Objectives	To translate a scientific concept into a well-designed clinical trial
Awareness	Appreciation of the scientific background of preclinical research and its limitations Appreciation of the differences in types of clinical trials (phase I, II, III and IV) Appreciation of the conceptual basis of basket trials and umbrella trials Awareness of trials through inhouse studies or (inter)national cooperative groups Awareness of the existence of an ethical committee or institutional review board to review clinical studies
Knowledge	Familiarity with the most appropriate choice of clinical trial for a clinical research question Familiarity with various statistical designs and methodologies Familiarity with the legal, ethical and regulatory aspects to conduct a clinical trial Familiarity with selecting appropriate end points of the study Familiarity with criteria for response to treatment, assessment of quality of life and their limitations Familiarity with reporting toxicity and attributing toxicity to the study interventions Familiarity with the incorporation of biomarkers (including, but not limited to, DNA sequencing) in clinical studies and their opportunities and limitations Familiarity with correct interpretation of clinical data Familiarity with grant writing, and writing and presenting a study report to communicate the study outcome to the community Familiarity with preparing informative material for patients and asking informed consent Familiarity with the responsibilities of a clinical trial steering committee or an independent data safety monitoring committee Understanding of the bioinformatics of DNA sequencing and the ethical issues surrounding germ line sequencing
Skills	Ability to contribute actively to a variety of phase I/II clinical trial scenarios and patient presentations Ability to contribute actively to scientific discussions between preclinical and clinical scientists Ability to discuss critically the optimal design of a clinical study Ability to select primary, secondary, tertiary and exploratory end points of a study Ability to determine therapy according to molecular marker status Ability to appreciate considerations in the management of a phase I study depending on the side effects and treatment outcomes Ability to prepare an amendment to a clinical trial Ability to follow Good Clinical Practice (GCP) rules Ability to critically evaluate publications on clinical trials Ability to present a study report to communicate the study outcome to the community Ability to critically evaluate clinical trial data and to apply them to individual patient decision-making and to use this information to obtain informed consent