Objective: To investigate the guardians’ experiences and cognition of involvement in pediatric drug clinical trials

so as to provide reference for promoting the development of pediatric drug clinical trials. Methods: Guardians of children hospitalized in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Children’s Hospital of Fudan University

Children’s Hospital of Shanghai Jiaotong University and Harbin Children’s Hospital from Jan. to Aug. 2017 were extracted for the questionnaire survey. Results: Totally 468 valid questionnaires were returned

and only 4.9% of the guardians had experience of involvement in pediatric drug clinical trials. And 6.4% of guardians had the willingness to participate in pediatric drug clinical trials

primary school-educated guardians had no willingness to participate

and 52.1% of the guardians depended on the situation

the influence of educational factors on guardians’ willingness was statistically significant (P<0.01). The primary reason for guardians’ willingness to participate in pediatric drug clinical trials was disease necessity. And 73.1% of guardians considered that children need to understand and sign the informed consent. And 57.7% of guardians considered that children aged 12 years and above were able to understand the content of the informed consent and could sign it. Conclusion: Most guardians had no experience of involvement in pediatric drug clinical trials

and there are differences in the degree of cognition of content of pediatric drug clinical trials and the understanding of informed consent among guardians with different education levels. The improvement of social cognition of pediatric drug clinical trials is the important factor to ensure the positive development of pediatric drug clinical trials.