The publication and subsequent retraction in June, 2020, of the article 'Hydroxychloroquine (HCQ) or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis', based on an alleged dataset associated with Surgisphere, prompted The Lancet's peer-review processes to identify ways of further reducing risks of research and publication misconduct.

The retraction episode had raised several pertinent issues in the field of medical research.

As a result of this review, with immediate effect, changes have been made to the declarations seeked from authors, the data sharing statements required for published research papers, and the peer-review process for similar papers based on large datasets or real-world data.

Changes to the signed declarations by authors in the author statements form will require that more than one author has directly accessed and verified the data reported in the manuscript. We will require that the authors who have accessed and verified underlying data are named in the contributors' statement.

For research articles that are the result of an academic and commercial partnership, one of the authors named as having accessed and verified data must be from the academic team. In addition, all authors will be asked to sign the author statements form to confirm they had full access to the data reported in their Article, and accept responsibility for submitting the Article for publication.

All Lancet journals will now introduce additional peer-review requirements for papers based on large, real-world datasets. Editors will ensure that at least one peer reviewer is knowledgable about the details of the dataset being reported and can understand and comment on its strengths and limitations in relation to the research question being addressed