<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
blog-hero.jpg
Compliance In Focus
Posted by Rachel Silver-Kessler on Tue, Feb 13, 2018

Safety Oversight Options

A safety monitoring group may be called many different things— a data monitoring committee, Safety Oversight.jpga data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study risks.

Medical device sponsors, according to 21 CFR 812.40 and 812.46, are responsible for monitoring clinical trials.  The regulations require that sponsors monitor a trial at a site by ensuring that an investigator is compliant with the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth in the approval of the study by the IRB.  It is also the responsibility of the sponsor, according to 21 CFR 812.43(d) to select monitors qualified by training and experience to monitor a study in accordance with 812 and other applicable FDA regulations. Sponsors may also appoint other individuals and groups to ensure compliance and proper clinical trial monitoring as well as evaluate the accumulating outcome data.

The FDA guidance, The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors, defines a Data Monitoring Committee (DMC), also known as Data Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs), as a group of individuals with pertinent expertise that reviews, on a regular basis, data from one or more ongoing clinical trials. Other safety oversight options include a Clinical Events Committee, or CEC, or a Medical Monitor. What’s the difference? Take a look at the information below to learn more about the purposes, types of information reviewed, and when each option is most useful in a clinical study.

DSMB

Can assess continuing safety of the trial subjects and those yet to be recruited, and provide continuing validity and scientific merit of the study.

Type of Information Reviewed:

  • Cumulative rates of adverse events, endpoints, or other study metrics to date
  • Detailed case summaries for notification or stopping events

When They Are Most Useful:

  • Large, randomized, multi-centered trials
  • Industry-sponsored trials with mortality or major morbidity endpoints
  • When there are concerns from an IRB regarding safety in multi-center trials
  • Higher risk, complex studies/products

CEC

Can review important endpoints reported by the investigators to determine if they meet protocol-specific criteria.

Type of Information Reviewed:
  • Relatedness and seriousness of adverse events
  • Imaging data
  • Autopsy reports
  • Lab reports
  • Case Histories

When They Are Most Useful:

  • When endpoints are subjective, require the application of a complex definition, or when the intervention is not blinded
  • Help to ensure that data reviewed by other committees are accurate and as free of bias as possible
  • To strengthen data analysis

Medical Monitor

Can provide both medical/educational expertise and trial specific knowledge and experience to the study.

When They Are Most Useful:

  • Any information that DSMB or CEC reviews
  • Regulatory reports
  • Clinical study reports
  • CRFs
  • Development plans
  • Protocol

Type of Information Reviewed:

  • When study designs become more complex (Phase III/IV with numerous sites, etc.), someone with a “big picture” view helps assess study-wide concerns
  • To provide additional  safeguards for subject  protection and trial continuity

If you are wondering if a DSMB and CEC could be combined, see our blog on the topicWhat types of studies have you been involved with that utilized a DSMB, CEC, or Medical Monitor?

New Call-to-action

photo credit: U.S. Pacific Fleet 180114-N-HT134-007 via photopin (license)

Topics: FDA, Safety Monitoring Oversight

imarc

Posts by Topic:

All