CLINICAL TRIAL ADVANCE MONITORING
Introduction:
The purpose of clinical trials is to collect relevant data to discover new drugs to cure or prev
ent diseases. Furthermore, this data assists academics, industry, and regulatory bodies in making critical decisions about the safety and effectiveness of medicines and vaccines being studied. Clinical research sponsors typically assign CROs critical project responsibilities, such as quality assurance.
As a supplier of contract research organizations, CROs help project sponsors with the development of protocols, monitoring and evaluation of completed projects, and providing documentation to regulatory authorities. It is imperative that clinical research data is good enough to be audited and inspected by regulatory agencies.
Clinical Trial Monitoring: Why It Is Important:
Due to the ever increasing regulatory compliance demands, intricacies, and costs of conducting clinical research, the scenario of clinical research studies is becoming more complicated. In order to overcome these constraints, technological optimization is necessary. The focus of organizations today is more on meeting up with rising costs and deadlines than ensuring patient safety and regulatory compliance. As a result, clinical trials have become increasingly dependent on monitoring.
According to the sponsor's requirements, a monitoring plan will be developed. Depending on the trial complexity and risk, monitors should be conducted in accordance with a schedule. A trial must have onsite monitoring in order to be adequately overseen.an onsite monitor with a central/remote monitor. The monitor must conduct and document the trial properly. In this role, a monitor acts as a liaison between a sponsor and an investigator.
Monitoring with advanced technology:
Using advance monitoring, this section aims to reduce the amount of on-site monitoring. An electronic pass-through mechanism can be used to monitor medical records by converting them into password-protected PDF files that are accessible for a limited time. We will redact some source documents into PDFs, such as informed consent forms. The full participant research charts in PDF format will not be redacted.
Scientists who work on clinical trials can, for starters, do the following:
Implement CDISC standard datasets and centralized monitoring for more efficient, real-time data collection
Analyze data in a way that is superior to that used for standard risk-based monitoring (RBM)
Identify and correct errors quickly with ongoing, sophisticated, and accurate monitoring reports
Enhancing monitoring through modernization:
A number of ways can be transformed through technology enablement in trial monitoring, including automated key risk indicator management, early detection of patient safety and eligibility signals, and auditable and traceable workflows for managing risks at the study, site, and patient levels.
In terms of modernizing monitoring incrementally, sponsors could see integration as:
The first level of RBM involves the use of risk-based strategies and centralized monitoring to reduce the amount of on-site monitoring visits required of clinical research associates (CRAs).
The second level combines RBM and decentralized trials (DCT) by utilizing integrated monitoring capabilities and the emerging DCT technology framework for remote patient and site management, saving time and focusing on the needs of patients.
The third level Using patient-generated data via remote monitoring to further transform clinical monitoring and improve direct-to-patient tools and processes.
Furthermore, AI and machine learning capabilities enable monitoring of safety trends across sites, participants, or regions to make necessary changes quickly.
Advantages of Risk based Monitoring:
Risk based monitoring and centralised monitoring will help detect problems early so that they can be resolved quickly - thereby protecting patients and ensuring the reliability of the study as a whole.
Centralised monitoring is increasingly being seen as a more effective way of detecting non-compliance and data fabrication than 100% SDV. By using electronic Case Report Forms (CRFs), all CRF data can be imported to a central File, along with operational, quality, efficacy and clinical safety data from all sites in multiple studies. Automated programs can then identify any deviations in real time, impartially and accurately. Furthermore, these programs can be used to predict potential protocol deviations due to lack of training or competency issues.
Conclusion:
Data quality is key to improving patient outcomes, and modern clinical development approaches such as centralized monitoring and risk-based monitoring (RBM) offer many benefits. These include greater visibility, automated identification of issues in real-time, the ability to proactively reduce errors or compliance issues, and detection and analysis of early signals on a subject-by-subject basis. This helps to ensure high data integrity and quality throughout the study process. Automating processes can also speed up reporting of study results - potentially reducing both the cost and time needed for treatments to reach market by up to 40%. Such solutions prove that difficult situations can lead to creative solutions that benefit everyone.
References:
Iqvia.com
Advancedclinicaltrials.com
By Jennifer Dennis-Wall, Ph.D., Mujataba Sharief, Ph.D., Hemalatha
Raju, Ph.D.
Student Name: B. Vineela
Student ID: 060/032023
Qualification: Pharm. D
e-Mail ID: vineelabodapati@gmail.com
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