Journal of Comparative Effectiveness Research welcoming the submission of study design protocols to foster transparency and trust in real-world evidence

doi:10.2217/cer-2022-0197

Editorial

. 2023 Jan;12(1):e220197.

doi: 10.2217/cer-2022-0197. Epub 2022 Dec 21.

Journal of Comparative Effectiveness Research welcoming the submission of study design protocols to foster transparency and trust in real-world evidence

Joanne Walker¹, Laura Dormer¹, Phil Garner¹

Affiliations

PMID: 36541277
PMCID: PMC10288958
DOI: 10.2217/cer-2022-0197

Editorial

Journal of Comparative Effectiveness Research welcoming the submission of study design protocols to foster transparency and trust in real-world evidence

Joanne Walker et al. J Comp Eff Res. 2023 Jan.

. 2023 Jan;12(1):e220197.

doi: 10.2217/cer-2022-0197. Epub 2022 Dec 21.

Authors

Joanne Walker¹, Laura Dormer¹, Phil Garner¹

Affiliation

¹ Becaris Publishing Ltd, Royston, Hertfordshire, UK.

PMID: 36541277
PMCID: PMC10288958
DOI: 10.2217/cer-2022-0197

No abstract available

Keywords: Journal of Comparative Effectiveness Research; RCT; RWD; RWE; guidelines; natural history study; protocol; randomized controlled trial; real-world data; real-world evidence; single-arm trial.

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Conflict of interest statement

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Protocol publication rate and comparison between article, registry and protocol in RCTs.
Mathieu S, Bouillon-Minois JB, Renard Triché L, Coudeyre E, Ingrid C, Thomas F, Laporte C, Moisset X, Samalin L, Villatte G, Pereira B; Methodology And Evidence Statistics for Transparency in medical Research and Outcome reporting (MAESTRO) working group. Mathieu S, et al. BMC Med Res Methodol. 2025 Feb 1;25(1):31. doi: 10.1186/s12874-025-02471-y. BMC Med Res Methodol. 2025. PMID: 39893396 Free PMC article.

References

1. Hopewell S, Boutron I, Chan AW et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat. Med. 28(9), 1740–1743 (2022). - PubMed
1. Spahr A, Rosli Z, Legault M et al. The LORIS MyeliNeuroGene rare disease database for natural history studies and clinical trial readiness. Orphanet J. Rare Dis. 16(1), 328 (2021). - PMC - PubMed
1. US Food and Drug Administration. Rare diseases: natural history studies for drug development. www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-di...
1. Wang SV, Pinheiro S, Hua W et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. Brit. Med. J. 372, m4856 (2021). - PMC - PubMed
1. ISPOR. Real-world evidence transparency initiative. www.ispor.org/strategic-initiatives/real-world-evidence/real-world-evide...

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[1] Hopewell S, Boutron I, Chan AW et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat. Med. 28(9), 1740–1743 (2022). - PubMed

[2] Hopewell S, Boutron I, Chan AW et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat. Med. 28(9), 1740–1743 (2022). - PubMed

[3] Spahr A, Rosli Z, Legault M et al. The LORIS MyeliNeuroGene rare disease database for natural history studies and clinical trial readiness. Orphanet J. Rare Dis. 16(1), 328 (2021). - PMC - PubMed

[4] Spahr A, Rosli Z, Legault M et al. The LORIS MyeliNeuroGene rare disease database for natural history studies and clinical trial readiness. Orphanet J. Rare Dis. 16(1), 328 (2021). - PMC - PubMed

[5] US Food and Drug Administration. Rare diseases: natural history studies for drug development. www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-di...

[6] US Food and Drug Administration. Rare diseases: natural history studies for drug development. www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-di...

[7] Wang SV, Pinheiro S, Hua W et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. Brit. Med. J. 372, m4856 (2021). - PMC - PubMed

[8] Wang SV, Pinheiro S, Hua W et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. Brit. Med. J. 372, m4856 (2021). - PMC - PubMed

[9] ISPOR. Real-world evidence transparency initiative. www.ispor.org/strategic-initiatives/real-world-evidence/real-world-evide...

[10] ISPOR. Real-world evidence transparency initiative. www.ispor.org/strategic-initiatives/real-world-evidence/real-world-evide...

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Journal of Comparative Effectiveness Research welcoming the submission of study design protocols to foster transparency and trust in real-world evidence

Affiliation

Journal of Comparative Effectiveness Research welcoming the submission of study design protocols to foster transparency and trust in real-world evidence

Authors

Affiliation

Conflict of interest statement

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