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Results for “Clinical Trials Data Monitoring Committees”

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At least 19 recordsLinked to original sources
PubMed1993

Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.

Clinical Trials Data Monitoring Committees↗
PubMed1995

The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials.

The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.

Advisory Committees↗
PubMed1991

Data monitoring committees for multicenter clinical trials sponsored by the National Institutes of Health. I. Roles and membership of data monitoring committees for trials sponsored by the National Eye Institute.

The operational aspects of data monitoring committees for multicenter clinical trials have received little attention in the published literature, in contrast to a wealth of publications concerning the statistical aspects of data monitoring. Occasional anecdotal reports suggest that the role of these committees is complex and that responsibilities and decisions extend beyond choice of a stopping rule. In an effort to gain a better appreciation of the domain of responsibilities shared by all or most of the data monitoring committees (DMCs) for the 20 multicenter studies (30 clinical trials) sponsored by the National Eye Institute, one of the National Institutes of Health, published information was studied and key members of the DMCs for these studies were surveyed. Information about the membership of these important groups also was sought in order to guide those with responsibility for appointing future DMCs. Three tasks--all directly associated with monitoring accumulating data for evidence of benefit or harm to trial patients--were reported unanimously to be the responsibility of the DMCs. In addition, many responsibilities concerned with study oversight rather than data monitoring were assigned to the DMC in 75% or more of the trials. The domain of responsibilities common to a majority of the DMCs suggests that these groups function in most NEI-sponsored multicenter trials as combined data monitoring and policy boards, even when not so designated. The median size of the 20 DMCs was 10 members, with six appointed and four ex officio members. Ophthalmologists accounted for 38% of all DMC positions and statisticians for 33%.

Clinical Trials as Topic↗
PubMed2003

Toward protecting the safety of participants in clinical trials.

It is a widely held belief that the current system of oversight of clinical research, particularly the means of assessing risks and minimizing harms to participants in clinical trials, could be improved. In particular, the system is inefficient with overemphasis on the monitoring ability of some groups such as research ethics review boards and investigators, underemphasis on others such as data monitoring committees (DMCs) and sponsors, confusion about responsibilities for safety and imperfect communication between these different groups. Research ethics review boards are not able to perform safety monitoring by review of individual adverse events and are often burdened by duplicative reviews of large multicenter studies. There are no standards for DMCs to ensure they can reliably identify safety issues. Sponsors may be overreliant on data audits and slow to disseminate safety data in a coherent summary. Investigators, their staffs and clinical sites may not fully appreciate all the nuances of good clinical practice or may be inattentive to the daily conduct of studies. Regulators, particularly those in the United States, have failed to completely harmonize their policies with each other or with international regulatory agencies. We recommend well-designed monitoring plans for all studies that are appropriate to their scope and risk, more centralized review of large multisite studies and closer local scrutiny of single-institution studies. In addition, sponsors should pay greater attention to monitoring adverse events and keeping up-to-date databases or investigator's brochures emphasizing safety issues. A minimal standard of education or expertise in good clinical practice should be established for investigators, their staffs and research ethics review board members. DMC composition and functions should be standardized and regulations should be harmonized nationally and internationally. Finally, there should be a concerted effort to study the efficacy of various components of the system.

Clinical Trials Data Monitoring Committees↗
PubMed2003

Acute stroke: trial by jury. The toothless tiger (role of the principal investigator).

All trials require a principal investigator to take the lead role and act as main contact amongst the various groups of participants. His role ranges from assistance in protocol design; through selection of investigators, monitoring of study conduct and responding to Safety Committee recommendations; to involvement in study reporting and in maintaining access to the data set after the conclusion of the trial. This article describes the role of the principal investigator and Steering Committee in more detail and discusses the issues that arise out of the organisational requirements of modern clinical trials and the potential tensions between the various participating groups.

Acute Disease↗
PubMed2001

Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.

There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.

Clinical Protocols↗
PubMed2003

The scribe of stroke trials.

The responsibility for reports about drug trials in medical journals should lie with the clinicians in the steering committee, not with the industrial sponsor. Examples of undue influence of sponsors on the conduct and analysis are the choice of surrogate outcome events, changes in the protocol during the trial, discontinuation of the study, post hoc analyses and suppression of publication. Since this essay was written, the International Committee of Medical Journal Editors ("Vancouver Group") has issued the condition that authors of submitted manuscripts should guarantee their independence in data analysis and reporting. Nevertheless, this "security check" occurs at a late stage and may not apply to journals that are less well known. Institutional Review Boards should routinely take the matter of independence into account. Also, European guidelines should be rewritten to reflect these fundamental issues rather than a multitude of details. In fact not sponsors or physicians but patients and the general public are the true owners of trial data.

Clinical Trials Data Monitoring Committees↗
PubMed2001

The organization of the Asthma Clinical Research Network: a multicenter, multiprotocol clinical trials team.

Asthma is an increasingly serious cause of morbidity and mortality in the United States, affecting approximately 12 million people, including men and women, children and adults, and all racial and ethnic groups. It is now recognized that asthma is a complex disease of varied etiology triggered by a number of factors such as allergens, drugs, chemicals, exercise, cold dry air, infections, and emotions. Asthma is a chronic disease requiring multiple medications to treat and control symptoms as well as medications thought to control the underlying inflammation. Despite major advances in understanding the etiology and pathophysiology of asthma and the development of new therapeutic modalities, the prevalence, severity, and mortality from asthma have all increased over the past decades in all age groups. Hospitalizations for asthma have doubled in adults and increased fivefold for children over the past 20 years. Mortality appears to be particularly high in urban and rural minority populations. Asthma continues to place a heavy burden on patients and their families as well as the health-care system. In an attempt to respond to the need for well-designed clinical trials to allow rapid evaluation of new and existing therapeutic approaches for asthma and for dissemination of laboratory and clinical findings to the health-care community, the Division of Lung Diseases, National Heart, Lung, and Blood Institute, established the Asthma Clinical Research Network.

Adult↗