Academic Journal
Review of the recruitment process for a large investigator-initiated trial in early Parkinson’s disease
| العنوان: | Review of the recruitment process for a large investigator-initiated trial in early Parkinson’s disease |
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| المؤلفون: | Verschuur, C. V. M., Donovan, J. L., de Bie, R. M. A. |
| المساهمون: | ZonMw, Stichting ParkinsonFonds, Stichting Parkinson Nederland, Parkinson Vereniging |
| المصدر: | Trials ; volume 23, issue 1 ; ISSN 1745-6215 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2022 |
| الوصف: | Introduction Organizing and executing a large clinical trial is a complex process, and often recruitment targets are not met. We describe the organization of the Levodopa in the Early Parkinson’s disease (LEAP) trial and the results of an external assessment of the recruitment process. Methods Several strategies were used to ensure that recruitment for the trial was effective and efficient. We analyzed the patterns in referrals, inclusions, and non-inclusions to investigate whether there were bottlenecks in the referral and inclusion process. For the external assessment of the recruitment process, the QuinteT Recruitment Intervention (QRI-Two) was used retrospectively, focusing on finding possible issues impeding recruitment that are less easily recognized. Results Recruitment took 57 months, which was 27 months longer than initially expected. 6.8% of the estimated eligible patients in the Netherlands were included. The number of referrals differed widely between participating centers and regions in the Netherlands, with the region of the principal study center having the most referrals. Reasons of exclusion varied across regions, as in some regions more patients already started, wanted to start, or did not want to start with Parkinson medication compared to other regions. Discussion Executing a large, investigator-initiated clinical trial on a limited budget still remains possible by focusing on minimizing administrative and organizational procedures. Our study suggests that centers with closer institutional ties to a principal study center tend to have a higher referral rate. The review of the LEAP trial recruitment strategies and data using the QRI-Two suggested that the variations in referrals and reasons of non-inclusion could indicate the presence of issues related to clinical equipoise, patient eligibility, or study presentation. Integrating a recruitment intervention could have explored issues with study presentation and equipoise that might have increased recruitment efficiency. Trial ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1186/s13063-022-06052-y |
| DOI: | 10.1186/s13063-022-06052-y.pdf |
| DOI: | 10.1186/s13063-022-06052-y/fulltext.html |
| الاتاحة: | http://dx.doi.org/10.1186/s13063-022-06052-y https://link.springer.com/content/pdf/10.1186/s13063-022-06052-y.pdf https://link.springer.com/article/10.1186/s13063-022-06052-y/fulltext.html |
| Rights: | https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.1D032ACF |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-022-06052-y |
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