Data And Safety Monitoring Committees In Clinical Trials

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The overall goal is for the interval between current data and the DMC meeting to be as short as possible. Figure 1 below is a scenario of the chronological order of deadlines set before a DMC meets. Figure 1. The above represents a possible scenario of chronological deadlines in a trial with a DMC in place.

Comprehensive Data Monitoring Committee Services

Monitors may need to accelerate data retrieval so that it can be processed in time for the DMC. Scheduled and designated timelines mean that monitors will potentially have more issues to manage within a limited time.

Promoting Statistical Insight

Monitors may need to plan visits according to these deadlines, assure query resolution, complete source document verifi cation, and request that the site fax the most current information on forms that track cumulative information, such as adverse events or concomitant medications knowing that these will still require future source document verifi cation C.

Monitors will need to determine which sites require more of their attention and prioritize follow-up activities. These sites may include those with less experience, those historically delinquent in meeting deadlines, those with a signifi cant amount of queries, or those with high enrollment C. Tyner, personal communication, February 18, ; A.

Hosfeld, personal communication, February 20, References : A. Hosfeld personal communication, February 20, C. FDA Docket No.

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What Does it take to Remember Informed Consent? All clinical investigations, including physiologic, toxicity, and dose-finding studies phase I ; efficacy studies phase II ; efficacy, effectiveness and comparative trials phase III , involving greater than minimal risk to participants i.

Data Safety & Monitoring Board (DSMB) Establishment

The method and degree of monitoring needed is related to the degree of risk involved. A Data Safety Monitoring Board DSMB is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the study is unlikely to be concluded successfully. Risk associated with participation in research must be minimized to the extent practical.

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Clinical Trial Data Safety Monitoring Board (DSMB) - EUPATI

Monitoring should be commensurate with size and complexity of the study. Monitoring may be conducted in various ways or by various individuals or groups, depending on the size and scope of the research effort. A data monitoring committee DMC — sometimes called a data and safety monitoring board DSMB — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.

Many randomized clinical trials are double blind — no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized. Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results.

The DMC is a group typically 3 to 7 members who are independent of the entity conducting the trial. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. Ethicists or representatives from a patient advocacy group may be included, particularly for research involving vulnerable populations. The DMC will convene at predetermined intervals depending on the type of study to review unblinded results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.

The primary mandate of the DMC is to protect patient safety.

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If adverse events of a particularly serious type are more common in the experimental arm compared to the control arm, then the DMC would have to strongly consider termination of the study. In many cases, the experimental arm could cause serious adverse events chemotherapy, for example , but the resulting improvement in survival outweighs these adverse events. In the fortunate situation that the experimental arm is shown to be undeniably superior to the control arm the DMC may recommend termination of the trial.

This would allow the company sponsoring the trial to get regulatory approval earlier and to allow the superior treatment to get to the patient population earlier.