A questionnaire survey was taken on the subjects administered an investigational new drug in order to look into their attitude toward a clinical testing and assessment of the work of the pharmacists clinical research coordinating the testing. Questionnaires were sent to 75 outpatients who were tested on with a new drug between January 2001 and March 2006. 55 individuals responded to the inquiry. All the subjects were taken care of by the coordinators by turns. The major concerns to the testees when they participated in the trial were the adverse reactions and efficacy of the new drug. Of the subjects who felt uneasy, 79.4% cited the adverse reactions and 50% about the efficacy. Some 80% of the respondents said they were satisfied with the explanation given beforehand about the nature of the clinical testing. The majority of the subjects, when they were in a fix, turned to pharmacist clinical reave coordinators for advice, not the physician nor nurses. The guidance given by the clinical reave coordinators about medication was generally received favorably. From the above-mentioned findings, it was made clear that the pharmacists clinical research coordinating the clinical trial played an important role as consultants in alleviating the anxiety of the testees during the trial. In the future, pharmacists will do the best to measure up to the expectations as coordinators in the clinical trial of new drugs by improving care of the testees individually while taking into their backgrounds and wishes into full consideration.
Clinical ; Questionnaires ; Clinical Trials ; Clinical Research ; Testing

Clinical Trials as Topic ; Dentistry ; Humans

Controlled Clinical Trials as Topic ; Humans ; Randomized Controlled Trials as Topic

Clinical Trials as Topic ; Hepatitis B, Chronic ; Humans

OBJECTIVEIn order to provide readers with general concepts and methodology on adaptive designs for clinical trial.

METHODSDefinition of adaptive designs for clinical trial and basic idea of adaptive adjustment were introduced through an example.

RESULTSThe relationship between adaptive designs and group sequential design was summarized. Ways to embody two basic statistical rules of clinical trial under adaptive adjustments setting were also introduced.

CONCLUSIONAdaptive designs provided clinical trial with a great flexibility, which could greatly improve the efficiency of clinical trial.

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
Clinical Trials as Topic ; Databases, Factual ; Documentation ; standards

Clinical Trials as Topic ; Humans ; Leukemia ; drug therapy

Clinical Trials as Topic ; standards ; Humans ; Quality Control

Clinical Trials as Topic ; Dentistry ; Humans ; United States

In this paper, we analyse the general information of medical equipment clinical trials by clinical trial process management experience to elaborate the characteristics of the medical equipment clinical trials and the existent problems in our hospital in 10 years. We propose corresponding countermeasures to ensure the quality of medical tests, and improve the management of medical equipment clinical trials in hospital.
Clinical Trials as Topic ; Equipment and Supplies, Hospital ; Humans