- Email: [email protected]
Registration of clinical trials for publication
Accepted Manuscript Registration of clinical trials for publication Chad Cook, Gwendolen Jull, Ann Moore PII:
S1356-689X(14)00077-0
DOI:
10.1016/j.math.2014.04.012
Reference:
YMATH 1559
To appear in:
Manual Therapy
Please cite this article as: Cook C, Jull G, Moore A, Registration of clinical trials for publication, Manual Therapy (2014), doi: 10.1016/j.math.2014.04.012. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
EDITORIAL Registration of clinical trials for publication
RI PT
A recent joint editorial from the majority of physical medicine and rehabilitation journal editors (Costa et al. 2013) outlined the benefits of clinical trials registration and the potential improvements in manuscript reporting in subsequent publications. The editors of Manual
SC
Therapy supported this initiative, having adopted time oriented, stepwise procedures for
mandating trial registration. As stated on the Manual Therapy website, ‘clinical trials that
M AN U
commence after 1st June 2013 must be registered to be considered for publication in Manual Therapy. Authors will be asked to state the trial registration number during the online submission process as well as at the end of the manuscript file. From January 2014 Manual Therapy will not be able to accept any unregistered Clinical Trial papers. By 2015 the journal will not be able to
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publish any clinical trials that are unregistered prior to recruitment of the first participant.’ Our goal in this editorial is define the boundaries of a “clinical trial” for our authorship and readership. We like nearly all biomedical journals, have adopted the criteria outlined by the
EP
International Committee of Medical Journal Editors (ICMJE), which in June 2007 adopted the WHO's definition of clinical trial.
AC C
As indicated on the ICJME website: The ICMJE defines a clinical trial as any research project that prospectively
assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical
ACCEPTED MANUSCRIPT
procedures, devices, behavioural treatments, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic
RI PT
measures and adverse events. The ICMJE does not define the timing of first patient
enrolment, but best practice dictates registration by the time of first patient consent. In short, a clinical trial is defined as any research study that prospectively assigns human
SC
participants or groups of humans (asymptomatic or symptomatic) to one or more intervention that is designed to influence elements of health (e.g., strength, range of motion, etc.) to evaluate
M AN U
the effects on outcomes commonly associated with health status (e.g., disability, pain, quality of life, etc.). Thus the scope of study designs requiring registration ranges from laboratory research investigating the mechanisms of a certain intervention through to the more familiar clinical trials. Clinical trials of interventions on patients of any design require registration be they comparative
TE D
studies, case-control studies, pseudo-randomised controlled trial or the gold standard randomised controlled trial. The ICMJE also encourages registration of research with non-trial designs but does not require it in selective cases. For clarity, we provide examples of three study designs that
registry.
EP
are not formal randomized clinical trials to illustrate studies that do and do not require trial
AC C
Example Number One:
Researchers from a European University were interested in following the health related
outcomes of 16 children diagnosed with Pompeii’s disease. The researchers routinely evaluated health related outcomes but supplied no formal intervention and were purely interested in measuring the health outcomes changes associated with the natural history of the disease. If a manuscript was written with respect to this design would this require clinical trials registration?
ACCEPTED MANUSCRIPT
Answer: The study is an observational design in which no definitive intervention is applied to evaluate its influence on health related outcomes. The study would not require clinical trials registration because there are no prospectively assigned interventions that could influence
RI PT
health related outcomes. Example Number Two:
Researchers from a health institution in Canada were optimistic that a specific, new
SC
manual therapy procedure was associated with quicker returns to occupation in subjects with chronic whiplash associated disorder. After a series of applications with 11 individuals and after
M AN U
recognition that the outcomes appeared to be promising, the researchers decided to outline their findings in a case series; using documentation to report findings specific to each individual. There was no comparative control. Would this manuscript require clinical trial registration? Answer: This study is a case series and case series cannot imply cause and effect. Further,
TE D
clinical trials registration is required for prospective assignment of one or more groups and this manuscript outlines retrospective findings. Consequently, this paper would not require clinical trials registration. If the authors were interested in prospectively evaluating the outcomes
register their study.
