["Workshop on Data Monitoring Committee in NIH"--data monitoring in cancer clinical trial].
Explore the source record for details and available documents.
Clinical Trials as Topic↗
SEARCH · PubMed Health
Results for “Clinical Trials Data Monitoring Committees”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial.
We report on two features of the early termination of the studies of ocular complications of AIDS monoclonal antibody cytomegalovirus retinitis trial: one related to the deliberative process of the treatment effects monitoring body (the policy and data monitoring board [PDMB]) and the other related to the relationships among the PDMB, the investigators, and the joint sponsors (the National Institutes of Health and a pharmaceutical company). The PDMB was challenged with reconciling internally inconsistent safety and mortality data and determining the weight to give mortality data from other concurrently running trials. The coordinating center faced a challenge in negotiating how to communicate results from a jointly sponsored trial. Early resolution of certain organizational and procedural issues, such as rules regarding absentee voting, to which body the monitoring committee should report officially, and the timing and general content of dissemination of different kinds of results, would make jointly sponsored trials more robust to difficulties at the final hour.
AIDS-Related Opportunistic Infections↗
On changing a long-term clinical trial midstream.
Clinical triallists are often reluctant to alter the protocol or the design of an ongoing study in part because of concern that changes may affect the integrity of the study. This paper encourages considering changes in long-term clinical trials when the medical environment changes or when the accruing data from the trial lead to questioning the assumptions underlying the original design. One must make such changes in a way that will not cast doubt on the integrity of the trial. An important aspect of the design is choice of sample size. Methodology for sample size recalculation has matured over the decade. Several techniques are now available for the usual types of endpoints - continuous, discrete and time-to-failure - as well as for longitudinal analysis. Published papers describe the choices of variance at the time of recalculation, approaches to estimation and testing at the end of the study, and the time of recalculation. In a study with a sponsor, a Data Safety Monitoring Board (DSMB) and an Executive Committee, one or more of these three groups is responsible for recommending increases in sample size when the accruing data indicate that the assumed variance underestimated the true variance. Sometimes a statistician independent of all three bodies performs the relevant calculations and sends the recommendation to the sponsor. This paper argues that the DSMB should not generally be the responsible body because knowledge of treatment effect can place it in an uncomfortable position.
Aspirin↗
Rationale and design of the 'F.I.R.E.' study. A multicenter, double-blind, randomized, placebo-controlled study to measure the effect of FX06 (a fibrin-derived peptide Bbeta(15-42)) on ischemia-reperfusion injury in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.
Immediate reopening of acutely occluded coronary arteries via primary percutaneous coronary intervention (PCI) is the treatment of choice to salvage the ischemic myocardium in the setting of ST-segment elevation myocardial infarction (STEMI). However, the sudden re-initiation of blood flow achieved with PCI can lead to a local acute inflammatory response with further endothelial and myocardial damage. This phenomenon, described as 'reperfusion injury', has been recognized for several decades, yet no pharmacologic intervention has so far succeeded in reducing myocardial damage linked to reperfusion. FX06 is a naturally occurring peptide derived from the neo-N-terminus of fibrin (Bbeta(15-42)). It prevents leukocyte migration through the gap junctions of endothelial cells. Experimental studies have shown that FX06 inhibits the binding of the proinflammatory fibrin E1 fragment to VE-cadherin expressed in the adherence junction. It represents a novel approach to reducing local and systemic inflammation, including myocardial reperfusion injury, in the adherens junction. The present multicenter, double-blind, randomized, placebo-controlled study is designed to test the hypothesis that FX06 injection during and immediately after primary PCI can reduce infarct size in patients with STEMI. The primary outcome measure of efficacy in this study is the degree of myocardial salvage calculated as the difference between the perfusion defect before and after PCI, determined by myocardial perfusion scintigraphy during rest. Further, infarct size at the end of the index hospitalization, as well as at 4 months, will be measured by cardiac magnetic resonance imaging. The present position paper describes the rationale, design and the methods utilized in this trial.
Angioplasty, Balloon, Coronary↗
Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial.
CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. INTERVENTIONS: Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
Aged↗
Data and safety monitoring board issues raised in the VA Status Epilepticus Study.
