Investigator Responsibilities in Clinical Research

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Investigator Responsibilities in Clinical Research,Topics to be Discussed,Overview of Clinical Trials,Good Clinical Practice,The“Research Team”,The Role and Responsibilities of the Principal Investigator,Overview of Clinical Trials,Definition,Research studies involving patients or populations at risk for disease,May be directed at questions of causation,prevention,early detection or treatment,Designed in a scientific manner and conform to ethical standards,Importance of Clinical Trials,To increase knowledge,To provide“evidence-based”patient care or prevention of disease,To improve the quality of care,Patients participating in a trial tend to receive better care,Quality of care for other patients who are not participating in a trial can also be improved(i.e.,supportive care),Why the Emphasis on Evidence?,To reverse the following problems:,Assumptions that are not based upon facts continue to be made,Doctors work largely independently without incentives to update their knowledge often“behind the times”,Traditional or professors approaches generally used may be ineffective,“Eminence based”medicine,Who Conducts Clinical Trials?,Academic centers,Groups of academic centers cooperative groups,Government agencies or institutions,Corporations(pharmaceutical companies,biotechnology companies),Usually done via academic or private institutions,The Conduct of Clinical Trials,Frame a hypothesis based upon present knowledge,Is the study question important and relevant?,Design a study to test the hypothesis,Write a detailed plan of the study(protocol),Obtain ethical review and approval,Conduct study,adhering closely to the protocol,Collect relevant,pre-determined data elements,Ensure that the data is of the highest quality possible,Analyze the data and draw conclusions,The Protocol Document,Detailed plan and instructions for the conduct of the trial,Guidebook for those involved in the day-to-day care of the patient enrolled on the trial,Elements of the Protocol Document,Title Page,Objectives(primary and secondary),Background and rationale,Eligibility Criteria(inclusion and exclusion criteria),Evaluation parameters baseline and those that support and confirm eligibility,Treatment plan,Modifications,Supportive care,Concurrent therapies(including contraindications),Elements of the Protocol Document,Treatment Plan(cont),Surgical guidelines,Radiation therapy guidelines,Off-study criteria,Post-study evaluation(what tests should be done and how often),Data collection and reporting procedures,Statistical section,Sample size,study duration,relevant endpoints,Elements of the Protocol Document,Statistical section,How endpoints will be evaluated(e.g.,response,adverse events),Multi-institutional guidelines(if applicable),Elements of the Protocol Document,Ethical Considerations,Discussion of rationale for risks,Are risks reasonable in relation to the anticipated benefits?,Are risks reasonable in relation to the importance of the knowledge to be gained?,Elements of the Protocol Document,Ethical Considerations(cont),Informed consent procedures,Conflicts of interest,Pharmaceutical Section,Information about the study drug(s),Publication Policy,Who will be involved,registration of the trial,References,Good Clinical Practice(GCP),International and scientific,quality standard,for:,Designing,Conducting,Recording,Reporting,Trials that involve the participation of human subjects,Compliance with GCP,Provides,public assurance,that the:,Rights,safety and well-being are protected and consistent with the Declaration of Helsinki,Ensures that,clinical trial data,and,reported results,are:,Accurate,Credible,Do We Really Need GCP?,Why We Need GCP,International concern for the protection of human subjects involved in research has increased,Historical influences(WWII,vulnerable populations),Need for research to advance medical knowledge,Unified to facilitate mutual acceptance of clinical data by regulatory authorities,The Research Team,Definition,A group of people working together in a systematic and scientific manner to establish facts,Committed to applying the principles of GCP in the conduct of clinical research that may have an impact on the,Safety and well-being of human subjects,Members of the Research Team,Principal Investigator,Co-investigators or associate investigators,Clinical research coordinator,Data manager,Clinical pharmacist,Statistician,Members of the Research Team,Patient(s),Institutional Review Board(IRB),Regulatory Bodies,The Principal Investigator,The individual who actually conducts the clinical trial or research study(usually referred to as the PI),The leader of the research team at the site,Qualifications of the PI,An appropriately qualified person in the relevant field of health care(MD,PhD,Pharm D,nurse),Trained and experienced in clinical research,Familiar with the study background and requirements,Responsibilities