Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries
Abstract Background Patient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been comprehensively investigated, although the industry globally conducts...
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06144-9 |
| _version_ | 1817988227916627968 |
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| author | Niina Laaksonen Mia Bengtström Anna Axelin Juuso Blomster Mika Scheinin Risto Huupponen |
| author_facet | Niina Laaksonen Mia Bengtström Anna Axelin Juuso Blomster Mika Scheinin Risto Huupponen |
| author_sort | Niina Laaksonen |
| collection | DOAJ |
| description | Abstract Background Patient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been comprehensively investigated, although the industry globally conducts almost one third of all clinical drug trials. This study explored patient recruitment success and failure factors and the role of electronic health records (EHR) in the recruitment of trial participants in the Nordic countries. Methods A descriptive qualitative interview study was conducted with 21 representatives of the pharmaceutical industry or contract research organizations operating in Finland, Sweden, Denmark, and Norway. The interviews covered 34 clinical pre-market drug trials. Qualitative data were analyzed using inductive content analysis. Results Four main categories were derived to represent both success and failure factors, whereas a fifth category represented only failure factors: (1) sponsor-related (protocol and trial preparation and feasibility evaluations), (2) site/investigator-related (access to patients, motivation, commitment and resources), (3) patient-related recruitment factors (medical need, patients’ role in their care and attitudes towards trials), (4) Sponsor—sites—patients collaboration factors, and (5) start-up related factors. EHR was the most important source of recruitment, utilized in 29 out of 34 trials discussed. Revision of the legislation regulating the secondary use of EHR was highlighted as the most effective measure to facilitate the use of EHR in recruitment of trial participants. Conclusions The industry representatives recognized quite well their own role in contributing to the success or failure of the recruitment: to facilitate recruitment of trial participants, many obstacles can be avoided with better trial preparation and proper feasibility evaluations. As access to patients represents one of the key success or failure factors of recruitment, and as the EHR is regarded the main source of searching for and finding patients, the development of EHR utilization appears to represent a powerful tool to improve patient recruitment. |
| first_indexed | 2024-04-14T00:31:37Z |
| format | Article |
| id | doaj.art-f99e81dff8ef46068c2dcd83b1e1f004 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-14T00:31:37Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f99e81dff8ef46068c2dcd83b1e1f0042022-12-22T02:22:31ZengBMCTrials1745-62152022-05-0123111410.1186/s13063-022-06144-9Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countriesNiina Laaksonen0Mia Bengtström1Anna Axelin2Juuso Blomster3Mika Scheinin4Risto Huupponen5Institute of Biomedicine, University of TurkuPharma Industry FinlandDepartment of Nursing Science, University of TurkuDepartment of Cardiology, University of Turku and Turku University HospitalInstitute of Biomedicine, University of TurkuInstitute of Biomedicine, University of TurkuAbstract Background Patient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been comprehensively investigated, although the industry globally conducts almost one third of all clinical drug trials. This study explored patient recruitment success and failure factors and the role of electronic health records (EHR) in the recruitment of trial participants in the Nordic countries. Methods A descriptive qualitative interview study was conducted with 21 representatives of the pharmaceutical industry or contract research organizations operating in Finland, Sweden, Denmark, and Norway. The interviews covered 34 clinical pre-market drug trials. Qualitative data were analyzed using inductive content analysis. Results Four main categories were derived to represent both success and failure factors, whereas a fifth category represented only failure factors: (1) sponsor-related (protocol and trial preparation and feasibility evaluations), (2) site/investigator-related (access to patients, motivation, commitment and resources), (3) patient-related recruitment factors (medical need, patients’ role in their care and attitudes towards trials), (4) Sponsor—sites—patients collaboration factors, and (5) start-up related factors. EHR was the most important source of recruitment, utilized in 29 out of 34 trials discussed. Revision of the legislation regulating the secondary use of EHR was highlighted as the most effective measure to facilitate the use of EHR in recruitment of trial participants. Conclusions The industry representatives recognized quite well their own role in contributing to the success or failure of the recruitment: to facilitate recruitment of trial participants, many obstacles can be avoided with better trial preparation and proper feasibility evaluations. As access to patients represents one of the key success or failure factors of recruitment, and as the EHR is regarded the main source of searching for and finding patients, the development of EHR utilization appears to represent a powerful tool to improve patient recruitment.https://doi.org/10.1186/s13063-022-06144-9Patient recruitmentClinical trialsSuccess factorsFailureElectronic health recordsNordic countries |
| spellingShingle | Niina Laaksonen Mia Bengtström Anna Axelin Juuso Blomster Mika Scheinin Risto Huupponen Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries Trials Patient recruitment Clinical trials Success factors Failure Electronic health records Nordic countries |
| title | Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries |
| title_full | Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries |
| title_fullStr | Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries |
| title_full_unstemmed | Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries |
| title_short | Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries |
| title_sort | success and failure factors of patient recruitment for industry sponsored clinical trials and the role of the electronic health records a qualitative interview study in the nordic countries |
| topic | Patient recruitment Clinical trials Success factors Failure Electronic health records Nordic countries |
| url | https://doi.org/10.1186/s13063-022-06144-9 |
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