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Understanding Types of Monitoring to Develop a Medical Monitoring Plan for Clinical Trials

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Medical Monitoring Plan

An effective medical monitoring plan for clinical trials is vital when providing cro medical trial consulting research services. It ensures that procedures are safe and consistent for every participant in the cro medical trial. As a result of stringent quality checks of the procedures involved, the data collected is credible and of a high quality.

Regardless of the location of the trial site, the importance of a medical monitoring plan for clinical trials does not change and requires careful consideration.

Responsibilities in Medical Monitoring Plan for CRO Clinical Trials

Before developing a medical monitoring plan for clinical trials it is important to understand the several roles and responsibilities which need to be considered and delegated when conducting clinical trials.

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The responsibility for ensuring a trial is properly monitored, generally lies with the sponsor. The actual monitoring can be done by the sponsor directly or through a delegated authority.

Monitoring procedures are required to be detailed in a Standard Operating Procedure (SOP) as this allows for a clear definition of staff responsibilities. An external audit can supplement the internal monitoring in the beginning stages of the trial if required.

There are several ways for monitoring a Contract Research Organization medical clinical trial including off‐site monitoring through committees, central monitoring, statistical monitoring and also on-site procedures. The level of monitoring will depend on the risk and will be raised if the risk appears to be higher.

Monitoring for Oversight by CRO Medical Trial Committees

Committees can be set up to oversee a cro medical trial depending on the complexity of the trial.

For example, a trial steering committee comprising an independent chair, a maximum of two additional members, a trial manager, statistician and two investigators can be set up. The role of the Trial Steering Committee is to provide supervision and advice on whether the trial should be continued.

In a blind trial unblinded clinical data can be reviewed can be reviewed by a data monitoring committee comprising experts who are usually independent of the trial management.

The main duty of the committee is to monitor the safety aspects of the trial. Aspects such as suspected adverse events and mortality are monitored. Recommendations are made to the trial steering committee and the sponsor on whether the trial can be continued or needs to be stopped early depending on any safety issues.

Central Monitoring of CRO Medical Trials

Over and above trial oversight committees, the trial can also be centrally monitored. For example, key data can be identified for review by the study team at pre -determined time points. This can be of immense benefit in the medical monitoring plan for clinical trials.

Eligibility criteria for participants may be reviewed on a monthly basis or more frequently by the trial management group. Specifics such as consent forms are reviewed to ensure the forms have been accurately completed in a timely manner.

Drug accountability logs may also be reviewed to ensure sufficient availability of stock at the testing site as well as monitoring of the dosage.

At specific time points, information which relates to a primary endpoint could also be reviewed and presented in weekly or monthly reports. This could be data about recruitment rates and patient withdrawals which could be investigated.

Safety reports submitted at specific time points and statistical analyses can be used to identify unusual data patterns or detect deviations from protocol.

One of the factors which need to be considered during central monitoring is a reliable Internet connection for uploading the trial data.

Depending on the method of data collection, and whether or not data are uploaded to a central database in real time, provision may need to be made for poor Internet connections and/or occasional power outages.

Central monitoring could also extend to statistical algorithms which have been developed to identify unusual data patterns within a trial database and review data at the site or participant level. This could help in determining systemic data errors as well as falsified data. Examples include missing or invalid data, range checks for identifying abnormal values and unusual data patterns.

In the case of trials where it is not feasible to conduct regular site visits because the sites could be scattered in different parts of the globe, statistical monitoring helps pinpoint areas which require to be focused on.

Minimising errors right from the start can help in reducing the number of monitoring visits required on site. Minimisation of errors requires careful training of data collectors working in the centralised monitoring team.

On‐Site Monitoring of CRO Medical Trials

On‐site monitoring can consist of periodic visits to the site by designated monitor. This can be a trial manager or independent contracted monitors depending on the kind of trial. Local site monitors may also be contracted, as they are most likely to be fluent in the local language as well as with cultural practices.

Early‐phase trials carry an inherently higher risk and every data point and it’s important to ensure every data point is accurate and verifiable against the source data.

In later‐phase trials, or in trials which entail less risk, important data may be verified at the site for a certain number of participants. The visits can be divided into initiation visits which take place during recruitment of patients, interim visits and a close‐out visit. Every visit should be followed by a detailed report presenting the findings. These findings can then be used to prepare a medical monitoring plan for clinical trials

Risk‐adapted Monitoring of CRO Medical Trials

The number and complexity of clinical trials worldwide has risen considerably in the past decade, prompting a shift from a traditional on-site monitoring model one that is adapted to risk. This makes it even more important to develop a robust medical monitoring plan for clinical trials.

To determine the nature and extent of clinical trial monitoring aspects such as the purpose, objective, design, size and endpoints should be considered. Risk-adapted monitoring allows a higher level of flexibility, less expensive and more targeted approach.

The Food & Drug Administration and The European Medicines Agency published reports on the benefits of risk-adapted monitoring, describing it as a systematic approach which gives priority to monitoring procedures depending on the risk level, setting risk-based priorities and identification of risk-mitigation measures.

This reduces the time and cost involved in monitoring, while ensuring the collection of high-quality data and patient safety. Both these factors are important in creating a medical monitoring plan for clinical trials.