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Results for “Clinical Trials Data Monitoring Committees”

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At least 109 records · Page 6Linked to original sources
PubMed2006

[What happened during these 12 years since CPT-11 was launched in Japan ?].

CPT-11 (irinotecan hydrochloride, trade name: Campto or Topotecin) was launched in 1994. L-OHP (oxaliplatin, trade name: Elplat) was approved based on the fast track evaluation system and launched in 2005. Originally, both of these drugs were synthesized in Japan. Just after the launch of CPT-11, the severity of its toxicity was reported more frequently than its efficacy, therefore it spent much time to spread the use of this drug. As for L-OHP, the approved regimen is FOLFOX in spite the regimen was not actually studied in its registration studies in Japan. However, L-OHP is widely used after its launch. Thus, we find a progress in terms of regulatory system to introduce the widely accepted standard chemotherapy to the Japanese practice sites rapidly. We also find a further understanding for cancer chemotherapy in Japanese society. Recently, mass media reported cancer patients who were eager to receive the standard chemotherapy and requesting the regulatory authorities its quick approval. We have never seen such a scene 10 years ago. These patients' activities could be a key factor to change the infrastructure of cancer therapy.

Antineoplastic Agents↗
PubMed2004

Small group processes relevant to data monitoring committees in controlled clinical trials: an overview of reviews.

BACKGROUND: The quality of the decisions reached by data monitoring committees (DMCs) is crucial. The aim of this paper is to identify factors that may make errors more or less likely in small, task-oriented, decision-making expert groups and to consider the implications of these factors for data monitoring committees. METHODS: A systematic overview was carried out of reviews of empirical studies of small group processes and decision errors in small, task-oriented decision-making groups in laboratory or real-world settings, published between 1950 and 2002 (n = 57 included reviews). RESULTS: These reviews suggest that a number of factors may increase the likelihood that small groups will make poor and potentially erroneous decisions. The most important of these, in terms of empirical support, are: biased or overly directive leadership, expression of a limited range of opinions during group discussion, poor procedures for identifying or appraising the available information, and presentation of the available information in a way that is likely to result in biased perception of it. CONCLUSIONS: The main implications for DMCs relate to membership, the role of the chairperson, the information provided for DMCs and training for DMC members. Selection methods that encourage a degree of diversity within the DMC are recommended. Chairs of DMCs should be experienced members, who have the skills to facilitate a discussion, can manage conflict effectively and can be impartial. Adherence to a prespecified analysis plan is recommended to reduce the risk of error associated with strong evidence or excess information. Training in the use of methodical decision-making procedures, education about the factors that influence decision quality and an opportunity to participate in mock DMC discussions may be of benefit for new members.

Clinical Trials Data Monitoring Committees↗
PubMed2004

A major trial needs three statisticians: why, how and who?

The statistical and scientific integrity of a major clinical trial is enhanced by having three distinct statistician roles: the Study Statistician, the Data Monitoring Committee (DMC) Statistician and the Independent Statistician. In any specific trial, careful attention should be given for selecting the right people to perform these tasks effectively. It is important that there are good communications amongst all three statisticians (and between each statistician and the other trialists) while preserving all confidentiality as regards interim results. Specifically regarding the Independent Statistician, it seems appropriate that they be truly independent having no other trial involvement than producing interim reports that inform the DMC (and be not employed by a commercial sponsor) but at the same time be fully aware of the trial protocol, objectives, organization and database.

Clinical Trials Data Monitoring Committees↗
PubMed1997

Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute.

PURPOSE: To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials. DESIGN: We review the necessity for interim monitoring of outcome data during the course of randomized clinical trials and summarize the reasons for establishing DMCs with requisite expertise and with appropriate independence from study investigators. RESULTS: The important components of the policy for cooperative group DMCs are described with a focus on the makeup of these bodies and on the complementary roles of study committee leadership and DMCs in protecting patient safety during the conduct of randomized clinical trials. CONCLUSION: The cooperative group DMCs that are independent of the study committees and that have the requisite expertise to examine accumulating data and to base decisions on monitoring guidelines that are specified in advance by the study committee provide a body able to protect patient safety, to protect the integrity of the clinical experiments on which patients have consented to participate, and to assure the public that conflicts of interest do not compromise either patient safety or trial integrity.

