Ethical Challenges in Conducting Clinical Trials for New ChemicalEntities

Abstract

Over the past three decades the quest for the testing of new chemical entities for emerging and old diseases without therapeutic drugs has increased. The uses of randomized controlled trials (RCTs) have become more popular over clinical judgment, case reports, and observational studies and became the gold evidential standard in medicine. In addition, RCTs has become the main component of the regulatory process whereby a new therapeutic can gain access to the drug market. Currently, clinical trials for new drugs are large and a tightly regulated enterprises that have to comply with ethical requirements while maintaining high regulatory standards, a balance that becomes increasingly challenging as the research questions become more sophisticated. In this chapter, some of the most important ethical issues involving RCTs, with emphasis on the most recent debates and the context of oncological research in particular have been discussed.