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If no randomized trials exist, clinicians and funders of care can still act on the results from observational RCD and other evidence, but they should consider that treatment effects could be more uncertain and substantially smaller than what RCD studies suggest. Therefore, decisions for widespread adoption and reimbursement of expensive interventions with evidence based entirely on RCD may be best withheld until trial evidence becomes available. Large randomized trials might still be needed to address critically important clinical questions for patient relevant outcomes. 1 77 78

What is already known on this topic

Observational studies using routinely collected data (RCD studies) are increasingly used to inform healthcare decisions when RCTs are not available

However, observational studies have an inherent risk of bias due to confounding by indication

Another difficulty is the accuracy and reliability of routinely collected data

What this study adds

RCD studies systematically and substantially overestimate mortality benefits of medical treatments compared with subsequent trials investigating the same question

Observational RCD studies might not necessarily provide very reliable answers on how to best treat patients; caution is needed to prevent misguided clinical decision making

If no randomized trials exist, clinicians and funders of care should consider that treatment effects are probably more uncertain and substantially smaller than RCD studies suggest; decisions for widespread adoption and reimbursement of expensive interventions might be best withheld until trial evidence becomes available

Footnotes

We thank Hannah Ewald, University of Basel, for support in the risk of bias assessment.

Contributors: LGH and JPAI conceived the study. All authors extracted and analyzed the data and interpreted the results. LGH wrote the first draft and all authors made revisions on the manuscript. All authors read and approved the final version of the paper. JPAI is the guarantor.

Funding: This study was supported by the Commonwealth Fund, a private independent foundation based in New York City. The views presented here are those of the authors and not necessarily those of the Commonwealth Fund, its directors, officers, or staff. The Basel Institute for Clinical Epidemiology and Biostatistics received support from Santésuisse, the umbrella association of Swiss social health insurers. The Meta-Research Innovation Center at Stanford is funded by a grant by the Laura and John Arnold Foundation. The work of JPAI is supported by an unrestricted gift from Sue and Bob O’Donnell. The funders had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript or its submission for publication.

230. See id. at 168 n.22 (suggesting that a tribunal could improve uniformity by gap-filling within the CISG to address the need for a damages remedy for losses caused by wrongful revocation). See also LOOKOFSKY, UNDERSTANDING, supra note 33, at 22 n.79 (commenting on Honnold's eventual "bold" approach to Article 7(2)).

231. Workshop , supra note 127, at 230. See HONNOLD, supra note 79, at 54 (claiming that precontractual issues in franchise relationships likely fall outside the CISG's scope).

232. See HONNOLD, supra note 79, at 54 (stating that culpa in contrahendo issues are so diverse that "they are either dealt with or excluded by provisions of Part II on Formation of Contract").

233. Honnold contrasts the positions that a tribunal might take in relation to the need for a damages remedy for wrongfully revoked offers: either the tribunal or court could develop a remedy pursuant to Article 16(2) through application of general principles in accordance with Article 7(2) or , if the tribunal or court declines such an interpretation, through recourse to the domestic law for such a remedy, but working from the baseline assumption that the revocation was "wrongful" on the basis of the CISG. Id. at 168 n.22. By posing the two courses that a tribunal or court might take as alternatives, Honnold demonstrates precontractual liability under either CISG or domestic law as mutually exclusive.

234. In matters regulated by the CISG, Schlechtriem finds that courts have little leeway in granting remedies based in tort law. Schlechtriem, supra note 6, at 468.

235. Id. ; Peter Schlechtriem, Introduction , in CISG COMMENTARY, supra note 83, at 1, 6-8, (arguing that reliance on domestic remedies could disrupt the CISG's formation rules and remedies).

236. Schlechtriem, supra note 235, at 7. In Borderland , Schlechtriem cites culpa in contrahendo and various forms of tortious misrepresentation as threats. Schlechtriem, supra note 6 at 472, 474.

237. Schlechtriem holds this view in the context of tort-contract overlaps. Schlechtriem, supra note 6, at 470-71.

238. While culpa in contrahendo is considered a contractual doctrine under German law, this classification is not helpful for present purposes. Therefore, it is grouped with other domestic actions as "precontractual" for analytical convenience in this Article.

239. Schlechtriem, supra note 127, at 183; Peter Schlechtriem, Commentary to Article 16 , in CISG COMMENTARY, supra note 83, at 213. Bridge agrees that the integrity of the CISG would be affected if relief for wrongful revocation were to be available under general domestic contract law. BRIDGE, supra note 74, at 73.

240. Professor Joseph Lookofsky, however, questions this assumption due to lack of "persuasive precedents." Lookofsky, Tightrope , supra note 33, at 101.

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Main results

The Council agreed its stance on proposals to reduce risk in the banking industry, strengthening rules on capital requirements and on bank recovery and resolution.

banking

Implementing reforms agreed at international level, the proposals are aimed at ensuring that any outstanding challenges to financial stability are correctly addressed.

Based on the progress achieved on risk reduction, ministers reiterated their commitment to progress on all components, including on risk sharing, cited in the Council's 'roadmap' on banking union. Decisions to advance on the backstop to the EU's single resolution fund will be taken in June 2018.

“The agreement on the banking package today will enable usto make progress on other elements of the banking union”, said Vladislav Goranov, minister for finance of Bulgaria, which currently holds the Council presidency.

“Today’s agreement will send a positive signal to the market. We hope therefore that theEuropean Parliamentwill be able shortly to start negotiations, allowing us to agree these proposals and enact them as soon as possible”, he said.

The Council adopted rules aimed at boosting transparency to prevent aggressive cross-border tax planning .

tax planning

The directive targets intermediaries such as tax advisors, accountants and lawyers that design and/or promote tax planning schemes. It will require them to report schemes that are potentially aggressive.

"The new rules are a key part of our strategy to combat corporate tax avoidance ", Mr Goranov said. “With greater transparency, risks will be detected at an earlier stage and measures taken to close down loopholes before revenue is lost."

Ministers also agreed to remove the Bahamas and Saint Kitts and Nevis from the EU's list of non-cooperative jurisdictions , in the light of commitments made at a high political level to remedy EU concerns.

list of non-cooperative jurisdictions

Implementation of their commitments will be carefully monitored.

Established in December 2017, the EU's list is contributing to on-going efforts to prevent tax fraud and promote good governance worldwide.

Meeting information

Preparatory documents

Outcome documents

Press releases

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