Cancer: Clinical Trial Design and Principles

Cancer: Clinical Trial Design and Principles

Rashi Rai, Prudhvilal Bhukya, Muneesh Kumar Barman, Meenakshi Singh, Kailash Chand, Subash C. Sonkar, Manjita Srivastava
Copyright: © 2021 |Pages: 12
DOI: 10.4018/978-1-7998-6530-8.ch024
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Abstract

Clinical trials are essential to govern the impact of a new possible treatment. It is utilized to determine the safety level and efficacy of a certain treatment. Clinical trial studies in cancer have provided successful treatment leading to longer survival span in the patients. The design of clinical trials for cancer has been done to find new ways to prevent, diagnose, treat, and manage symptoms of the disease. This chapter will provide detailed information on different aspects of clinical trials in cancer research. Protocols outlining the design and method to conduct a clinical trial in each phase will be discussed. The process and the conditions applied in each phase (I, II, and III) will be described precisely. The design of trials done in every aspect such as prevention, immunochemotherapy, diagnosis, and treatment to combat cancer will be illustrated. Also, recent innovations in clinical design strategies and principles behind it as well as the use of recent advances in artificial intelligence in reshaping key steps of clinical trial design to increase trial success rates.
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Types Of Oncology Clinical Trial

Prevention

The prevention trials focus on ways of preventing cancer or recurrence. For example, the trial focusing on the use of vitamins, change in diet, the use of different medications or exercise for decreasing the chances of developing cancer. A related study was done considering a hypothesis that if the intake of dietary fat is reduced, the incidence of breast cancer will also reduce. It was found that total dietary fiber was associated with lower breast cancer risk in the early adulthood of women (Maryam S.F. et al., 2016). Also, some of the FDA-approved approaches include; the risk of breast cancer by using raloxifene or tamoxifen and cervical cancer prevention using vaccines generated against papillomavirus.

Screening

In cancer, one of the biggest problems is to detect the disease at an early stage and lack of which makes it one of the deadliest diseases. The screening trials focus on detecting and identifying cancer in people who are not suffering from cancer. The screening trial includes three types of tests such as; imaging test-which produces pictures of areas inside the body, laboratory test- which checks urine, blood and other body fluids and tissues and genetic tests- which checks for inherited genetic markers which are linked to cancer (Black W. C., 2006).

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