Abstract
ObjectiveThe changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.MethodsThis study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.ResultThe most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%.DiscussionIt has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.ConclusionThe clinical research coordinators’ access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.
Highlights
On July 22, 2015, The China Food and Drug Administration issued The Announcement of Self-examination and Inspection of Drug Clinical Trial Data [1] and annotated 1622 drug registration applications list
It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator
If the pharmaceutical company continues to apply after the selfexamination and the authenticity problem is found in the CFDA inspections, all application of this pharmaceutical company will not be accepted within 3 years
Summary
On July 22, 2015, The China Food and Drug Administration issued The Announcement of Self-examination and Inspection of Drug Clinical Trial Data [1] and annotated 1622 drug registration applications list. As a thunder, it opened what the industry called the 7.22 storm. In the bulletin of 7.22, CFDA requires all pharmaceutical companies who have submitted an applicant of drug registration and are waiting to be approved must carry out self-examination on the clinical trials in accordance with the 《Good Clinical Practice of Pharmaceutical Products》 [2] and the clinical trial protocol, so as to ensure the authenticity and reliability of clinical trial data and the integrity of relevant evidence. If a drug clinical trial medical institution practices fraud, its qualification shall be revoked
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