Factors associated with recruitment success in the phase 2a study of aztreonam-avibactam development programme: a descriptive qualitative analysis among sites in Spain
Rosa M Jimenez-Rodriguez, Guillermo Martín-Gutiérrez, Silvia Jiménez-Jorge, Clara M Rosso-Fernández, Luis Tallón-Aguilar, Cristina Roca-Oporto, Javier Padillo, Alison Luckey, Angela Cano, José López-Ruiz, Silvia Gómez-Zorrilla, Jaime Bonnín-Pascual, Lucía Boix-Palop, José Miguel Montejo, Julian Torre-Cisneros, José Miguel Cisneros, Rosa M Jimenez-Rodriguez, Guillermo Martín-Gutiérrez, Silvia Jiménez-Jorge, Clara M Rosso-Fernández, Luis Tallón-Aguilar, Cristina Roca-Oporto, Javier Padillo, Alison Luckey, Angela Cano, José López-Ruiz, Silvia Gómez-Zorrilla, Jaime Bonnín-Pascual, Lucía Boix-Palop, José Miguel Montejo, Julian Torre-Cisneros, José Miguel Cisneros
Abstract
Objective: Successful clinical trials are subject to recruitment. Recently, the REJUVENATE trial, a prospective phase 2a open-label, single-arm interventional clinical trial conducted within the Innovative Medicines Initiative-supported Combatting Bacterial Resistance in Europe-Carbapenem Resistance project, was published, with 85% of the recruitment performed in Spain. We analysed the recruitment success in this trial by establishing a model of recruitment practice.
Methods: A descriptive qualitative study was performed from May 2016 to October 2017 at 10 participating Spanish centres. Data were extracted from: (1) feasibility questionnaires to assess the centre's potential for patient enrolment; (2) delegation of responsibility records; (3) pre-screening records including an anonymised list of potentially eligible and (4) screening and enrolment records. A descriptive analysis of the features was performed by the participating centre. Pearson's and Spearman's correlation coefficients were calculated to determine factors of recruitment success.
Results: The highest recruitment rate was observed in Hospitals 3 and 6 (58.8 and 47.0 patients per month, respectively). All the study teams were multidisciplinary with a median of 15 members (range: 7-22). Only Hospitals 3, 5 and 6 had dedicated nursing staff appointed exclusively to this study. Moreover, in those three hospitals and in Hospital 9, the study coordinator performed exclusive functions as a research planner, and did not assume these functions for the other hospitals. The univariate analysis showed a significant association between recruitment success and months of recruitment (p=0.024), number of staff (p<0.001), higher number of pharmacists (p=0.005), infectious disease specialists (p<0.001), the presence of microbiologist in the research team (p=0.018) and specifically dedicated nursing staff (p=0.036).
Conclusions: The existence of broad multidisciplinary teams with staff dedicated exclusively to the study as well as the implementation of a well-designed local patient assessment strategy were the essential optimisation factors for recruitment success in Spain.
Trial registration number: NCT02655419; EudraCT 2015-002726-39; analysis of pre-screened patients.
Keywords: clinical trials; diagnostic microbiology; microbiology; protocols & guidelines; statistics & research methods.
Conflict of interest statement
Competing interests: Alison Luckey was Pfizer UK Ltd employee at the time of the study.
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Figures
References
- Caldwell PHY, Hamilton S, Tan A, et al. . Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med 2010;7:e1000368. 10.1371/journal.pmed.1000368
- Daykin A, Clement C, Gamble C, et al. . ‘Recruitment, recruitment, recruitment’ – the need for more focus on retention: a qualitative study of five trials. Trials 2018;19:76. 10.1186/s13063-018-2467-0
- Treweek S, Lockhart P, Pitkethly M, et al. . Methods to improve recruitment to randomised controlled trials: cochrane systematic review and meta-analysis. BMJ Open 2013;3:e002360. 10.1136/bmjopen-2012-002360
- McDonald AM, Knight RC, Campbell MK, et al. . What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006;7:9. 10.1186/1745-6215-7-9
- Sheridan R, Martin-Kerry J, Hudson J, et al. . Why do patients take part in research? an overview of systematic reviews of psychosocial barriers and facilitators. Trials 2020;21:259. 10.1186/s13063-020-4197-3
- Isaksson E, Wester P, Laska AC, et al. . Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel. Trials 2019;20:618. 10.1186/s13063-019-3737-1
- Kaur G, Smyth RL, Williamson P. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials. Trials 2012;13:218. 10.1186/1745-6215-13-218
- Fletcher B, Gheorghe A, Moore D, et al. . Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012;2:e000496. 10.1136/bmjopen-2011-000496
- Sin J, Henderson C, Spain D, et al. . What factors influence successful recruitment of siblings of individuals with first episode psychosis to e-health interventions? A qualitative study. Health Expect 2017;20:696–704. 10.1111/hex.12508
- Mahmud A, Zalay O, Springer A, et al. . Barriers to participation in clinical trials: a physician survey. Curr Oncol 2018;25:119–25. 10.3747/co.25.3857
- Tournoux C, Katsahian S, Chevret S, et al. . Factors influencing inclusion of patients with malignancies in clinical trials. Cancer 2006;106:258–70. 10.1002/cncr.21613
- Kenyon S, Rhodes A, Taylor D. A recipe for successful recruitment to a randomised controlled trial. MDIRS Midwifery Digest 2005;15:16e19.
- Huang GD, Bull J, Johnston McKee K, et al. . Clinical trials recruitment planning: a proposed framework from the clinical trials transformation initiative. Contemp Clin Trials 2018;66:74–9. 10.1016/j.cct.2018.01.003
- Gkioni E, Rius R, Dodd S, et al. . A systematic review describes models for recruitment prediction at the design stage of a clinical trial. J Clin Epidemiol 2019;115:141–9. 10.1016/j.jclinepi.2019.07.002
- Skea ZC, Treweek S, Gillies K. 'It's trying to manage the work': a qualitative evaluation of recruitment processes within a UK multicentre trial. BMJ Open 2017;7:e016475. 10.1136/bmjopen-2017-016475
- Cornely OA, Cisneros JM, Torre-Cisneros J, et al. . Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study. J Antimicrob Chemother 2020;75:618–27. 10.1093/jac/dkz497
- Team RC . R: a language and environment for statistical computing, 2013. Available: [Accessed 17 May 2020].
- Campillo-Gimenez B, Buscail C, Zekri O, et al. . Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials 2015;16:15. 10.1186/s13063-014-0535-7
- Adams M, Caffrey L, McKevitt C. Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre. Health Res Policy Sys 2015;13:8. 10.1186/1478-4505-13-8
- de Salis I, Tomlin Z, Toerien M, et al. . Using qualitative research methods to improve recruitment to randomized controlled trials: the quartet study. J Health Serv Res Policy 2008;13:92–6. 10.1258/jhsrp.2008.008028
- Donovan JL, Paramasivan S, de Salis I, et al. . Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials 2014;15:5. 10.1186/1745-6215-15-5
- Lawton J, Snowdon C, Morrow S, et al. . Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals. Trials 2016;17:195. 10.1186/s13063-016-1323-3
- Prout H, Butler C, Kinnersley P, et al. . A qualitative evaluation of implementing a randomized controlled trial in general practice. Fam Pract 2003;20:675–81. 10.1093/fampra/cmg609
- Good MJ, Lubejko B, Humphries K, et al. . Measuring clinical trial-associated workload in a community clinical oncology program. J Oncol Pract 2013;9:211–5. 10.1200/JOP.2012.000797
Source: PubMed