The Department of Veteran Affairs Status Epilepticus Cooperative Study was a randomized, multicenter clinical trial testing four intravenous drug regimens (lorazepam, phenobarbital, phenytoin and diazepam followed by phenytoin) to treat generalized convulsive status epilepticus. During the course of the study, two problems emerged that the study's data and safety monitoring board (DSMB) was required to address: poor recruitment and an unexpected difference in 30-day mortality between treatment groups. By the first annual DSMB meeting, recruitment was only 25.6% of expected. The DSMB recommended placing the study on probation and replacing poorly performing sites. At their second annual meeting, the DSMB recommended approval of proposed changes to the study design contingent on the study leadership removing nonproductive sites. These changes were a 2-year increase in the recruitment period and a change in study design that decreased required sample size. Nonproductive centers were terminated and the approved changes allowed the study to be successfully completed. At the second annual DSMB meeting, an unexpected doubling of mortality rates between drug groups was observed. Although not statistically significant, the finding raised serious concerns for patient safety. The DSMB recommended instituting monthly reporting on mortality and suggested additional analyses for exploring why the differences could be occurring. These analyses indicated that, by chance, older and sicker patients were being randomized to the drugs with the higher mortality rates. By the end of the study, the observed differences in mortality between drug groups had evened out. The DSMB's thoughtful recommendations, support and monitoring ensured that the study was successfully completed without endangering the study patients.
Anticonvulsants↗
The data monitoring experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity (CHARM) program.
BACKGROUND: The CHARM program was designed as 3 separate randomized trials comparing candesartan with placebo in patients with chronic heart failure (CHF) who (1) were intolerant to angiotensin-converting enzyme inhibitor and had left ventricular ejection fraction (LVEF) < or =0.40; (2) were on angiotensin-converting enzyme inhibitor and had LVEF < or =0.40; or (3) had LVEF >0.40. CHARM provides an interesting example of the challenges faced by a Data and Safety Monitoring Committee (DSMC). METHODS: Although the primary efficacy end point for each component trial was cardiovascular (CV) death or hospitalization for CHF, the primary outcome for the overall program was all-cause mortality. The DSMC received monthly safety reports and also met every 6 months (7 times in all) to review interim reports. Statistical stopping guidelines were predefined for all-cause mortality in the overall program. The overarching principle of the DSMC was proof beyond a reasonable doubt that would be likely to influence clinical practice. RESULTS: There were significant treatment differences in all-cause mortality for the overall program at several interim analyses, and the statistical stopping guideline was reached on one occasion. However, even a conventional level of statistical significance (P < .050) was achieved in only 1 of the 3 component trials. The DSMC consistently recommended that the program continue as planned. The final published result for all-cause death over a median of 3.1 years was a 9% reduction in hazard (95% CI 0%-17%, P = .055), whereas for CV death or hospitalization for CHF, there was a 16% reduction in hazard (95% CI 9%-23%, P < .0001). Subsequent exploratory analyses suggest that the hazard reduction in CV death was more marked in the first year after randomization and that, if real, this apparent treatment-time interaction offers a plausible explanation for why the interim mortality data showed statistically more extreme findings than the overall final results. CONCLUSION: The DSMC experience in the CHARM program illustrates the importance of continuing a trial to its scheduled completion unless there is proof beyond a reasonable doubt that would influence clinical practice rather than strict reliance on a statistical stopping guideline.
Angiotensin II Type 1 Receptor Blockers↗
Issues in data monitoring and interim analysis of trials.
OBJECTIVES: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs). DATA SOURCES: Electronic databases. Handsearching of selected books. Personal contacts with experts in the field. REVIEW METHODS: Systematic literature reviews of DMCs and small group processes in decision-making; sample surveys of: reports of RCTs, recently completed and ongoing RCTs and policies of major organisations involved in RCTs; case studies of four DMCs; and interviews with experienced DMC members. All focused on 23 prestated questions. RESULTS: Although still a minority, RCTs increasingly have DMCs. There is wide agreement that nearly all trials need some form of data monitoring. Central to the role of the DMC is monitoring accumulating evidence related to benefit and toxicity; variation in emphasis has been reflected in the plethora of names. DMCs for trials performed for regulatory purposes should be aware of any special requirements and regulatory consequences. Advantages were identified for both larger and smaller DMCs. There is general agreement that a DMC should be independent and multidisciplinary. Consumer and ethicist membership is controversial. The chair is recognised as being particularly influential, and likely to be most effective if he or she is experienced, understands both statistical and clinical issues, and is facilitating in style and impartial. There is no evidence available to judge suggested approaches to training. The review suggested that costs should be covered, but other rewards must be so minimal as to not affect decision-making. It is usual to have