History of sequential screening1/17/2024 ![]() Consequently, the patient’s survival depends not only on the frontline treatment but also on the entire treatment strategy. In oncology, as in many other chronic conditions, it is common that the patient receives a frontline treatment followed by subsequent treatments adaptively chosen by the clinician. The main difficulty in implementing trials to study DTRs is that there are still several open questions about sample size calculation and identification of the most appropriate method for data analysis. They are of growing interest in the scientific community, but their use is not well-established yet. SMART designs randomise patients at each decision point considering information collected on the patient so far. The types of study commonly used for testing and comparing DTRs include observational studies, one-time randomised trials that randomise patients only once to the whole DTR, and sequential multiple assignment randomized trials (SMARTs). ![]() However, providing evidence-based DTRs poses relevant methodological challenges to study design and DTRs’ effect estimation. Cancer is a chronic disease that requires treatment at multiple stages, according to each patient’s characteristics and clinical status. Particularly, cancer research is a promising field of application of SMART designs. In this sense, identifying the optimal DTR would be a way to put evidence-based precision medicine into practice, especially in chronic disease management, which is one of the most suitable clinical settings for DTRs. The final aim of the decision process is to tailor the treatment to the patients’ characteristics and clinical history, which is the key concept of precision medicine. The DTR represents a formalisation of the multi-stage and dynamic decision process followed by clinicians in their everyday clinical practice. Each rule establishes the treatment for the patient among the available treatment options according to the information collected until then. Formal reporting guidelines for SMART designs are needed.ĭynamic Treatment Regimens (DTRs), also known as adaptive treatment strategies or adaptive interventions, are a set of sequential decision rules, each one corresponding to a key decision point in the patient’s history. Study powering and analysis is mainly based on statistical approaches traditionally used in single-stage parallel trial designs. SMART designs in oncology are still limited. Furthermore, most of the records considered each stage separately in the analysis, without considering treatment regimens embedded in the trial. Conversely, 13 of 18 study protocols and trial registrations defined the study design SMART. ![]() ![]() The study design was defined as SMART by only one out of fifteen trial reports. Fifteen were reports of trials’ results, four were trials’ protocols and fourteen were trials’ registrations. After title/abstract and full-text screening, 33 records were included. A systematic review was conducted, searching PubMed, Embase and CENTRAL for protocols or reports of results of SMART designs and registrations of SMART designs in clinical trial registries applied to solid tumour research. The present work investigates the state-of-the-art of SMART designs in oncology, focusing on the discrepancy between the available methodological approaches in the statistical literature and the procedures applied within cancer clinical trials. Sequential multiple assignments randomized trials (SMARTs) are a type of experimental design where patients may be randomised multiple times according to pre-specified decision rules.
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