Innovation and strategy in clinical research with the SCIOSM method
BBCR Inc. Natick, MA USA.
Review
Open Access Research Journal of Science and Technology, 2023, 09(01), 030–036.
Article DOI: 10.53022/oarjst.2023.9.1.0053
Publication history:
Received on 28 June 2023; revised on 27 August 2023; accepted on 29 August 2023
Abstract:
Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Healthcare has been changing rapidly for many years. The COVID-19 pandemic has accelerated by helping drive the shift to value-based healthcare. Instead, the productivity of pharmaceutical development has been declining due to high failure rates in clinical research. The SCIO method is an innovative and strategic method implementing a tailored approach to drug development. The SCIO method customizes strategy and roadmap for pharmaceutical and biological candidates allowing robust clinical data generation and informed decision-making during the early clinical development stages.
The complexity of diseases contributes to the high failure rate and increases the cost of research. Clinical research in developing new drugs and treatments is associated with a high late failure rate. Late-stage trial failures can delay patients' access to potentially lifesaving or disease-modifying treatments.
Strategy is valuable in reducing late clinical trial failure. A well-developed and carefully executed strategy helps mitigate risks, optimize trial design and execution, and increase the chances of successful outcomes. A failed trial can harm the credibility by raising concerns about the research methods, the quality of the data, or the reliability of the therapy under investigation.
The SCIO is an innovative drug development method, including a strategic approach before initiating clinical trials that ensure a solid scientific basis and a reasonable likelihood of success in human trials.
Keywords:
Early Clinical Studies; Drug Development Strategy; Regulatory Strategy; Translational Medicine; Clinical Plan Innovation; Clinical Trial; Clinical Research Organization; Strategy Clinical Plan; Clinical Research
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0