a minimum frequency of DMC meetings, with evidence that face-to-face meetings are preferable. It is common to have open sessions and a closed session. A report to a DMC should cover benefits and risks in a balanced way, summarised in an accessible style, avoiding excessive detail, and be as current as possible. Disadvantages of blinded analyses seem to outweigh advantages. Information about comparable studies should be included, although interaction with the DMCs of similar ongoing trials is controversial. A range of formal statistical approaches can be used, although this is only one of a number of considerations. DMCs usually reach decisions by consensus, but other approaches are sometimes used. The general, but not unanimous, view is that DMCs should be advisory rather than executive on the basis that it is the trial organisers who are ultimately responsible for the conduct of the trial. CONCLUSIONS: Some form of data monitoring should be considered for all RCTs, with reasons given where there is no DMC or when any member is not independent. An early DMC meeting is helpful, determining roles and responsibilities; planned operations can be agreed with investigators and sponsors/funders. A template for a DMC charter is suggested. Competing interests should be declared. DMC size (commonly three to eight people) is chosen to optimise performance. Members are usually independent and drawn from appropriate backgrounds, and some, particularly the chair, are experienced. A minimum frequency of meetings is usually agreed, with flexibility for more if needed. The DMC should understand and agree the statistical approach (and guidelines) chosen, with both the DMC statistician and analysis statistician competent to apply the method. A DMC's primary purpose is to ensure that continuing a trial according to its protocol is ethical, taking account of both individual and collective ethics. A broader remit in respect of wider ethical issues is controversial; arguably, these are primarily the responsibility of research ethics committees, trial steering committees and investigators. The DMC should know the range of recommendations or decisions open to it, in advance. A record should be kept describing the key issues discussed and the rationale for decisions taken. Errors are likely to be reduced if a DMC makes a thorough review of the evidence and has a clear understanding of how it should function, there is active participation by all members, differences are resolved through discussion and there is systematic consideration of the various decision options. DMCs should be encouraged to comment on draft final trial reports. These should include information about the data monitoring process and detail the DMC membership. It is recommended that groups responsible for data monitoring be given the standard name 'Data Monitoring Committee' (DMC). Areas for further research include: widening DMC membership beyond clinicians, trialists and statisticians; initiatives to train DMC members; methods of DMC decision-making; 'open' data monitoring; DMCs covering a portfolio of trials rather than single trials; DMC size and membership, incorporating issues of group dynamics; empirical study of the workings of DMCs and their decision-making, and which trials should or should not have a DMC.
Clinical Trials Data Monitoring Committees↗
WISDOM: history and early demise - was it inevitable?
In 1989, the UK Medical Research Council (MRC) agreed that, if feasible, a randomized controlled trial to assess the long-term risks and benefits of hormone replacement therapy (HRT) was a priority. Feasibility work began in 1990 and demonstrated that a large-scale multicenter trial was possible. An application for funding for a main trial was submitted to MRC in 1993 and, after extensive review, funding was released in late 1996. Set-up work for the trial - the Women's International Study of long Duration Oestrogen after Menopause (WISDOM) - began in 1997 with recruitment in 1999. In October 2002, following the early discontinuation of one arm of the US Women's Health Initiative HRT trial, the MRC decided to stop the WISDOM trial. This article, by the principal UK investigators of WISDOM, sets out the background and history of the trial.
Clinical Trials Data Monitoring Committees↗
Role of the Data and Safety Monitoring Committee (DSMC).
The Data and Safety Monitoring Committee (DSMC) is a committee independent of both the Steering Committee (SC) and any sponsor. It advises these bodies on continuation or stopping based upon safety and efficacy considerations. The primary objective is to assure safety for the patients in the trial. Blinding of the DSMC regarding type of treatment is usually avoided. The DSMC is composed of three to five members and should include one or two clinicians knowledgeable in the field of the trial, one or two statisticians and in some situations a pharmacologist and an ethicist. It is important that the members have experience from other trials and have high integrity. Rules for the statistical analyses have to be set up in the beginning of the trial. However, the DSMC cannot rely only upon statistical rules. Information from other sources may cause stopping before the scheduled end of the trial. The DSMC has to check that the overall quality of the data is good. Of special importance is that the Endpoint Committee is current with classification of endpoints. Timing of the DSMC meetings is dependent on several factors: (i) the incidence of events; (ii) the power of the study design; (iii) the effectiveness of the intervention. Legal requirements to report serious adverse events to legal authorities may be taken over by the DSMC, which ideally is the only body that has access to unblinded data.
Clinical Trials Data Monitoring Committees↗
Sample sizes for clinical trials with time-to-event endpoints and competing risks.
