Clinical trials have certainly evolved in the past decade. Modern technology such as EDC systems has wholly transformed the clinical research landscape. Companies such as ClinicalPURSUIT are working hard to provide researchers, CROs, and sponsors with high-end systems and software that aid them in their trials. An important recent development pertains to the area of adaptive clinical trials. Adaptive clinical trials are also another innovation that provides added flexibility to some study aspects. These options are being actively explored in medical device development, and the findings are being applied to drug development. Let’s have an in-depth look into the world of adaptive clinical trials and their advantages.
Adaptive Clinical Trial Design Advantages
Adaptive clinical trial design can streamline clinical trials by reducing the number of patients and trials. Adaptive design can result in more informative and result-oriented trials. Clinical safety is also ensured when using adaptive clinical design. When conducting early-phase studies and exploratory trials, you can consider using adaptive designs.
You can test a variety of specimens, regimens, populations, and doses which gives you added flexibility when you want to make impactful decisions. It also helps to expose fewer subjects to treatments while getting optimal results. Adaptive clinical trial designs are the future of clinical research and will assist researchers in carrying out more effective trials.
When considering adaptive designs for your trials, you need to carefully choose the aspects that can be modified as not all of them can be changed. Wrong choices or unnecessary flexibility may introduce bias in a trial which can be detrimental to the efficacy of the whole process.
Conducting a thorough analysis of your study and its need and requirements will put you in good stead to introduce modifications in your trial. You can consider adaptations to randomization procedures or changes to the sample size based on preliminary results. These are a few examples you can consider when modifying certain aspects of your clinical trials.
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You need to choose your adaptive design very carefully, and the 2019 FDA guidelines identify four critical areas to consider during the design process. One controls the chance of erroneous conclusions, the second estimates treatment effects, the third is trial planning, and the fourth is maintaining trial conduct and integrity.
Adaptive clinical trial designs offer many advantages over conventional counterparts and promise to be bigger, better, and more efficient. However, there is always a risk factor involved. To make the whole process more efficient, you need to carefully integrate adaptive designs with modern technology such as EDC systems for clinical trials.
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If you operate a clinical trial setting and are on the lookout for quality, robust, and effective Clinical Trial Data Management Solution and Clinical Trial Data Management Software, check out the products and services offered by ClinicalPURSUIT. We are pioneers in providing quality CTMS solutions that’ll help you automate the processes, provide real-time reports, and help you collaborate with your peers.
We also offer various other services such as Randomization and Drug Supply Management, Electronic Patient-Reported Outcome Software, etc. You can visit our website for more information or schedule a one-on-one free demo today!