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