Research ExplorerPublicationsRegulatory delays in a multinational clinical stroke trial

Regulatory delays in a multinational clinical stroke trial

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Regulatory delays in a multinational clinical stroke trial. / de Jonge, Jeroen C; Reinink, Hendrik; Colam, Bridget; Alpers, Iris; Ciccone, Alfonso; Csiba, Laszlo; Kõrv, Janika; Kurkowska-Jastrzebska, Iwona; Macleod, Malcolm R; Ntaios, George; Thomalla, Götz; Bath, Philip M; van der Worp, H Bart.

In: EUR STROKE J, Vol. 6, No. 2, 06.2021, p. 120-127.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

de Jonge, JC, Reinink, H, Colam, B, Alpers, I, Ciccone, A, Csiba, L, Kõrv, J, Kurkowska-Jastrzebska, I, Macleod, MR, Ntaios, G, Thomalla, G, Bath, PM & van der Worp, HB 2021, 'Regulatory delays in a multinational clinical stroke trial', EUR STROKE J, vol. 6, no. 2, pp. 120-127. https://doi.org/10.1177/23969873211004845

APA

de Jonge, J. C., Reinink, H., Colam, B., Alpers, I., Ciccone, A., Csiba, L., Kõrv, J., Kurkowska-Jastrzebska, I., Macleod, M. R., Ntaios, G., Thomalla, G., Bath, P. M., & van der Worp, H. B. (2021). Regulatory delays in a multinational clinical stroke trial. EUR STROKE J, 6(2), 120-127. https://doi.org/10.1177/23969873211004845

Vancouver

de Jonge JC, Reinink H, Colam B, Alpers I, Ciccone A, Csiba L et al. Regulatory delays in a multinational clinical stroke trial. EUR STROKE J. 2021 Jun;6(2):120-127. https://doi.org/10.1177/23969873211004845

Bibtex

@article{c50f57c431794956bb8a1b9c1470d349,
title = "Regulatory delays in a multinational clinical stroke trial",
abstract = "INTRODUCTION: The initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce.MATERIALS AND METHODS: We assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months.RESULTS: The median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586-1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93-293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = -0.002; p = 0.02).CONCLUSION: In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.",
author = "{de Jonge}, {Jeroen C} and Hendrik Reinink and Bridget Colam and Iris Alpers and Alfonso Ciccone and Laszlo Csiba and Janika K{\~o}rv and Iwona Kurkowska-Jastrzebska and Macleod, {Malcolm R} and George Ntaios and G{\"o}tz Thomalla and Bath, {Philip M} and {van der Worp}, {H Bart}",
note = "{\textcopyright} European Stroke Organisation 2021.",
year = "2021",
month = jun,
doi = "10.1177/23969873211004845",
language = "English",
volume = "6",
pages = "120--127",
journal = "EUR STROKE J",
issn = "2396-9873",
publisher = "SAGE Publications",
number = "2",

}

RIS

TY - JOUR

T1 - Regulatory delays in a multinational clinical stroke trial

AU - de Jonge, Jeroen C

AU - Reinink, Hendrik

AU - Colam, Bridget

AU - Alpers, Iris

AU - Ciccone, Alfonso

AU - Csiba, Laszlo

AU - Kõrv, Janika

AU - Kurkowska-Jastrzebska, Iwona

AU - Macleod, Malcolm R

AU - Ntaios, George

AU - Thomalla, Götz

AU - Bath, Philip M

AU - van der Worp, H Bart

N1 - © European Stroke Organisation 2021.

PY - 2021/6

Y1 - 2021/6

N2 - INTRODUCTION: The initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce.MATERIALS AND METHODS: We assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months.RESULTS: The median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586-1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93-293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = -0.002; p = 0.02).CONCLUSION: In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.

AB - INTRODUCTION: The initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce.MATERIALS AND METHODS: We assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months.RESULTS: The median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586-1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93-293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = -0.002; p = 0.02).CONCLUSION: In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.

U2 - 10.1177/23969873211004845

DO - 10.1177/23969873211004845

M3 - SCORING: Journal article

C2 - 34414286

VL - 6

SP - 120

EP - 127

JO - EUR STROKE J

JF - EUR STROKE J

SN - 2396-9873

IS - 2

ER -