抄録
Translational research is becoming increasingly important at our hospital. Research must be carried out while maintaining the highest ethical and scientific standards and, in addition, it must always be medically justified. We think that the translational research coordinator (TRC) therefore has an important role to play in such clinical trials. Consequently, the management system for translational research should involve pharmacists, nurses, certified clinical psychologists and nutritionists, as TRCs in order to correctly carry out any translational research. In this paper, we describe : 1) the role of TRCs in translational research, 2) the management system governing translational research from its approval to completion and 3) the practical aspects of the TRC.
We allocate the role of doctors and each TRC in the research as follows : Doctor : draws up a protocol, carries our laboratory tests and any research based on the protocol, obtains complete information from each TRC to perform the research without any complaints from patients acting as volunteers. Pharmacist : manages data, explains the details of the protocol to the patient beforehand, visits patients, conducts drug consultations, detects at an early stage any adverse reactions and alerts doctors to such events, and performs a pharmacokinetic analysis. Nurse : manages data, explains the details of the protocol to the patient beforehand, makes out a care plan, performs patient care, and is aware of the patient's state of mind (in conjunction with a certified clinical psychologists). Certified clinical psychologist : Interviews patients before starting the research and gives instructions about correspondence between patients and doctors and TRCs, and investigates the patient's state of mind. Nutritionist : obtains information about the patient's appetite and discovers his/her dietary preferences before starting the research. All TRCs are responsible for ensuring that the medical ethical aspects of the study are complied with.
Essential documents have to be prepared regarding the management and evaluation of the study including obtaining the patient's informed consent, making up a schedule based on the protocol, devising a care plan and reporting on any adverse reactions, and keeping a patient study diary. In addition, the importance of the clinical research meeting to allow discussions about such matters as the registration of patients and the clinical courses is also discussed.
