An Integrative Review of Multistage Clinical Trials

Introduction: Clinical trials have long been vital to advancing how to prevent, diagnose, and treat diseases. However, traditional clinical trials are limited to one-stage interventions and therefore have little flexibility. With application of precise medicine, new concepts in terms of design can increase the flexibility of clinical trials, which in turn augment the likelihood that a trial will benefit the most people who participate. Materials and Methods: In today s world, we are facing the spread of various diseases. Thus, physicians have to make numerous treatment decisions in different stages of the disease. In practice, such decisions represent the way physicians treat patients, but this is statistically a dynamic treatment regimen (DTR). Effective DTRs can be developed and studied in clinical trials called Sequential Multiple Assignment Randomized Trials (SMART). Results: A total of 30 studies were extracted from reliable databases and websites, and research related to SMART was reviewed. Conclusion: Considering that most experiments are performed in one step, and intermediate events are ignored and that focus is on the final event, introducing SMART plans and the concept of DTRs is important for researchers and clinical colleagues; treatment guidelines must encompass entire treatment regimens in order for them to be useful for clinicians and patients.