Abstract
This introductory chapter discusses the phases of clinical trial design and innovative platforms, such as STAMPEDE and KEYNOTE-001, which have more efficiently guided treatments toward regulatory approval. A study by Booth et al. that reviewed randomized clinical trials in breast, non-small cell lung, and colorectal cancer to evaluate trends in methodology and reporting, funding, and the interpretation of outcomes is discussed. The Consolidated Standards of Reporting Trials (CONSORT) guidelines which have been developed to standardize and improve the quality of reporting of clinical trials are discussed.
This book summarizes key findings from approximately 250 landmark clinical trials in oncology. The author makes no claims toward completeness. Rather, the selected studies served to inform the author, a radiation oncologist practicing in the community. The material is for educational purposes only, serving as a starting point for deeper and more nuanced inquiry.
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Bibliography
James ND, et al. for the STAMPEDE Investigators. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377:338–51.
Kang SP, et al. Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic. Ann Oncol. 2017;28(6):1388–98.
Booth C, et al. Evolution of the randomized controlled trial in oncology over three decades. J Clin Oncol. 2008;26:5458–64.
Kenneth Schulz et al for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Lancet. 2010.
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Yajnik, S. (2019). Introduction to Landmark Trials in Oncology. In: Landmark Trials in Oncology. Springer, Cham. https://doi.org/10.1007/978-3-030-14405-0_1
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DOI: https://doi.org/10.1007/978-3-030-14405-0_1
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