In a traditional clinical trial, the treatment is designed, conducted and then the data is analyzed according to the prescribed plan, leaving no scope for any modification in the design.
Adaptive trial designs provide an alternative. It permits alterations to a clinical study with respect to gathering data to make trials more flexible, efficient, and also ethical. It allows reducing the risk of failure by factoring in analyses at key points so study design parameters like dosage, sample size, or patient selection can be adjusted accordingly.
Why the Move to Increased Flexibility?
With an event of rare diseases and emergency breakouts of pandemics, the time associated with traditional trial methods is not only infeasible but can even be unethical in delaying the provision of treatment. Hence, flexibility and adaptive features of clinical designs are vital.
Adaptive Trial Designs can help in carefully evaluating clinical data in real-time, so you make informed decisions to change the course of the study for a better chance of success. A well-designed and executed Adaptive Design can:
- Maximize the trial information
- Shorten development timelines
- Reduce overall development expenses
- Lessen the risk for study volunteers and sponsors
- Increase the probability of success for the new therapy
Adaptive Trial Design Is Better for Patients
Multiple treatment arms can be included under one design in the adaptive clinical trial design. Patients can be shifted between these arms if a particular treatment type is not working for them, resulting in shorter trials and quicker routes to market for trial drugs.
Potentially important consequences of adaptive trial design are that the target group could shift, or the clinical study questions asked at the beginning could change. It is a smarter way of conducting a trial as it helps patients get the drugs that are best suited and can be switched to an alternative treatment arm more quickly when there are indications that a drug is not working for them.
Software to Support Flexibility
To achieve adaptivity -maximizing the use of trial protocols requires better collaboration between the study stakeholders and a comprehensive Clinical Trial Platform to manage and enhance adaptable designs. A flexible configurable system should be able to quickly adapt to the changes in the study design on the fly without system downtime.
It is important that the chosen platform adheres to the trial protocols, provides robust and accurate data capture management, includes adverse event coding, statistical consultation, and generates real-time reports.
For example, the Clinical Trial Platform should be able to accommodate the addition of multiple sites on the go, run multiple study versions simultaneously of the same Study, it must support the release of protocol amendments to individual sites in a targeted manner based on their respective Institutional Review Board (IRB) Approvals, ensuring system availability to the other sites with no system downtime.
SyMetric addresses all of these and much more. SyMetric Clinical Trial Platform makes technical requirements easier to manage and provides more solutions to trial managers. Our Cloud-based, Integrated IRT/WRS, EDC, Medical Coding, and CTMS functionality are all included in a single database to make operations more flexible, efficient, and adapt to evolving needs of the study, providing flexibility in go-live timelines. It is designed to support you with protocol management, CRF design, metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities that help you monitor, and manage trials effectively, every step of the way.
Whether you are a Clinical Research Organization, Pharmaceutical Company, or Academic Institution, our Platform can be tailored to your study requirements, including Adaptive Trials, Umbrella Trials, Basket Studies, and Virtual Clinical Trials. You can integrate your processes with our user-friendly applications or choose from comprehensive modules for every stage of your trial.