The Role and Purpose of Clinical Trial Monitoring

Clinical trial monitoring is a crucial aspect of clinical trial conduct, confirming that the rights of the participants are protected and that their well-being is maintained. In addition, monitoring also ensures that the data gathered during the trial is accurate, complete, and can be verified from any source documents.

In this article, we will discuss the role and purpose of clinical trial monitoring, including its different types, and how participants can benefit.

What is the purpose of clinical trial monitoring?

Clinical trial monitoring is important for a range of purposes, ensuring everybody involved in the trial is protected and that the trial achieves the best possible results.

Clinical trial monitoring helps to ensure:

• All rights of the participants are protected, including their general well-being.
• The reported trial data is accurate and complete, and can be verified from the source documents. The source documents include any records relating to clinical findings, observations, and any other activities that take place during the trial.
• The trial’s conduct complies with Good Clinical Practice (GCP) and adheres to protocols and any applicable regulatory requirements.

Types of clinical trial monitoring

There are four main types of clinical trial monitoring, with both on-site and off-site monitoring taking place to ensure all aspects of the trial are fully compliant and are being completed to the required standard. The four types include on-site monitoring, remote monitoring, centralized monitoring and risk-based monitoring.

On-site monitoring

On-site monitoring involves the assessment of clinical trial procedures at the site(s) of the trial. This type of monitoring is carried out in person, by the sponsor or their representatives who will oversee the trial’s processes on location. This is the most typical form of monitoring and it is most suitable for clinical trials that take place at a centralized location.

The downside to on-site monitoring is that it is sometimes not viable or cost-effective to conduct in-person assessments if the trial is spread across multiple sites that are not in close proximity.

Remote monitoring

Remote monitoring evaluates the clinical trial or study off-site and became more prevalent during the COVID-19 pandemic when on-site visits were restricted or prohibited for safety reasons. Remote monitoring removes any risk for assessors (e.g. if the trial involves participants who may have a contagious disease) and helps to reduce costs.

Remote monitoring is common in decentralized clinical trials (DCTs) and uses technology to provide stable communication between the clinical trial site and the sponsor, allowing messages to be shared, notifications to be sent, and providing constant access to necessary information on a single platform.

Centralized monitoring

Centralized monitoring takes place at a central location away from the site of the clinical trial, in a similar way to remote monitoring. However, centralized monitoring differs in that it takes place at just one location, reducing costs and creating a more efficient process.

Data is assessed once it has been submitted to the centralized location, allowing monitoring personnel to evaluate the findings and identify any gaps or inconsistencies. This is then followed by mitigation processes to rectify the inaccuracies.

Like remote monitoring, centralized monitoring ensures the safety of individuals as monitoring personnel are not required to be on-site, avoiding any risks such as additional human interference.

Risk-based monitoring

Risk-based monitoring (RBM) focuses on the potential risks that the clinical trial could present, assessing the quality of processes relating to the investigation itself, the participants, the integrity of the data, and other associated risks. This monitoring also dictates what other types of monitoring will be used, whether that is on-site, centralized, or remote.

RBM can be broken down into 4 main stages:

• Identifying any potential risks relating to the trial
  Creating a clinical trial monitoring plan
  Amending the methods and processes of the trial if necessary
  Determining what type of monitoring is suitable for the trial

Specific roles and responsibilities involved in clinical trial monitoring

When it comes to clinical trial monitoring, there are a number of different roles and responsibilities that ensure the assessment is a success. The size of the clinical trial monitoring team and the individuals that are required depends on the type of trial, its duration, and the number of participants.

Below is an overview of the different roles that make up a clinical trial monitoring team.

Principal Investigator (PI)

The principal investigator (PI) is charged with governing the conduct of the clinical trial, with a broad range of responsibilities that include safety and risk evaluation, the study type, its design, monitoring, reporting, and organizing collaborative care.

As the trial’s lead figure, the PI will work with the Institutional Review Board (IRB)/ Independent Ethics Committee (IEC), manage the investigation and its protocol, maintain study records, and supervise staff. In addition, the PI also leads the recruitment of participants and obtains informed consent.

This is a critical and demanding role, enabling communication between all parties involved in the trial, from the participants to the review board.

Clinical research associates & clinical research coordinators

Clinical research associates (CRA) and clinical research coordinators (CRC) are key roles in clinical trial monitoring. They are employed by the sponsor directly or by the trial’s Contract Research Organization (CRO).

CRAs are responsible for hosting large numbers of participants across numerous sites, visiting each trial site on a regular basis to review documentation and ensure compliance in terms of protocol and sponsor standard operating procedures (SOPs).

