Rafael Dal-Ré - Academia.edu (original) (raw)

Papers by Rafael Dal-Ré

Research paper thumbnail of Should research misconduct be criminalized?

Research Ethics Review, 2020

Research paper thumbnail of COVID-19 drug research and the cohort multiple randomised controlled trial design

European Respiratory Journal

Research paper thumbnail of Being fair to participants in placebo-controlled COVID-19 vaccine trials

Research paper thumbnail of Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

Research paper thumbnail of Waste in COVID-19 clinical trials conducted in western Europe

European Journal of Internal Medicine, 2020

Research paper thumbnail of The need to implement non-industry COVID-19 clinical trials in non-high-income countries

Journal of Global Health, 2020

Research paper thumbnail of Should research misconduct be criminalized?

Research Ethics, 2020

For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsifica... more For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsification, or plagiarism (FFP)—although other research misbehaviors have been also added in codes of conduct and legislations. A critical issue in deciding whether research misconduct should be subject to criminal law is its definition, because not all behaviors labeled as research misconduct qualifies as serious crime. But assuming that all FFP is fraud and all non-FFP not is far from obvious. In addition, new research misbehaviors have recently been described, such as prolific authorship, and fake peer review, or boosted such as duplication of images. The scientific community has been largely successful in keeping criminal law away from the cases of research misconduct. Alleged cases of research misconduct are usually looked into by committees of scientists usually from the same institution or university of the suspected offender in a process that often lacks transparency. Few countries hav...

Research paper thumbnail of Preregistration and publication of nonregulated intervention trials are here to stay (letter commenting Wallach et al 2018, 93, 88-93)

Journal of Clinical Epidemiology, 2018

Research paper thumbnail of Editors’ and authors’ individual conflicts of interest disclosure and journal transparency. A cross-sectional study of high-impact medical specialty journals

BMJ Open, 2019

ObjectiveTo assess the fulfilment of authors’ and editors’ individual disclosure of potential con... more ObjectiveTo assess the fulfilment of authors’ and editors’ individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties.DesignCross-sectional analysis.Setting and participantsTop-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties.InterventionsObservational analysis.Primary and secondary outcome measuresPercentage of journals requiring disclosure of authors’ and editors’ individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution).ResultsAlthough 99% (129/130) of journals required author’s CoI disclosure, only 12% (16/130) reported individual editors’ potential CoIs. Forty−five per ce...

Research paper thumbnail of Low risk pragmatic trials do not always require participants’ informed consent

Research paper thumbnail of The misleading use of the term pragmatic in pre-licensing medicine trials

European Journal of Clinical Pharmacology, 2019

Research paper thumbnail of Single-dose rufloxacin versus 3-day norfloxacin treatment of uncomplicated cystitis: clinical evaluation and pharmacodynamic considerations

Antimicrobial Agents and Chemotherapy, 1996

The efficacy and safety of rufloxacin (400 mg, single dose) were compared to those of norfloxacin... more The efficacy and safety of rufloxacin (400 mg, single dose) were compared to those of norfloxacin (400 mg twice a day for 3 days) for the treatment of women with uncomplicated cystitis. In addition, urine levels, drug level/MIC ratio, and urine antibacterial activity 72 to 84 h after treatment initiation were determined in a subgroup of patients for pharmacodynamic assessment. A total of 203 women were included and treated in this open, randomized clinical trial; 100 patients received norfloxacin, whereas 103 received rufloxacin. Of these, 156 (74 and 82 patients in the norfloxacin and rufloxacin groups, respectively) were considered bacteriologically evaluable. At the first follow-up visits (3 to 12 days after starting the treatment), bacteriological cure rates were 99 and 94% for norfloxacin and rufloxacin, respectively. Seventy-nine percent (119 of 150) of bacteriologically cured patients attended a long-term follow-up visit (4 to 6 weeks after starting the treatment), where a re...

Research paper thumbnail of Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?

