Objective: To explore the establishment and roles of study nurses in IBD drug
clinical trials. Methods: The management experience of this department’s
study nurses in IBD drug clinical trials was retrospectively analyzed. Results:
The study nurses played very important roles at all links during the
preliminary preparation of IBD drug clinical trials, the whole-process
management after project initiation, and the later work of project conclusion. Conclusions:
As direct participants in drug clinical trials, study nurses play a very
important role in ensuring standardization of the trial process, safeguarding
patient’s rights and safety, and assisting investigators in carrying out study
works smoothly.
References
[1]
Wang, Y. and Ouyang, Q. (2007) APDW 2004 Chinese IBD Working Group. Ulcerative Colitis in China: Retrospective Analysis of 3100 Hospitalized Patients. Journal of Gastroenterology and Hepatology, 22, 1450-1455. https://doi.org/10.1111/j.1440-1746.2007.04873.x
[2]
Inflammatory Bowel Disease Group (2018) Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease. Chinese Journal of Digestion, 38, No. 5.
[3]
Pouillon, L., Bossuyt, P. and Peyrin-Biroulet, L. (2016) Considerations, Challenges and Future of Anti-TNF Therapy in Treating Inflammatory Bowel Disease. Expert Opinion on Biological Therapy, 16, 1277-1290. https://doi.org/10.1080/14712598.2016.1203897
[4]
Roda, G., Jharap, B., Neeraj, N. and Colombel, J.F. (2016) Loss of Response to Anti-TNFs: Definition, Epidemiology, and Management. Clinical and Translational Gastroenterology, 7, e135. https://doi.org/10.1038/ctg.2015.63
[5]
Sun, P.J. (2020) Research Progress of Biological Agents and Small-Molecule Drugs for the Treatment of Inflammatory Bowel Disease. Journal of Internal Medicine Concepts & Practice, 15, No. 2.
[6]
Ocker, B.M. and Plank, D.M. (2000) The Research Nurse Role in a Clinical-Based Oncology Research Setting. Cancer Nursing, 23, 286-294. https://doi.org/10.1097/00002820-200008000-00005
[7]
Davis, A.M., Hull, S.C., Grady, C., et al. (2002) The Invisible Hand in Clinical Research: The Study Coordinator’s Critical Role in Human Subjects Protection. The Journal of Law, Medicine & Ethics, 30, 411-419. https://doi.org/10.1111/j.1748-720X.2002.tb00410.x
[8]
Mori, C., Mullen, N. and Hill, E.E. (2007) Describing the Role of the Clinical Research Nurse. Research and Practice, 8, 220-228.