Humans↗
PubMed2002

Monitoring clinical trials: issues and controversies regarding confidentiality.

During phase III clinical trials in life-threatening disease settings, it is important to ensure that the Data Monitoring Committee (DMC) has exclusive access to the interim efficacy and safety data generated by the data analysis centre, in order to minimize the risk of widespread prejudgement of unreliable trial results based on limited data. This prejudgement could adversely impact rates of patient accrual, continued adherence to trial regimens and ability to obtain unbiased and complete assessment of trial outcome measures. This also could result in publications of early results that might be very inconsistent with final study data on the benefit-to-risk profile of the study interventions. Circumstances arise only rarely in which unblinding of interim data beyond the DMC would enhance the ability of the trial to provide reliable results. However, to address the ethical imperative to protect the interests of study participants, the DMC itself should have access to unblinded efficacy and safety results.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Current controversies in data monitoring for clinical trials.

This article presents some real-life challenges faced by clinical trial Data Monitoring Committees (DMCs), with the aim of clarifying some of the controversial issues that relate to both statistical stopping boundaries and DMC decision-making. Specific attention is given to what constitutes a sensible statistical boundary for stopping a trial early for benefit, bearing in mind that one usually needs proof beyond reasonable doubt of a treatment benefit sufficient to alter future clinical practice. Appropriate choices of stopping boundary for harm and futility are also discussed. The examples serve to illustrate that the practicalities of DMC decision-making require wise judgements based on a totality of evidence, making any statistical boundary just an objective guideline rather than a definitive stopping rule.

Clinical Trials Data Monitoring Committees↗
PubMed2004

Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?

It has long been a fundamental principle of clinical trials that interim comparative data should be kept confidential, with such data accessible only to a small number of individuals responsible for its analysis and monitoring. The rationale for keeping investigators and sponsors blinded to interim data has been extensively discussed, but the possible conflicts of interest that could arise for the statistician who performs the analysis of the interim data and presents it to a data monitoring committee has received little attention. We describe these potential conflicts, and the advantages and disadvantages of approaches that might be taken to minimize them. We have invited commentary on this issue from several statisticians with substantial experience in clinical trials and interim data monitoring.

Clinical Trials Data Monitoring Committees↗
PubMed1993

The use of data monitoring committees in Canadian trial groups.

Following a brief overview of the funding and structure of clinical trials research in Canada, experience with data monitoring committees (DMCs) in four clinical trials organizations is reviewed. Whether committees are required, their mode of selection, composition, degree of independence, mandate and reporting relationships have varied substantially among the groups. Overall the Canadian experience with DMCs has been representative, although formalization of the role of these committees has not proceeded as far as it has in some US agencies.

Canada↗
PubMed1999

The agonising negative trend in monitoring of clinical trials.

Randomised clinical trials are undertaken in the hope of showing positive benefits of a new treatment, but on occasion quite the opposite trend can occur, If the interim data suggest possible negative (harmful) effects of a new treatment. The handling of such emerging negative trends is among the most complicated and ethically challenging scenarios in monitoring clinical trials through repeated interim analyses. Statistical methods are helpful to detect the point of no likely beneficial effect, and the point that separates neutral results from harmful results. However, in practice the decision whether (and exactly when) to stop such a trial involves a complex of other issues that depends on the context of the disease, the treatment being assessed, and the current practice of medicine. Owing to this complexity, an Independent Data and Safety Monitoring Board (DSMB) is best suited to deal with such a situation. Prediction of whether a negative trend will emerge in any trial is not possible. Negative trends were not anticipated in the cardiovascular trials and the trials of lung-cancer prevention described here. In the light of these experiences, all trials and their DSMBs should consider ahead of time the possibility of unexpectedly harmful results, and should document appropriately the statistical guidelines and the decision-making process required to cope with such undesirable events.

Advisory Committees↗