Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands

Bogert, Cornelis A. van den; Souverein, Patrick C.; Brekelmans, C. T. M.; Janssen, Sabine; Koëter, Gerard H.; Leufkens, Hubert G. M.; Bouter, Lex M.

doi:10.1016/j.jclinepi.2017.05.001

Cited by 15 publications

(10 citation statements)

References 34 publications

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“…Despite an increase in vaccine development [4] with more than 7 300 vaccine trials registered in clinical trial.gov [5], vaccine clinical development remains time -and cost-consuming [6]. Despite lack of data on preventive vaccine trials (PVTs), recruitment failure is the primary reason for discontinuation in clinical drug trials, occurring in one out of five trials [7]. Due to the cost associated with the clinical development of a vaccine and the public health benefits expected, reaching optimal recruitment in PVTs is crucial.…”

Section: Introductionmentioning

confidence: 99%

Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

Detoc

Launay

Dualé

et al. 2019

Vaccine

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Section: Introductionmentioning

confidence: 99%

Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

Detoc

Launay

Dualé

et al. 2019

Vaccine

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“…Poor recruitment has been reported to be the most important reason for clinical trial delays, 1 ultimately also delaying access to new treatments and increasing drug development costs. 2 In earlier reports, only 31% of the evaluated clinical trials met their original recruitment targets on time 3 and 19% of the initiated sites were found to be zero-recruiters.…”

Section: Introductionmentioning

confidence: 99%

Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries

et al. 2021

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Introduction: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. Methods: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. Results: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. Conclusion: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.

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“…The development of an effective vaccine against SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), marks one of the highest priorities during the ongoing pandemic. However, recruitment of participants for clinical phase I vaccine trials can be challenging, and recruitment failure is among the most common reasons for discontinuation in clinical trials [ 1 ]. The media plays an important role in informing the public and may raise awareness about upcoming vaccine trials [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Characterization of Individuals Interested in Participating in a Phase I SARS-CoV-2 Vaccine Trial

et al. 2021

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The development of an effective vaccine against SARS-CoV-2 marks one of the highest priorities during the ongoing pandemic. However, recruitment of participants for clinical trials can be challenging, and recruitment failure is among the most common reasons for discontinuation in clinical trials. From 20 May 2020, public announcements about a planned phase I trial of the vaccine candidate MVA-SARS-2-S against SARS-CoV-2 began, and interested individuals started contacting the study team via designated e-mail. All emails received from these individuals between 20 May 2020–30 September 2020 were assessed. Of the 2541 interested volunteers, 62% contacted the study team within three days after the first media announcement. The average age was 61 years (range 16–100), 48% of volunteers were female and 52% male. A total of 274, 186, and 53 individuals, respectively, reported medical pre-conditions, were health-care workers, or had frequent inter-person contacts. In conclusion, we report a high number of volunteers, with a considerable percentage stating factors for an elevated risk to acquire COVID-19 or develop severe disease. Factors such as media coverage and the perception of a disease as an acute threat may influence the individual’s choice to volunteer for a vaccine trial. Our data provide first important insights to better understand reasons to participate in such trials to facilitate trial implementation and recruitment.

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Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands

Abstract: One out of five clinical drug trials is discontinued before the planned trial end, with recruitment failure and futility as the most common reasons. The target sample size of trials should be feasible, and interim analyses should be adequately described in trial protocols.

Cited by 15 publications

References 34 publications

Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries

Characterization of Individuals Interested in Participating in a Phase I SARS-CoV-2 Vaccine Trial

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