Factors, influencing to the recruitment of international multicenter clinical trials of II–III phases
https://doi.org/10.37489/2588-0519-2022-4-13-23
Abstract
Recruiting patients to a clinical trial is a process with many limitations. First of all, the time-limited and lengthening of the patient recruitment process in time increases the risk of failure of the entire study. In addition to the time factor, many other factors affect the recruitment of patients. The influence of factors is multidirectional and one factor can affect both positively and negatively the recruitment of patients. We have considered some of the factors within the framework of our proposed classification. Materials and methods. A retrospective analysis of 4 international multicenter clinical trials (MSCI) of phases II–III on the recruitment of patients, depending on the influence of factors, was carried out. The purpose of the study. To consider the influence of various factors on the set of patients by changing the set of patients and some other parameters and indicators. Statistical analysis. Descriptive statistics with typing. Results. The factors are classified into two groups and their influence on the recruitment of patients is considered. Discussion. According to the literature, the authors have developed a large number of classifications of groups, and we have proposed our own classification.
About the Author
S. S. Milovanov
Sole entrepreneur Milovanov Svyatoslav Sergeevich
Russian Federation
Russian Federation
Milovanov Svyatoslav S., Cand. Sci. (Med.), independent researcher
Moscow
References
1. Chin Feman SP, Nguyen LT, Quilty MT, Kerr CE, Nam BH, Conboy LA, Singer JP, Park M, Lembo A, Kaptchuk TJ, Davis RB. Effectiveness of recruitment in clinical trials: An analysis of methods used in a trial for irritable bowel syndrome patients. Contemporary Clinical Trials. 2008;29(2):241–51. doi:10.1016/j.cct.2007.08.004
2. Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018;11:156–64. doi:10.1016/j.conctc.2018.08.001
3. van den Bora RM, Grobbeea DE, Oostermana BJ, Vaessena PWJ, Roes KCB. Predicting enrollment performance of investigational centers in phase III multi-center clinical trials. Contemp Clin Trials Commun. 2017;7:208–16. doi:10.1016/j.conctc.2017.07.004
4. Schoenberger JA. Recruitment in the Coronary Drug Project and the Aspirin Myocardial Infarction Study. Clin Pharmacol Ther. 1979;25(5 Pt 2): 681–4. doi:10.1002/cpt1979255part2681
5. Yang E, O’Donovan C, Phillips J, Atkinson L, Ghosh K, Agrafiotis DK. Quantifying and visualizing site performance in clinical trials. Contemp Clin Trials Commun. 2018;9:108–14. doi:10.1016/j.conctc.2018.01.005
6. Berenson A (2005, November 14). Big drug makers see sales decline with their image. New York Times. Retrieved March 18, 2006. Available at: http://www.nytimes.com. Accessed November 03, 2022.
7. Hawthorne F (2004, December). How big pharma blew it: bad choices and PR gaffes have finally caught up with the drug industry. The Chief Executive. Retrieved March 18, 2006. Available at: https://www.thefreelibrary.com/How+Big+Pharma+blew+it%3a+bad+choices+and+PR+gaffes+have+finally+caught...-a0126397385. Accessed October 07, 2022.
8. Bachenheimer JF, Brescia BA. Reinventing Patient Recruitment Revolutionary Ideas for Clinical Trial Success. Gower Publishing, Ltd., 2007.
9. Kibby M. Patient recruitment feasibility. Applied Clinical Trials. 2011;20(6):80–7.
10. Terheyden JH, Behning C, Lüning A, et al. Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study. BMC Medical Research Methodology. 2021;21(54). doi:10.1186/s12874-021-01243-8
11. Wolf L. Expanding good recruitment practice. Journal of GXP compliance. 2007 Jan;36–49.
12. Croke G. Recruitment for the National Cooperative Gallstone Study. Clin Pharmacol Ther. 1979;25(5, part 2):691–4. doi:10.1002/cpt1979255part2691
13. Yen W. How long and how far do adults travel and will adults travel for primary care? Washington State Office of Financial Management; 2013. Research Brief No. 70. Available at: https://www.ofm.wa.gov/sites/default/files/public/legacy/researchbriefs/2013/brief070.pdf. Accessed October 07, 2022.
Review
For citations:
Milovanov S.S. Factors, influencing to the recruitment of international multicenter clinical trials of II–III phases. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2022;(4):13-23. (In Russ.) https://doi.org/10.37489/2588-0519-2022-4-13-23
Views:
592
Email this article 