A Comprehensive Review of Innovative Clinical Trial Strategies

Author: Anwesha Bhattacharya and Ritobrata Chandra

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Abstract

The federal government emphasizes clinical trials in evidence-based medicine and healthcare reform for improved patient care and quality. However, these trials can pose risks and produce inaccurate information. A well-designed trial requires ethical oversight. Phases I involve safety and general effects studies in volunteers Phase II evaluates the drug in a small group of selected patients. Phase III expands the study to hundreds of patients, and doctors provide feedback on adverse drug reactions (ADR) and effectiveness in phase IV. Clinical trials are increasingly under pressure to enroll patients rapidly and effectively, sometimes with very few resources. Safety data from meta-analyses is challenging to assess and interpret due to the lack of access to individual participant data, the varied nature of safety data, and the statistical difficulties of studying rare incidents. Clinical trial administration practices have evolved, with more adaptable designs emerging. These designs allow for multiple sub studies with different objectives, interventions, and subgroups within a larger master protocol structure. This study reviews existing master protocol studies such as umbrella trials, basket trials, platform trials and statistical methods like Bayesian analysis. Bayesian statistics provides a formal framework for combining information at all stages of clinical trial administration, including design, execution, and analysis. Clinical studies use biostatistics techniques to account for patient response to therapy and draw accurate conclusions, preventing fraud and inadvertent mistakes. Adaptive trial designs offer flexibility and effectiveness, but concerns about quality, validity, and trial integrity persist. However, adaptable clinical designs are increasingly discussed due to their ability to identify potential therapeutic benefits and reduce clinical development length. Adopting adaptive trial designs is expected to enhance clinical development success.

Keywords

Pre-clinical trials, Clinical trials, Traditional clinical trials, Adaptive clinical trials, randomized clinical trials, Master protocols, Bayesian analysis

Conclusion

Human volunteers participate in clinical trials to verify the new drug's beneficial qualities. Investigational novel drugs through clinical stages I, II, III, and IV following preclinical development. These phases include a thorough discussion of pharmacokinetics, pharmacodynamic profile, side effects that may be detrimental or advantageous, adverse impact, and post-marketing surveillance. But traditional clinical trials have several drawbacks. They are slower, more expensive, and less efficient compared to alternative approaches. These trials create time and financial barriers for patients who wish to participate, making it difficult for some individuals to join. Additionally, traditional trials tend to limit overall participation and take a longer time to enroll and complete. Trials with an adaptive design are frequently more effective, instructive, and moral than trials with a typical fixed design because they frequently make better use of resources, such as money and time, and may even need fewer participants. Adaptive clinical trials, such as master protocols (umbrella, platform, and basket trials), offer greater flexibility, efficiency, and cost-effectiveness in drug development. Utilizing statistical methods like randomized clinical trials ensures rigorous evaluation of treatments, enhancing the reliability and validity of clinical trial outcomes for improved patient care and medical advancements.

References

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How to cite this article

Anwesha Bhattacharya and Ritobrata Chandra (2023). A Comprehensive Review of Innovative Clinical Trial Strategies. Biological Forum – An International Journal, 15(5a): 377-387.