We consider clinical trials where the time to occurrence of events in the presence of competing risks is the primary endpoint for treatment evaluation. The number of events with regard to the defined primary endpoint required to ensure the specified power can be calculated according to Schoenfeld's formula like in classical survival studies. However, determination of the number of patients that have to be recruited to observe the calculated number of events requires specification of the length of the accrual period, the trial duration and assumptions about the event-specific hazard functions. Information from previous studies about expected failure rates for the reference treatment is useful and can be translated into assumptions about the appropriate model parameters. A formula for sample size computation is presented for two competing outcome states. Nomograms help to communicate different alternatives of duration and size of the trial to interdisciplinary committees whose members plan and monitor the clinical trial. The 4D trial (Die Deutsche Diabetes Dialyse Studie) designed to compare lipid lowering treatment with HMG-CoA reductase inhibitor atorvastatin with placebo in type 2 diabetic patients on hemodialysis with respect to time to the composite event "cardiovascular death or non-fatal myocardial infarction" is used as an example to outline the statistical methods.
Clinical Trials Data Monitoring Committees↗
Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study.
BACKGROUND: We describe a review of published main reports of randomized controlled trials (RCTs), in order to measure the frequency of reported use of data monitoring committees (DMCs) and factors associated with reported DMC use. METHODS: Twenty-four higher impact general and specialist medical journals were handsearched for main reports of RCTs in order to provide a cross-sectional sample of trials published in the year 2000. Additionally, the same general medical journals were handsearched for 1990 to allow a comparison across time. RESULTS: Of 662 RCTs published in 2000, 120 (18%) explicitly reported using a DMC, while 107 (16%) reported planned interim analyses. Overall, about a quarter (24%) reported at least one of these. A higher proportion of trials reported using a DMC in 2000 than 1 990 (70/282, 25% versus 21/204, 10%) in the general medical journals. Logistic regression models suggested the more important variables associated with increased reported DMC use were: later year of publication, publication in general medical journal, survival-based endpoint, multicentre trial, increasing number of patients recruited, at least one arm involving a placebo, at least one arm involving a drug, factorial design and USA involvement in the trial. CONCLUSIONS: In 2000, about a quarter of main RCT reports mention use of a DMC. Actual use of DMCs is likely to be somewhat greater. Reporting use of a DMC was more likely for larger and longer trials among other factors. We believe the factors affecting reported use affect actual use. It is recommended that when a DMC oversees a trial, brief details should be explicitly included in the main trial paper. Standard nomenclature for DMCs is recommended.
Clinical Trials Data Monitoring Committees↗
Stopping the active intervention: CARET.
The Carotene and Retinol Efficacy Trial (CARET) was a large, multicenter randomized chemoprevention trial designed to test a combined lung cancer prevention agent in heavy smokers and workers exposed to asbestos. In January 1996, the CARET Steering Committee decided to stop the intervention due to an adverse effect. This paper describes the decision process used to apply the stopping rules and the activities engaged in by CARET participants and staff to implement the decision. The most important activity was to draft and mail a letter to the participants informing them of the disappointing CARET results and asking them to stop taking the study vitamins and to return any unused study vitamins. The steering committee, with the support of the National Cancer Institute, planned to follow participants for disease endpoints and smoking behavior for 5 years. These activities led to smooth closure of active intervention and maintained high retention rates during the transition.
Asbestos↗
Data monitoring in randomized controlled trials: surveys of recent practice and policies.
BACKGROUND: Data Monitoring Committees (DMCs) are increasingly involved in the conduct of randomized controlled trials, but there is little documented evidence of what they do. Three interlinked surveys were carried out as part of the DAMOCLES project to explore recent and current DMC practice and policy. METHODS: 1) A questionnaire about DMC practice was sent to sample of 45 authors of trials published in selected journals in 2000. The sample was stratified by centre (single/multiple), disease area, and presence of DMC. 2) A sample of investigators in trials ongoing in the United Kingdom in 2001-02 was also sent a questionnaire about DMC practice. The sample was drawn from trials funded by the Medical Research Council, the United Kingdom Department of Health's Health Technology Assessment Programme, and a local and a multicentre research ethics committee. The sample was additionally stratified by funder (public/industry), centre (single/ multiple), and disease area. 3) A sample of major organisations involved in randomised controlled trials was sent a questionnaire about DMC policies. RESULTS: Information about DMC practice from the first survey was obtained from 31 trials (69%), of which four had a DMC. Information about DMC practice from the second survey was obtained about 36 trials (90%), of which 20 had a DMC. Information about DMC policy from the third survey was obtained from 25 out of 25 organisations. There was general agreement about the sorts of trials particularly needing independent DMCs, but there were few uniform approaches to their modes of functioning, and few of the organisations surveyed had developed formal policies. CONCLUSIONS: The roles of existing DMCs and policies governing DMC functioning vary widely across trials and organisations that sponsor or oversee trials, both within the UK and internationally. These findings reinforce previous calls for development of such policies across a wider range of organisations, better means to monitor their implementation within trials, and wider use of structured "charters", which set out DMC modus operandi in advance. Clinical Trials 2005; 2: 22-33. www.SCTjournal.com
Clinical Trials Data Monitoring Committees↗
Termination of a randomized controlled trial of two vasectomy techniques.