CRCs assist the PI during a clinical trial, performing tasks such as recruiting participants, reviewing their eligibility, planning subject visits, and other tasks that can ensure the clinical trial goes smoothly. Like CRAs, CRCs also collect and maintain clinical documentation to ensure the integrity of data and compliance.

Study physicians

Many clinical trials require a study physician, although sometimes the PI performs this duty. A study physician or clinical trial physician has two main roles, overseeing the medical needs of participants and providing feedback to the sponsor regarding the experience of the participants.

Study physicians are key to maintaining the safety and well-being of anyone participating in the trial, reporting any medical details or decisions made regarding a participant’s condition during the trial. Reporting may include any adverse effects, treatment adjustments, medical history, genetic profiling, lifestyle factors, and more.

Study nurses

Clinical trial/ study nurses are vital to the success of the trial, particularly during the therapeutic pipeline, identifying any potential risks that could impact the safety of an individual. Nurses are responsible for administering the treatment or drug, and are the first point of contact for the patient, offering assistance if there are any issues or adverse effects.

Study pharmacists

Study pharmacists focus on medication, identifying drug interactions during the trial to determine the optimal dose and medication course for participants to ensure a successful study.

Participant's role in clinical trial monitoring

The participant is equally as important as any member of the clinical trial monitoring team when it comes to achieving the desired results. Participants must be willing to engage and communicate with staff, providing honest feedback to maintain the integrity of the trial.

For a participant to play a pivotal role in the success of a trial, they must understand what is expected of them and how they can benefit from taking part in a study.

What participants can expect during monitoring

Clinical trial monitoring, with the cooperation of study participants, can ensure the process is engaging and provides a level of interactivity that leads to a rewarding experience.

Participants will be asked to:

• Actively communicate with the study nurses and other members of the monitoring team to maintain a constant dialog and build rapport. Open communication also allows participants to voice any issues if they feel their rights are in question, or if they have any concerns about the study.
• Review documentation such as consent forms and provide ongoing feedback about their condition, giving monitoring staff a better understanding to determine the effectiveness of the drug or treatment.
• Report any adverse effects as soon as possible, especially any sudden changes in their health or well-being to prevent potential serious or long-term conditions or side effects.
• Once the trial has ended, participants may also be invited to follow-up meetings to discuss their overall experience and offer insights into how future studies could be improved.

How participants benefit from effective monitoring

Compliance and adherence to regulations set out by the review board are at the forefront of clinical monitoring, however, monitoring is also essential for the safeguarding of participants. Effective monitoring assesses the health and well-being of each individual, and without it the study loses its integrity. Insufficient monitoring could also mean the results of the clinical trial are invalid.

The three key benefits of effective clinical trial monitoring are:

• Safety Assurance - Monitoring provides assurances that safety protocols are being followed to the letter. This protects participants so they are subjected to minimal risk, with their health and well-being being a priority.
• Validity - Monitoring increases the validity of the study results to provide more effective treatments, based on more reliable and accurate data. The correct level of monitoring ensures medical interventions are being evaluated in the right way, resulting in improved studies in the future.
• Preventing misconduct or fraud - The clinical trial monitoring team acts as an external evaluation of the study, making sure all individuals are adhering to protocol and ethical standards. This significantly reduces the chances of misconduct, malpractice, or fraud being committed.

The future of clinical trial monitoring

Clinical trial monitoring is constantly changing to improve processes and achieve better results. These improvements are assisted by changes in technology, helping to create more effective solutions in terms of remote monitoring. Monitoring also needs to be centered around the participant to be completely effective, which is why the latest technological advancements are being utilized to create a better user experience.

Technology such as artificial intelligence and machine learning are being incorporated into modern clinical trial monitoring for faster and more accurate data analysis. AI can identify any anomalies in the data so it can be reviewed and corrected.

Meanwhile, wearable devices can play a key role in maintaining the well-being of the participant, monitoring a range of bodily functions to check if the individual’s condition is normal, such as their heart rate or blood sugar levels. Thanks to technology such as this, a participant-centric approach can be developed, making it easier for participants to communicate effectively and provide valuable feedback.

Conclusion

It is clear that monitoring is a crucial component of clinical trials and studies, as without effective monitoring the results of the trial would be deemed invalid. Adhering to regulations, and protocols, and ensuring compliance is a key part of monitoring, but more than that, it is important to protect participants, safeguarding their health and well-being.

By implementing new technology, clinical trial monitoring is expected to improve and become more participant-centric, with wearable devices providing real-time feedback and artificial intelligence contributing to more accurate data.