Analysis of the status of subject recruitment in clinical trials in Shandong, China.

Although subject recruitment for clinical trials in Shandong has been carried out with an awareness of international regulatory and ethical frameworks, there have been some defects in the recruitment process. The objective of this study is to analyze the current status of subject recruitment in Shandong. We conducted a survey among 198 principal investigators (PIs) and 543 subjects. The results were summarized and calculated as a percentage according to the responses to each question by PIs and subjects. This survey indicated that the ethics committee should strengthen the review of subject recruitment and enhance ethics training among board members. PIs should seek to improve the recruitment process.