Phase 3 clinical trials, lasting for over 5 years, represent a critical stage in the development of new drugs and medical treatments. They are conducted after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 trials. The primary goal of Phase 3 is to confirm the drug’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Let’s discuss in detail what is phase 3 clinical trial, covering how AQ CTMS streamlines it.
Scale and Scope
Phase 3 trials are large-scale studies, involving a larger number of participants compared to the earlier phases. Typically, these trials include several hundred to several thousand participants. The participants are usually from diverse geographic locations and often have the condition or disease that the treatment is aimed at addressing. This broad participation helps in ensuring the generalizability of the trial results.
The AQ CTMS can efficiently handle a high throughput of patients through automation, enabling streamlined data processing and adaptive protocols. Its capacity planning and appointment management features, including an e-planner, optimise resource allocation and scheduling, ensures seamless coordination in large-scale Phase 3 trials.
Study Design
The design of Phase 3 trials is often randomised and double-blind, reducing the risk of bias. AQ CTMS empowers the establishment of operational study designs, effectively preventing out-of-window deviations during the appointment booking process.
It also aids in error-free and quick protocol management, ensuring adherence to the study protocol while facilitating the distribution and implementation of any protocol amendments across sites.
Objectives and Outcomes
The primary objectives of Phase 3 clinical trials are to demonstrate the therapeutic effect of the new treatment, establish the overall benefit-risk relationship of the drug, and provide an adequate basis for physician labelling.
AQ CTMS contributes to these objectives by offering tools for accurate data collection, including electronic data capture (EDC), and integrated statistical analysis tools for interim analysis to assess efficacy and safety.
Regulatory Approval and Post-Market Surveillance
If the results of Phase 3 trials are favourable, the drug developer will use the data to file for regulatory approval, such as a New Drug Application (NDA) with the FDA.
AQ CTMS plays a crucial role in phase 3, ensuring that all necessary documentation for regulatory submission is accurate, up-to-date, and readily available. It also maintains a detailed audit trail of all actions and changes, essential for regulatory compliance. Even after approval, AQ CTMS continues to support post-market surveillance studies by managing additional data collection and analysis.
Wrapping Up
Researchers can navigate the complexities of Phase 3 clinical trials successfully by integrating a comprehensive Clinical Trial Management System like AQ CTMS is crucial. AQ CTMS streamlines participant management, data collection, protocol adherence, and regulatory compliance, enhancing efficiency and accuracy throughout the trial process.
Indeed, utilising CTMS tools for scale management, study design, data collection, and other aspects ensures that medications brought to market are safe and effective while simplifying the regulatory approval journey.
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