Family Health International (FHI) and EngenderHealth conducted a multicenter, randomized controlled trial to evaluate a fascial interposition (FI) component of a vas occlusion procedure for male sterilization. A data monitoring committee (DMC) was established to provide independent review of the interim report. The DMC met to review the interim report after enrollment of 552 men. As planned, an estimate of the hazard ratio (HR) for successful vasectomy for the FI group versus the no-FI group controlling for age of the participant and level of experience of the surgeon was obtained for the interim report using Cox's proportional hazards regression. The main analysis comparing time to vasectomy success, defined as two consecutive azoospermic semen samples, was highly significant and met the prespecified level for stopping enrollment (HR=1.54, p<0.01). However, a troublesome age by vasectomy technique interaction became apparent in the analysis. FI was clearly beneficial for younger males. However, the trend for older men was not as clear. The DMC recommended continuing the trial to better study this interaction and obtain more data to clarify the effect of FI for older men. After consulting further with the DMC, the study statisticians presented the interim report to senior management at FHI. A meeting between FHI senior management and the DMC followed. After much deliberation, trial enrollment was terminated. Follow-up of participants already enrolled in the study continued as planned. This paper presents the issues involved in the decision to terminate the study.
Age Factors↗
Data monitoring committees for Southwest Oncology Group clinical trials.
A monitoring committee policy was established by the Southwest Oncology Group in 1985 to address documented problems in study conduct. Committees consisting of the study coordinators, disease committee chair, study statistician, Group chair, Group statistician, an uninvolved Southwest Oncology Group clinician, an NCI representative, and a representative from each involved group for intergroup studies have been appointed for each phase III study. Business is conducted largely through the mail and through conference calls. Since then, problems identified in older studies have been largely resolved. Appropriate and timely decisions are being made at modest additional expense to the Group.
Clinical Trials as Topic↗
Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials.
AIMS: To systematically review the published literature on data monitoring committees (DMCs) for randomized controlled trials (RCT) and summarize information and opinions on best practice. This was part of the DAMOCLES project. METHODS: A systematic and comprehensive search of five online bibliographic databases was performed, identifying 4007 potentially relevant articles. These were assessed in two stages by the authors. The 84 most relevant articles were agreed and were supplemented with extracts from 16 books: ultimately, 100 sources were reviewed. A series of 23 questions plus subquestions were developed to structure the data extraction and interpretation process. RESULTS: Much has been written about DMCs but by a rather small community of authors. The papers included some results of surveys, but were mainly opinion pieces based on the authors' beliefs, practices and experiences. There is a lack of empirical evidence for many aspects of DMCs. There was a great range of detail in the literature relating to the prespecified questions. It was generally agreed that interim monitoring of accumulating data was necessary in some form for most trials. Questions such as membership of the DMC featured widely in the literature with opinions and practice ranging from 3-20 members, of whom between none and all should be independent. There was a consensus that formal statistical methods should be used as tools to guide decision making rather than as hard rules. Conversely, topics such as the training and experience required for DMC membership were discussed in very few papers. CONCLUSIONS: There is a consensus in the published literature in a number of areas, although there are many different models for structure and functions of a DMC. While uncertainty remains about some issues, it is strongly recommended that an explicit set of guidelines (Charter) is prepared for each DMC prior to the start of the trial specifying clearly how it will operate.
Clinical Trials Data Monitoring Committees↗
The role of the data safety and monitoring committee in stroke trials.
There are many good reasons why any human experiment should have appropriate oversight. In clinical trials, the data safety and monitoring committee (DSMC) serves to protect the interests of the patients. In stroke trials, its members usually together represent a broad expertise in neurology, internal medicine, cardiology and biostatistics. Independency and integrity are key words, especially in the relationship to the sponsor of the trial. The DSMC members should have no long-term financial strings to the sponsor, and they should not be personally involved in patient recruitment and evaluation. The DSMC provides recommendations to the steering committee of the trial on whether to continue or to stop patient recruitment and on protocol amendments that may be necessary to protect the safety of the patients.
Clinical Trials as Topic↗