BMC medicine, Apr 3, 2018

Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical... more Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. Explanatory and pragmatic are the extremes of a continuum. This debate article seeks to evaluate and provide recommendation on how to characterize pragmatic RCTs in light of the current landscape of RCTs. It is supported by findings from a PubMed search conducted in August 2017, which retrieved 615 RCTs self-labeled in their titles as "pragmatic" or "naturalistic". We focused on 89 of these trials that assessed medicines (drugs or biologics). 36% of these 89 trials were placebo-controlled, performed before licensing of the medicine, or done in a single-center. In our opinion, such RCTs overtly deviate from usual care and pragmatism. It follows, that ...

Research paper thumbnail of Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

Trials, Jan 23, 2018

Registration of clinical trials is critical for promoting transparency and integrity in medical r... more Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specia...

Research paper thumbnail of Why prudence is needed when interpreting articles reporting clinical trial results in mental health

Research paper thumbnail of Who is willing to participate in low-risk pragmatic clinical trials without consent?

European Journal of Clinical Pharmacology, 2017

Research paper thumbnail of Acceso a los datos individuales anonimizados de los participantes en los ensayos clínicos: el cambio radical de opinión de las revistas médicas de mayor prestigio

Archivos de Bronconeumología, 2017

Cómo citar este artículo: Dal-Ré R. Acceso a los datos individuales anonimizados de los participa... more Cómo citar este artículo: Dal-Ré R. Acceso a los datos individuales anonimizados de los participantes en los ensayos clínicos: el cambio radical de opinión de las revistas médicas de mayor prestigio. Arch Bronconeumol. 2017.

Research paper thumbnail of Comparative effectiveness medicines research cannot assess efficacy

Journal of Clinical Epidemiology, 2017

Research paper thumbnail of International trials in middle-income countries: different local scenarios require different ethical approaches

Journal of the Royal Society of Medicine, Jan 2, 2015

Research paper thumbnail of Prestigio y control de calidad de las revistas médicas

Archivos de Bronconeumología, 2016

Research paper thumbnail of Should research misconduct be criminalized?

Research Ethics Review, 2020

Research paper thumbnail of COVID-19 drug research and the cohort multiple randomised controlled trial design

European Respiratory Journal

Research paper thumbnail of Being fair to participants in placebo-controlled COVID-19 vaccine trials

Research paper thumbnail of Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

Research paper thumbnail of Waste in COVID-19 clinical trials conducted in western Europe

European Journal of Internal Medicine, 2020

Research paper thumbnail of The need to implement non-industry COVID-19 clinical trials in non-high-income countries

Journal of Global Health, 2020

Research paper thumbnail of Should research misconduct be criminalized?

Research Ethics, 2020

For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsifica... more For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsification, or plagiarism (FFP)—although other research misbehaviors have been also added in codes of conduct and legislations. A critical issue in deciding whether research misconduct should be subject to criminal law is its definition, because not all behaviors labeled as research misconduct qualifies as serious crime. But assuming that all FFP is fraud and all non-FFP not is far from obvious. In addition, new research misbehaviors have recently been described, such as prolific authorship, and fake peer review, or boosted such as duplication of images. The scientific community has been largely successful in keeping criminal law away from the cases of research misconduct. Alleged cases of research misconduct are usually looked into by committees of scientists usually from the same institution or university of the suspected offender in a process that often lacks transparency. Few countries hav...

Research paper thumbnail of Preregistration and publication of nonregulated intervention trials are here to stay (letter commenting Wallach et al 2018, 93, 88-93)

Journal of Clinical Epidemiology, 2018

Research paper thumbnail of Editors’ and authors’ individual conflicts of interest disclosure and journal transparency. A cross-sectional study of high-impact medical specialty journals

BMJ Open, 2019

ObjectiveTo assess the fulfilment of authors’ and editors’ individual disclosure of potential con... more ObjectiveTo assess the fulfilment of authors’ and editors’ individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties.DesignCross-sectional analysis.Setting and participantsTop-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties.InterventionsObservational analysis.Primary and secondary outcome measuresPercentage of journals requiring disclosure of authors’ and editors’ individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution).ResultsAlthough 99% (129/130) of journals required author’s CoI disclosure, only 12% (16/130) reported individual editors’ potential CoIs. Forty−five per ce...

