Clinical trials are tightly controlled studies that follow several sets of rules and regulations to protect the rights of and help ensure the safety of participants. The U.S. Food and Drug Administration (FDA) sets requirements for clinical trials that take place in the United States or that receive U.S. federal funding. Clinical trial sponsors—typically pharmaceutical companies or institutions—create committees and boards to monitor and enforce these safety requirements.
Clinical trial sponsors may also hire outside monitors to check on clinical trial sites and make sure protocols are being followed to collect necessary data. Ultimately, these data help ensure that new drugs, medical devices, and procedures are safe and effective.
In this article, we’ll break down the different mechanisms used by clinical trial staff to monitor the safety of participant research studies.
Types of Clinical Trial Monitoring
There are three main types of clinical trial monitoring that are based on where monitoring activities take place.1
On-site monitoring occurs on location at clinical trial sites. This type of monitoring may be done by a trial manager or an independent clinical trial monitor (CTM) hired by the sponsor. Most phase 1 clinical trials have constant on-site monitoring of participants to check that data are accurately collected. For phase 2 trials and beyond, on-site monitoring may only occur at certain intervals during a study.
Centralized monitoring occurs at a central location apart from the clinical trial site. The monitoring team may meet at regular intervals to review safety data, protocols, and forms used during a study. All information reviewed is uploaded online so that the monitoring team can access it outside the clinical trial site.
Remote monitoring in clinical trials is similar to centralized monitoring, but the activities occur separately rather than with one centralized team and/or location.
Risk-Based Monitoring in Clinical Trials
You may also hear of risk-based monitoring (RBM), which helps look for any potential risks to participant safety or the quality of data collected during a study. By identifying anything that may interfere with a study sooner rather than later, investigators can be better prepared for situations as they arise.2
RBM uses real-time data and analysis so that trial investigators can quickly make changes as needed. For example, if monitoring done before a clinical trial indicates that participants may become sick from an experimental drug if the dose is too high, the investigators then create a plan to lower the dose if participants begin experiencing certain symptoms.
If they begin the study and find that participants are indeed getting sick, they’re able to react quickly and change the study. RBM can help keep participants safe and prevent adverse events (unintended or unwanted side effects or physical or psychological injuries).
Who Monitors Clinical Trials?
The institutional review board (IRB) is responsible for reviewing certain aspects of a clinical trial (participant recruitment, informed consent forms, etc.). Once these aspects are approved, the IRB meets at frequent intervals to check in and ensure standards are still being met.
However, the IRB doesn’t conduct any site visits, meet with participants, look at data, or monitor for adverse events. As a result, clinical trials require additional monitoring throughout the study to ensure that investigators are following protocols, collecting needed data, and working to keep participants safe.
There are three main monitoring entities — Trial Steering Committees, clinical trial monitors, and Data and Safety Monitoring Boards.
Trial Steering Committees (TSCs)
Trial Steering Committees (TSCs) are put in place to supervise the clinical trial and provide advice as needed.1 Ultimately, the TSC makes the decision to continue or end studies as they see fit. These committees are typically made of:
- An independent chairperson
- One or two principal investigators (doctors/scientists in charge of a clinical trial)
- Two independent members
- A statistician
- A trial manager
Clinical Trial Monitors (CTMs)
CTMs are people hired by sponsors that have extensive clinical and/or scientific knowledge about a study.3 They meet regularly with investigators to go over protocols and check that data are being properly collected.
CTMs also make sure that investigators and study staff are following the International Conference of Harmonization Good Clinical Practices (ICH GCP), an international ethical standard for scientific research.4 They review all essential documents to check that they’re up to date and follow ICH GCP guidelines. Investigators are required to fill out case report forms that record all information about a participant during a study.5 CTMs compare case report forms with patient diaries, hospital files, and other sources to ensure the information is accurate.
In clinical trials that are testing new drugs or procedures, there’s always a risk of an adverse event. Investigators are required to report any adverse events; CTMs ensure the reports are recorded properly and that none were missed.
Finally, CTMs travel to clinical trial sites to meet with investigators and clinical trial staff in person. They ensure that the investigational drug used during a study is stored properly and that it’s being used according to the clinical trial protocol.
Once they complete all of their monitoring activities, CTMs then create a monitoring visit report to give to the sponsor. This report details all of their findings along with any actions that need to be taken to ensure the clinical trial is meeting ethical and safety standards.
Data Safety Monitoring Board (DSMB)
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A Data Safety Monitoring Board (DSMB) is a committee of experts outside of an institution that monitors clinical trial safety and reviews the data collected. Specifically, they look at any serious adverse events that have occurred during a trial to determine whether a treatment is safe.6
For example, a clinical trial is studying a new drug to help treat lung cancer. Participants are divided into two groups — one group receives standard chemotherapy, and the other receives the new drug. If the new drug group’s cancer continues to get worse, or if they become extremely sick from the drug, the DSMB will likely make the recommendation to end the study early.
DSMBs are also responsible for:
- Ensuring data collected are high quality and complete
- Checking in with individual clinical trial sites to make sure investigators are following protocols
- Making sure the clinical trial is recruiting and retaining enough participants
- Checking for any violations in protocol or breaches in participant confidentiality
- Learning the latest research that may affect participant safety
After reviewing all the data from a clinical trial, they’ll make recommendations to the TSC. For example, the DSMB may suggest updating protocols — or in cases where investigators can’t recruit or keep enough participants, ending the study.
Summary
In the United States, clinical trials are highly regulated studies that follow several sets of safety rules and regulations. Investigators and sponsors work with monitors, safety boards, and committees to ensure their studies are meeting requirements. Clinical trials rely on volunteers giving their time and energy to the advancement of science, and adequately monitoring these studies helps ensure that participants’ rights are protected and their safety is prioritized.
