There’s no question that your clinical trial must adhere to stringent ethical principles and reflect the foundational principle of medicine – “to do no harm.” Safety monitoring in clinical trials is vital to protect participants, uphold ethical standards, comply with regulations, ensure scientific validity and ensure high quality in research. For this reason, Data Safety Monitoring Boards (DSMB) and Safety Review Committees (SRC) are indispensable.

These committees monitor and respond to participant safety in the clinical trial setting. DSMBs and SRCs provide the rigorous oversight necessary to navigate the complexities and risks associated with clinical trials. DSMBs are independent of the trial operations and typical in later-phase trials. In this article, we will focus on Safety Review Committees, a feature of early-phase clinical trials, especially those requiring decision-making on dose escalation

The role of Safety Review Committees (SRCs)

Safety Review Committees (SRC) are primarily tasked with monitoring participant safety and making decisions regarding trial progress. Where an early phase trial has dose-escalating cohorts, or single and multiple dosing formats, the SRC will meet regularly to review data and agree (or not) that the trial can progress.  They review and discuss safety data, adverse events, and pharmacokinetic data.  The SRC recommends necessary modifications to the trial protocol to protect participants. SRCs operate throughout the trial and convene ad hoc in case of safety concerns.

A misconception is that SRCs are the same as Data Safety Monitoring Boards (DSMBs). While similar, DSMBs are typically established for later phase 2 and phase 3 trials. The DSMB must be independent of the trial operations and are less likely to make continuous protocol-driven decisions. Instead, a DSMB will review accumulated safety-related data over time and make recommendations regarding the continuation of the trial per protocol. The SRC and DSMB can determine whether a trial should continue, be modified or stopped altogether. Both DSMBs and SRCs can put a trial on hold while they seek further information on which to make decisions.

The importance of SRCs and DSMBs

The primary function of both the SRC and the DSMB is to safeguard trial participants. Safety Review Committees review and discuss safety data and adverse events in real time, taking immediate action as necessary and ensuring the trial progresses in an informed manner. This proactive approach minimizes risks to participants. Meanwhile, DSMBs offer an unbiased evaluation of a trial's progress, free from the influence of sponsors or investigators. This independence is crucial for maintaining your trial's integrity.

By ensuring that trials adhere to ethical and reporting standards, SRC and DSMB help build public trust in clinical research, which is essential for participant recruitment and retention. Moreover, these committees ensure that your trial complies with regulatory requirements while avoiding potential legal and ethical issues arising from non-compliance.

Composition of SRCs

A typical SRC includes senior members of the trial team and often at least one independent member, who is not working directly on the trial.  There may be voting and non-voting members of the SRC, and a Chair for the committee is assigned.  All SRC members, voting and non-voting, are required to bring their expertise to the table during discussions.

• Project Manager (PM): The PM may coordinate the SRC’s activities, including scheduling meetings, setting agendas, ensuring correct data is provided, documenting the meeting, including discussions and decisions, and implementing follow-up actions. Their organizational skills and knowledge of the trial operations are vital for the committee's efficiency.
• Medical Monitor: The Medical Monitor assigned to the trial will be a key SRC member.  The Medical Monitor is an experienced clinician who provides expert opinion on the clinical status of trial participants. They review adverse events and safety data, offering insights based on their clinical expertise.
• Principal Investigator (PI): The trial PI or PIs are key members of the SRC.  The PIs bring to the discussions the journey of each participant in the trial to date.  They present each participant and highlight any individual adverse events or noted trends.
• Pharmacokineticist: If pharmacokinetic data is available that informs decisions of the SRC then a Pharmacologist or Pharmacokineticist may be part of the SRC.

How Southern Star Research can help manage SRCs

Southern Star Research has a proven track record in managing and working within SRCs, leveraging our expertise to ensure the highest standards of practice throughout your clinical trial. Our experienced PMs will ensure all committee members are aware of their roles and responsibilities and informed with data throughout the active participant phase. Our Medical Monitor has many years of experience as an active trial SRC member and an independent SRC member. They perform rigorous data reviews and work closely with the PI and Sponsor to ensure timely and accurate assessments.

Safety Review Committees are vital to early-phase clinical trial processes and oversight. They ensure that your trial is conducted safely, ethically, and efficiently. By understanding the role of SRCs, we can better appreciate the complexities and safeguards of early-phase clinical trials, ultimately fostering greater trust in the medical research process. If you want to learn more about how you can successfully navigate clinical research in Australia with a team of professionals who are committed to safe and ethical studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.