Publications by authors named "N Morakote"
Background/aims: An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials.
Methods: This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020.
Article Synopsis
- - The study explored what information child participants and their parents consider important in informed assent/consent forms for pediatric drug trials, using a survey rating system from 1 (not important) to 5 (very important).
- - A total of 22 families participated, highlighting critical elements like direct health benefits, societal benefits, major risks, and adverse effects, which received high importance ratings from both children and parents.
- - The findings suggest that risk-benefit information should be prominently featured in informed assent/consent forms to better meet the needs of pediatric participants and their guardians in clinical trials.
Background: In 2014, the Thai government launched a free-of-charge long-acting reversible contraception (LARC) program for Thai female adolescents. However, its acceptance had not been reported. Therefore, this study aimed to describe contraceptive use among women of reproductive age before and after the program was implemented.
View Article and Find Full Text PDFScientific validity and risk assessment are two main ethical issues which raise specific challenges and are unique to clinical trials investigating crude extracts/fractions from herbal materials. There are considerable challenges for both clinical investigators and ethics committee members in dealing with such issues, many of them remain unresolved, resulting in a large variation in ethical requirements, justification, and decisions. Despite a remarkable surge in herbal medicine research globally, a number of clinical investigators or even ethics committee members have limited confidence in dealing with related ethical issues.
View Article and Find Full Text PDFUnlabelled: Genitourinary syndrome of menopause (GSM) is common among postmenopausal women, but, in general, not all of the patients seek medical advice as this sensitive issue can cause them embarrassment.
Objectives: To explore the prevalence of GSM among Thai postmenopausal women and their disclosure of and attitude towards GSM.
Methods: A questionnaire was used to obtain information on GSM from 499 Thai postmenopausal women who attended the Menopause Clinic at Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand, from November 2015 to August 2016.