Background
Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor’s product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies.

Objectives
To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship.

Search methods
We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files.

Selection criteria
Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions.

Data collection and analysis
Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals).

Main results
Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.32 (95% confidence interval (CI): 1.21 to 1.44), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01).

Authors' conclusions
Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

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Industry sponsorship and research outcome

Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.

/pdf/real-world-evidence-versus-randomized-controlled-trial-1cn7n55gxh.pdf

Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.

Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

/pdf/randomized-controlled-trials-a-matter-of-design-1z2zfzaa0u.pdf

Randomized controlled trials - a matter of design

Background The coronavirus disease 2019 (COVID-19) pandemic has led to a large volume of publications, a barrage of non-reviewed preprints on various professional repositories and a slew of retractions in a short amount of time. Methods We conducted an e-survey using a cloud-based website to gauge the potential sources of trustworthy information and misinformation and analyzed researchers', clinicians', and academics' attitude toward unpublished items, and pre- and post-publication quality checks in this challenging time. Results Among 128 respondents (mean age, 43.2 years; M:F, 1.1:1), 60 (46.9%) were scholarly journal editors and editorial board members. Social media channels were distinguished as the most important sources of information as well as misinformation (81 [63.3%] and 86 [67.2%]). Nearly two in five (62, 48.4%) respondents blamed reviewers, editors, and misinterpretation by readers as additional contributors alongside authors for misinformation. A higher risk of plagiarism was perceived by the majority (70, 58.6%), especially plagiarism of ideas (64.1%) followed by inappropriate paraphrasing (54.7%). Opinion was divided on the utility of preprints for changing practice and changing retraction rates during the pandemic period, and higher rejections were not supported by most (76.6%) while the importance of peer review was agreed upon by a majority (80, 62.5%). More stringent screening by journal editors (61.7%), and facilitating open access plagiarism software (59.4%), including Artificial Intelligence (AI)-based algorithms (43.8%) were among the suggested solutions. Most (74.2%) supported the need to launch a specialist bibliographic database for COVID-19, with information indexed (62.3%), available as open-access (82.8%), after expanding search terms (52.3%) and following due verification by academics (66.4%), and journal editors (52.3%). Conclusion While identifying social media as a potential source of misinformation on COVID-19, and a perceived high risk of plagiarism, more stringent peer review and skilled post-publication promotion are advisable. Journal editors should play a more active role in streamlining publication and promotion of trustworthy information on COVID-19.

/pdf/information-and-misinformation-on-covid-19-a-cross-sectional-4jxpyq7g69.pdf

Information and Misinformation on COVID-19: a Cross-Sectional Survey Study.

A growing body of literature has identified potential problems that can compromise the quality, fairness, and integrity of journal peer review, including inadequate review, inconsistent reviewer reports, reviewer biases, and ethical transgressions by reviewers. We examine the evidence concerning these problems and discuss proposed reforms, including double-blind and open review. Regardless of the outcome of additional research or attempts at reforming the system, it is clear that editors are the linchpin of peer review, since they make decisions that have a significant impact on the process and its outcome. We consider some of the steps editors should take to promote quality, fairness and integrity in different stages of the peer review process and make some recommendations for editorial conduct and decision-making.

Ensuring the Quality, Fairness, and Integrity of Journal Peer Review: A Possible Role of Editors.

Aim
To analyze mistakes and misconduct in multidisciplinary and specialized biomedical journals.

Self-correction in biomedical publications and the scientific impact

This article overviews evidence on common instances of conflict of interest (COI) in research publications from general and specialized fields of biomedicine. Financial COIs are viewed as the most powerful source of bias, which may even distort citation outcomes of sponsored publications. The urge to boost journal citation indicators by stakeholders of science communication is viewed as a new secondary interest, which may compromize the interaction between authors, peer reviewers and editors. Comprehensive policies on disclosure of financial and non-financial COIs in scholarly journals are presented as proxies of their indexing in evidence-based databases, and examples of successful medical journals are discussed in detail. Reports on clinical trials, systematic reviews, meta-analyses and clinical practice guidelines may be unduly influenced by author-pharmaceutical industry relations, but these publications do not always contain explicit disclosures to allow the readers to judge the reliability of the published conclusions and practice-changing recommendations. The article emphasizes the importance of adhering to the guidance on COI from learned associations such as the International Committee of Medical Journal Editors (ICMJE). It also considers joint efforts of authors, peer reviewers and editors as a foundation for appropriately defining and disclosing potential COIs.

Conflicts of interest in biomedical publications: considerations for authors, peer reviewers, and editors.

Unique identifiers of researchers and authors can help all stakeholders of scientific communications improve their workflows. There have been several attempts to establish professional networks of scholars and list their scholarly achievements on digital platforms. Some of these platforms such as Google Scholar, Web of Knowledge and PubMed are searched to pick relevant peer reviewers, assess authors' publication history or choose suitable candidates for research and academic projects. However, each of these hubs has its specific applications, limiting the universal use for permanent tagging of researcher profiles. The Open Researcher and Contributor ID (ORCID) initiative, launched in 2012, is aimed at registering scholarly contributors and averting the persistent ambiguity of recorded author names. The ORCID registry is growing fast and integrating with other ID-generating platforms, thereby increasing the functionality of the integrated systems. ORCID identifiers are increasingly used for selecting peer reviewers and acknowledging various scholarly contributions (e.g., published articles, reviewer comments, conference presentations). The initiative offers unique opportunities for transparent disclosures of author contributions and competing interests and improving ethical standards of research, editing, and publishing.

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Nurbek A. Akazhanov

Papers

Self-correction in biomedical publications and the scientific impact

Conflicts of interest in biomedical publications: considerations for authors, peer reviewers, and editors.

Systematic and open identification of researchers and authors: focus on open researcher and contributor ID.