvement of the pharmaceutical industry in all eligible trials. RESULTS: There was a substantial increase in the number of acute stroke trials published per year between 1955 and 1995. The description of pharmaceutical industry involvement in each trial report was poor. Only a minority of supported trials made explicit statements about the role of the sponsoring company. The proportion of trials apparently supported by the pharmaceutical industry has increased substantially. CONCLUSIONS: The increasingly important role of the pharmaceutical industry in evaluating new treatments gives substantial scope for bias and may not be in the interests of public health. Poor reporting of the sponsor's involvement suggests that modifications to the guidelines for the reporting of randomized controlled trials to include more details of the sponsor's involvement in the design, conduct, management, analysis, and reporting of the trial are justified.

Acute Disease↗