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Editorial
21 December 2022

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

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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).
2.
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).
3.
US Food and Drug Administration. Rare diseases: natural history studies for drug development. www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-diseases-natural-history-studies-drug-development
4.
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).
6.
Wang SV, Pottegård A, Crown W et al. HARmonized Protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a Good Practices Report of a joint ISPE/ISPOR Task Force. Value Health 25(10), 1663–1672 (2022).
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).
8.
Seewald MJ, Plumb JM, Gutierrez B et al. Strengthening pharma's contract with society: the value of trusted partnerships between pharma and healthcare facilitated by real-world data. J. Comp. Eff. Res. 9(3), 155–159 (2020).
9.
Orsini LS, Berger M, Crown W et al. Improving transparency to build trust in real-world secondary data studies for hypothesis testing – why, what, and how: recommendations and a road map from the Real-World Evidence Transparency Initiative. Value Health 23(9), 1128–1136 (2020).