Randomization in clinical trials is a core component of any clinical trial that is seeking marketing authorization by the FDA. As you may know, the world of clinical trials is heavily regulated and controlled by relevant government bodies. Clinicians, CROs, sponsors, and others involved in modern medical research must adhere to several rules and regulations that ensure medical research’s safety, security, and reliability and the subsequent therapeutic development. A core component of a robust clinical EDC system is
Clinicians are actively searching for technologies such as EDC systems for clinical trials to help them follow the rules and regulations and ensure that the entire process is foolproof. One of the major aspects important for the impartialness and unbiasedness of studies is applying randomization in clinical trials.
This ensures that all data captured through EDC systems and subsequent analyses are conducted fairly. Let’s look at some of the dos and don’ts of using randomization in modern medicinal research.
Do Use an IRT System
One of the first things you’d need to do is to implement an interactive response technology system that ensures blinding and prevents bias in a clinical trial. While other methods such as manual randomization and blinding via envelopes can do the job, using IRT ensures that you minimize every chance of bias in clinical research. These systems eliminate human errors that can be detrimental to the health of the trial and offer various advantages compared to other conventional methods.
Do Maintain Audit Trails
You also need to maintain audit trails to ensure regulatory compliance. An effective IRT system such as the one supplied by ClinicalPURSUIT ensures all your data trails are tracked electronically and also provides a comprehensive report on every randomization that has occurred in the data collection process. IRT system also provides clinicians a greater hold of the data as they can control who can access critical data that must be kept in a safe and secure environment.
Don’t Have Many Stratifications Factors
Having various stratification factors will increase the risk of partiality and treatment imbalance. It also increases the risk of having insufficient subjects in each stratification level, which provides a roadblock to determining statistical significance.
Randomization is key to conducting efficient clinical trials, and you need to implement the best measures to ensure the impartialness and reliability of your medical research. Having said that, you should look to invest in a robust IRT system that helps you achieve your clinical goals.
Get Started with ClinicalPURSUIT
If you’re looking for efficient IRT systems and state-of-the-art EDC systems to help you in your clinical trials, check out the products and services provided by ClinicalPURSUIT. We have provided clinicians, CROs, sponsors, pharmaceutical companies, and others involved in modern medical research and development with state-of-the-art clinical trial data management solutions that help them conduct efficient clinical trials.
We are HIPAA compliant, and our products and services offer the latest technology that is helping those involved with clinical research and trials with effective data collection and analyses.
We also provide products and services such as Randomization and Drug Supply Management, Electronic Patient-Reported Outcome Software, Clinical Electronic Data Capture Software, and more. Schedule a one-on-one free demo today to check out our products.