A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials
<p><strong>Objectives:</strong><br /> To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and the hurdles that exist in obtaining them.</p><br /> <p><strong>St...
| Main Authors: | , , , , , , , , |
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| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2020
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| _version_ | 1797054527929581568 |
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| author | Speich, B Logullo, P Deuster, S Marian, IR Moschandreas, J Herav, AT Gloy, V Briel, M Hopewell, S |
| author2 | MAking Randomised Trials Affordable (MARTA) Group |
| author_facet | MAking Randomised Trials Affordable (MARTA) Group Speich, B Logullo, P Deuster, S Marian, IR Moschandreas, J Herav, AT Gloy, V Briel, M Hopewell, S |
| author_sort | Speich, B |
| collection | OXFORD |
| description | <p><strong>Objectives:</strong><br />
To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and the hurdles that exist in obtaining them.</p><br />
<p><strong>Study Design and Setting:</strong><br />
PubMed was searched for recently published noncommercial, placebo-controlled randomized drug trials. Corresponding authors were invited to participate in an online survey.</p><br />
<p><strong>Results:</strong><br />
From 423 eligible articles, 109 (26%) corresponding authors (partially) participated. Twenty-one of 102 (21%) authors reported that the placebos used were not matching (correctly labeled in only one publication). The main sources in obtaining placebos were hospital pharmacies (32 of 107; 30%) and the manufacturer of the study drug (28 of 107; 26%). RCTs with a hypothesis in the interest of the manufacturer of the study drug were more likely to have obtained placebos from the drug manufacturer (18 of 49; 37% vs. 5 of 29; 17%). Median costs for placebos and packaging were US$ 58,286 (IQR US$ 2,428– US$ 160,770; n = 24), accounting for a median of 10.3% of the overall trial budget.</p><br />
<p><strong>Conclusion:</strong><br />
Although using matching placebos is widely accepted as a basic practice in RCTs, there seems to be no standard source to acquire them. Obtaining placebos requires substantial resources, and using nonmatching placebos is common.</p> |
| first_indexed | 2024-03-06T18:58:27Z |
| format | Journal article |
| id | oxford-uuid:12afe7dd-ecec-42cc-8bbf-1941330662dd |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T18:58:27Z |
| publishDate | 2020 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:12afe7dd-ecec-42cc-8bbf-1941330662dd2022-03-26T10:09:19ZA meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:12afe7dd-ecec-42cc-8bbf-1941330662ddEnglishSymplectic ElementsElsevier2020Speich, BLogullo, PDeuster, SMarian, IRMoschandreas, JHerav, ATGloy, VBriel, MHopewell, SMAking Randomised Trials Affordable (MARTA) Group<p><strong>Objectives:</strong><br /> To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), from where they are obtained, and the hurdles that exist in obtaining them.</p><br /> <p><strong>Study Design and Setting:</strong><br /> PubMed was searched for recently published noncommercial, placebo-controlled randomized drug trials. Corresponding authors were invited to participate in an online survey.</p><br /> <p><strong>Results:</strong><br /> From 423 eligible articles, 109 (26%) corresponding authors (partially) participated. Twenty-one of 102 (21%) authors reported that the placebos used were not matching (correctly labeled in only one publication). The main sources in obtaining placebos were hospital pharmacies (32 of 107; 30%) and the manufacturer of the study drug (28 of 107; 26%). RCTs with a hypothesis in the interest of the manufacturer of the study drug were more likely to have obtained placebos from the drug manufacturer (18 of 49; 37% vs. 5 of 29; 17%). Median costs for placebos and packaging were US$ 58,286 (IQR US$ 2,428– US$ 160,770; n = 24), accounting for a median of 10.3% of the overall trial budget.</p><br /> <p><strong>Conclusion:</strong><br /> Although using matching placebos is widely accepted as a basic practice in RCTs, there seems to be no standard source to acquire them. Obtaining placebos requires substantial resources, and using nonmatching placebos is common.</p> |
| spellingShingle | Speich, B Logullo, P Deuster, S Marian, IR Moschandreas, J Herav, AT Gloy, V Briel, M Hopewell, S A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title | A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title_full | A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title_fullStr | A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title_full_unstemmed | A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title_short | A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials |
| title_sort | meta research study revealed several challenges in obtaining placebos for investigator initiated drug trials |
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