Pediatric Oncology Surgery: Research Methodology

Improvements in outcome of children with cancer have resulted from sequential clinical research studies to answer therapeutic questions and implement results. Clinical trials methodology is broadly divided into observational and interventional studies, where the observational methodology utilized natural differences between study groups or their management to answer research questions, while interventional trials study outcomes of actively instituted therapeutic change. Both types of clinical research have stringent methodological requirements and objective limitations, necessitating their understanding before initiation. Additionally, since clinical research is conducted on human subjects, strict regulations are enacted to ensure their safety and ethical treatment. These regulations mandate voluntary participation and espouse the three basic principles of respect for persons (acknowledgment and protection of autonomy), beneficence (obligation to not harm; maximize benefits and reduce risks), and justice (equal treatment and just distribution of burdens and benefits). While international and local regulations exist, research conduct oversight is firstly relegated to Institutional Review Boards (IRB), also referred to as a “research ethics committee,” that review and monitor biomedical and psychosocial research with the main objective of protecting the rights and welfare of subjects. Quality improvement research involves systematic data-driven activities to bring about immediate and positive changes in healthcare delivery to optimize clinical practice in the local setting. The objectives and ethical underpinnings here are different from traditional human subject research, as are the methodologies used. All research is based on data, and the quality of the data collected impacts study outcomes. Data quality depends on the stringency of the data variables (data definitions) and their collection (case report forms) and storage (database) methodology.