Research paper thumbnail of Low risk pragmatic trials do not always require participants’ informed consent

Research paper thumbnail of The misleading use of the term pragmatic in pre-licensing medicine trials

European Journal of Clinical Pharmacology, 2019

Research paper thumbnail of Single-dose rufloxacin versus 3-day norfloxacin treatment of uncomplicated cystitis: clinical evaluation and pharmacodynamic considerations

Antimicrobial Agents and Chemotherapy, 1996

The efficacy and safety of rufloxacin (400 mg, single dose) were compared to those of norfloxacin... more The efficacy and safety of rufloxacin (400 mg, single dose) were compared to those of norfloxacin (400 mg twice a day for 3 days) for the treatment of women with uncomplicated cystitis. In addition, urine levels, drug level/MIC ratio, and urine antibacterial activity 72 to 84 h after treatment initiation were determined in a subgroup of patients for pharmacodynamic assessment. A total of 203 women were included and treated in this open, randomized clinical trial; 100 patients received norfloxacin, whereas 103 received rufloxacin. Of these, 156 (74 and 82 patients in the norfloxacin and rufloxacin groups, respectively) were considered bacteriologically evaluable. At the first follow-up visits (3 to 12 days after starting the treatment), bacteriological cure rates were 99 and 94% for norfloxacin and rufloxacin, respectively. Seventy-nine percent (119 of 150) of bacteriologically cured patients attended a long-term follow-up visit (4 to 6 weeks after starting the treatment), where a re...

Research paper thumbnail of Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?

BMC medicine, Apr 3, 2018

Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical... more Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. Explanatory and pragmatic are the extremes of a continuum. This debate article seeks to evaluate and provide recommendation on how to characterize pragmatic RCTs in light of the current landscape of RCTs. It is supported by findings from a PubMed search conducted in August 2017, which retrieved 615 RCTs self-labeled in their titles as "pragmatic" or "naturalistic". We focused on 89 of these trials that assessed medicines (drugs or biologics). 36% of these 89 trials were placebo-controlled, performed before licensing of the medicine, or done in a single-center. In our opinion, such RCTs overtly deviate from usual care and pragmatism. It follows, that ...

Research paper thumbnail of Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

Trials, Jan 23, 2018

Registration of clinical trials is critical for promoting transparency and integrity in medical r... more Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specia...

Research paper thumbnail of Why prudence is needed when interpreting articles reporting clinical trial results in mental health

Research paper thumbnail of Who is willing to participate in low-risk pragmatic clinical trials without consent?

European Journal of Clinical Pharmacology, 2017

Research paper thumbnail of Acceso a los datos individuales anonimizados de los participantes en los ensayos clínicos: el cambio radical de opinión de las revistas médicas de mayor prestigio

Archivos de Bronconeumología, 2017

Cómo citar este artículo: Dal-Ré R. Acceso a los datos individuales anonimizados de los participa... more Cómo citar este artículo: Dal-Ré R. Acceso a los datos individuales anonimizados de los participantes en los ensayos clínicos: el cambio radical de opinión de las revistas médicas de mayor prestigio. Arch Bronconeumol. 2017.

Research paper thumbnail of Comparative effectiveness medicines research cannot assess efficacy

Journal of Clinical Epidemiology, 2017

Research paper thumbnail of International trials in middle-income countries: different local scenarios require different ethical approaches

Journal of the Royal Society of Medicine, Jan 2, 2015

Research paper thumbnail of Prestigio y control de calidad de las revistas médicas

Archivos de Bronconeumología, 2016