Data Monitoring Committees
Encyclopedia
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.
However, these trials may go for years and there is justifiably concern about enrolling participants and exposing them to an unproven treatment without someone overseeing results. The company sponsoring the trial is blinded, so they can't perform this service. Even if they had some people who were unblinded to the results, they would be in an awkward position between concern for their corporate interests and concern for the trial participants.
The DMC is a group (typically 3 to 7 members) who are independent of the company sponsoring the trial. At least one DMC member will be a statistician
. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects (e.g. nephrology
, cardiology
). A few long, visible trials may include an ethicist or even a representative from a patient advocacy group. The DMC will convene at predetermined intervals (three to six months typically) and review unblinded results, i.e. results split by experimental and control arms. The DMC has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.
s 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. This evaluation has to be made in consideration of risk/benefit. In many cases, the experimental arm could cause serious adverse events (chemotherapy, for example), but the resulting improvement in survival outweighs these adverse events.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
is ongoing.
Need for a DMC
Many randomized clinical trials are double blind, i.e. no one involved with the trial knows what treatment was given to the trial participant. This includes the participant, their doctor, and even the study personnel at the company that is sponsoring the trial. There are many extremely good reasons to conduct a trial in this manner and only after the trial database is finalized is the blind broken and the true treatment assignments disclosed.However, these trials may go for years and there is justifiably concern about enrolling participants and exposing them to an unproven treatment without someone overseeing results. The company sponsoring the trial is blinded, so they can't perform this service. Even if they had some people who were unblinded to the results, they would be in an awkward position between concern for their corporate interests and concern for the trial participants.
The DMC is a group (typically 3 to 7 members) who are independent of the company sponsoring the trial. At least one DMC member will be a statistician
Statistician
A statistician is someone who works with theoretical or applied statistics. The profession exists in both the private and public sectors. The core of that work is to measure, interpret, and describe the world and human activity patterns within it...
. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects (e.g. nephrology
Nephrology
Nephrology is a branch of internal medicine and pediatrics dealing with the study of the function and diseases of the kidney.-Scope of the specialty:...
, cardiology
Cardiology
Cardiology is a medical specialty dealing with disorders of the heart . The field includes diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology...
). A few long, visible trials may include an ethicist or even a representative from a patient advocacy group. The DMC will convene at predetermined intervals (three to six months typically) and review unblinded results, i.e. results split by experimental and control arms. The DMC has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.
Safety concerns
The primary mandate of the DMC is to protect patient safety. If adverse eventAdverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
s 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. This evaluation has to be made in consideration of risk/benefit. In many cases, the experimental arm could cause serious adverse events (chemotherapy, for example), but the resulting improvement in survival outweighs these adverse events.
Overwhelming benefit
In the rare, but 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. There are cautions here though. The statistical proof needs to be very high indeed. Also, there might be other reasons to continue, such as collecting more long-term safety data.Futility
Futility is not as widely recognized as safety and benefit, but actually can be the most common reason to stop a trial. As an example, suppose a trial is one-half completed, but the experimental arm and the control arm have nearly identical results. It's likely in no one's interest to have this trial continue. It is extremely unlikely that the trial, should it continue to its normal end, would have the statistical proof needed to convince a regulatory agency to approve the treatment. The company sponsoring the study could save money for other projects by abandoning this trial. Also, current and potential trial participants could be freed to take other treatments, rather than this experimental treatment which is unlikely to benefit them.See also
- Clinical monitoringClinical monitoringClinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials...
- Clinical trial protocolClinical trial protocolA clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
- Institutional Review BoardInstitutional review boardAn institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- PharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...