Predicting of patient’s enrollment to multicentral international clinical trials of II–III phase

Svyatoslav S. Milovanov


Many international multicenter trials ending by fail due to fail to recruitment of patients. Objective was to find the integrated and simple value for the assessing the possibility of recruitment in particular sites on the feasibility stage. Design consisted of retrospective review of the selected parameters since feasibility stage to final report of studies conducting in a few sites since 2008 to 2017 year. It was also selected empirical range of the sites. Collection of data was done from the private experience of authors. The integrated and simple values for the assessment of the possibility of recruitment in particular sites on the feasibility stage were calculated. Recruitment of patient as an integrated part of site’s work could be calculated as the beginning of running study on particular site which can lead to increasing of study success and could be used as an embedded value in artificial intelligence for both virtual and real studies. We titled this “calculated type of site on enrollment (CTSE)”.


Clinical trial, NAFLD, NASH

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Jaimes AL, Martinez SZ, Coello CA. An Introduction to Multiobjective Optimization Techniques. Nova Science Publishers, Inc. 2009;1-26.

Pearl A, Wright S, Gamble G, Doughty R, Sharpe N. Randomised trials in general practice: a New Zealand experience in recruitment. N Zeal Med J. 2003;116:6817.

Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, et al. Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013;166(3):429-34.

Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, et al. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014;311(15):1515-25.

McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.

Thoma A, Farrokhyar F, McKnight L, Bhandari M. How to optimize patient recruitment. Can J Surg. 2010;53:205-10.

Rathore APS. Getting a Handle on Clinical Trial Costs. Available at: doc/getting-a-handle-on-clinical-trial-costs-0001. Accessed on 25 April 2019.

Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trials. 2015;12:77-83.

Cryder C, London AJ, Volpp K, Lowenstein G. Informative inducement: study payment as a signal of risk. Soc Sci Med. 2010;70:455-64.

Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, et al. Perceptions of cancer patients and their physicians involved in phase 1 trials. J Clin Oncol. 1995;13:1062-72.

Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials. 2017;18:122.

Bennette CS, Ramsey SD, McDermott CL, Carlson JJ, Basu A, Veenstra DL, Predicting low accrual in the National Cancer Institute's cooperative group clinical trials. J Natl Cancer Inst. 2016;108.

Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Comm. 2018;11:15-64.

Getz KA. Impact of In-Pharmacy Education on Patients' Knowledge and Attitudes About Clinical Trials. Ther Innov Regul Sci. 2013;47(3):336-40.

Institute of Medicine. Committee on Cancer Clinical Trials. National Academic Press, Washington D.C. 2010.

Slomka J, McCurdy S, Ratliff EA, Timpson S, Williams ML. Perceptions of financial payment for research participation among African-American drug users in HIV studies. J Gen Intern Med. 2007;22(10):1403-9.

Verster J, Van de Loo AJ, Roehrs T. Roth, Are clinical trial participants representative for patients with insomnia? Sleep. 2017;40:148.

Dinkel J. Keep Your Patient Recruitment Strategy Hot This Summer. Available at:[Keep%20Your%20Patient%20Re] Accessed on 27 October 2020.

Stensland KD, McBride RB, Latif A, Wisnivesky J, Hendricks R, Roper N, et al. Adult cancer clinical trials that fail to complete: an epidemic? J Natl Cancer Inst. 2014;106.

Levett KM, Roberts CL, Simpson JM, Morris JM. Site-specific predictors of successful recruitment to a perinatal clinical trial. Clin Trials. 2014;11(5):584-9.

Hörster L, Schlenk RF, Stadler M, Gabriel M, Thol F, Schildmann J, et al. Cost-effectiveness of methods in personalized medicine. Results of a decision-analytic model in patients with acute myeloid leukemia with normal karyotype. Leuk Res. 2017;62:84-90.

Byrne MM, Tannenbaum SL, Glück S, Hurley J, Antoni M. Participation in cancer clinical trials: why are patients not participating? Med Decis Making. 2014;34(1):116-26.

Fouad MN, Lee JY, Catalano PJ, Vogt TM, Zafar SY, West DW, et al. Enrollment of patients with lung and colorectal cancers onto clinical trials. J Oncol Pract. 2013;9(2):40-7.

Alsumidaie M. The Science of Engagement in Clinical Trial Subject Enrollment. Available at: /819243?contextCategoryId=49914&goback=%2Egde_765517_member_262021293. Accessed on 27 October 2020.

Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. 2018;178(11):1451-7.

De Wit NJ, Quartero AO, Zuithoff AP, Numans ME. Participation and successful patient recruitment in primary care. J Fam Pract. 2001;50(11):976.

Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009;(3):MR000008.

Jones RH, White H, Velazquez EJ, Shaw LK, Pietrobon R, Panza JA, et al. STICH (Surgical Treatment for Ischemic Heart Failure) trial enrollment. J Am Coll Cardiol. 2010;56(6):490-8.

Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess. 1999;3(20):1-143.

Van den Bor RM, Grobbee DE, Oosterman BJ, Vaessen PWJ, Roes KCB. Predicting enrollment performance of investigational centers in phase III multi-center clinical trials. Contemp Clin Trials Commun. 2017;7:208-16.

Feller S. One in Four Cancer Trials Fails to Enroll Enough Participants. 2015. Available ta: Accessed on 25 September 2020.

Wilson S, Bremner A, Hauck Y, Finn J. The effect of nurse staffing on clinical outcomes of children in hospital: a systematic review. Int J Evid Base Healthc. 2011;9:97-121.

Dickson S, Logan J, Hagen S, Stark D, Glazener C, McDonald AM, McPherson G. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings. Trials. 2013;14:389.

Milovanov S. Analysis of the rate of patient recruitment in international multicenter clinical studies. Questions of student science. 2019;33(1):19-25.

Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials. 2016;13(2):117-26.

Yen W. How Long and How Far Do Adults Travel for Primary Care? Research Brief No. 70 Washington State Health Services Research Project. 2013.

Sateren WB, Trimble EL, Abrams J, Brawley O, Breen N, Ford L, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20(8):2109-17.

Michalewicz Z, Fogel DB. How to Solve it: Modern Heuristics. Second ed. Springer, Berlin. 2004;444-9.