EP
associated with the specific, new manual therapy approach they would have been required to
AC C
Example Number Three:
A research team from South America is interested in evaluating range of motion benefits
and adverse reactions from three forms of stretching procedures (aggressive, moderate, and light) in a population of asymptomatic individuals. Of particular interest in the adverse reactions of those in the aggressive stretching groups in comparison to the other two comparative groups that involved forces most commonly associated with clinical practice. The study is a three arm
ACCEPTED MANUSCRIPT
randomized trial but does not involve symptomatic subjects. Would this study require clinical trials registration? Answer: Yes, this study would require clinical trials registration. Although the population
of adverse events advocates the registration of the trial.
RI PT
is symptomatic and although range of motion is a dedicated outcomes measure, the assessment
There are several trial registries with regional biases where a researcher may register their
SC
interventional study. These include:
www.clinicaltrials.gov www.ISRCTN.org www.umin.ac.jp/ctr/index/htm www.trialregister.nl
TE D
https://eudract.ema.europa.eu/
M AN U
www.anzctr.org.au
We hope this editorial provides context and appropriate examples of those study designs
EP
that require clinical trials registration. As suggested previously, clinical trials registration reduces the risks of publication bias and selective reporting. For more information, the ICMJE provides
AC C
answers to frequently asked questions on their website. FAQ’s http://www.icmje.org/abouticmje/faqs/clinical-trials-registration/. We also encourage potential authors to contact the editorial staff of Manual Therapy if they have questions associated with their trial.
Reference
ACCEPTED MANUSCRIPT
Costa LO, Christine Lin CW, Grossi DB, Mancini MC, Swisher AK, Cook C, Vaughn D, Elkins MR, Sheikh U, Moore A, Jull G, Craik RL, Maher CG, de Jesus Guirro RR, Marques AP, Harms M, Brooks D, Simoneau GG, Strupstad JH. Clinical trial registration in physiotherapy journals:
RI PT
Recommendations from the International Society of Physiotherapy Journal Editors. Manual Therapy 18 (1): 1–3.
SC
Chad Cook, Associate Editor
M AN U
Walsh University, North Canton, OH, USA
Gwendolen Jull, Editor
Division of Physiotherapy, School of Health and Rehabilitation Sciences,
TE D
The University of Queensland, 4072, Australia
Ann Moore, Editor
University of Brighton, Clinical Research Centre for Health Professions,
AC C
EP
Aldro Building, 49, Darley Road, Eastbourne BN20 7UR, United Kingdom
Address for correspondence Professor Chad Cook E-mail address: [email protected]
S1356-689X(14)00077-0
DOI:
10.1016/j.math.2014.04.012
Reference:
YMATH 1559
To appear in:
Manual Therapy
Please cite this article as: Cook C, Jull G, Moore A, Registration of clinical trials for publication, Manual Therapy (2014), doi: 10.1016/j.math.2014.04.012. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
EDITORIAL Registration of clinical trials for publication
RI PT
A recent joint editorial from the majority of physical medicine and rehabilitation journal editors (Costa et al. 2013) outlined the benefits of clinical trials registration and the potential improvements in manuscript reporting in subsequent publications. The editors of Manual
SC
Therapy supported this initiative, having adopted time oriented, stepwise procedures for
mandating trial registration. As stated on the Manual Therapy website, ‘clinical trials that
M AN U
commence after 1st June 2013 must be registered to be considered for publication in Manual Therapy. Authors will be asked to state the trial registration number during the online submission process as well as at the end of the manuscript file. From January 2014 Manual Therapy will not be able to accept any unregistered Clinical Trial papers. By 2015 the journal will not be able to
TE D
publish any clinical trials that are unregistered prior to recruitment of the first participant.’ Our goal in this editorial is define the boundaries of a “clinical trial” for our authorship and readership. We like nearly all biomedical journals, have adopted the criteria outlined by the
EP
International Committee of Medical Journal Editors (ICMJE), which in June 2007 adopted the WHO's definition of clinical trial.
AC C
As indicated on the ICJME website: The ICMJE defines a clinical trial as any research project that prospectively
assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical
ACCEPTED MANUSCRIPT
procedures, devices, behavioural treatments, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic
RI PT
measures and adverse events. The ICMJE does not define the timing of first patient
enrolment, but best practice dictates registration by the time of first patient consent. In short, a clinical trial is defined as any research study that prospectively assigns human
SC
participants or groups of humans (asymptomatic or symptomatic) to one or more intervention that is designed to influence elements of health (e.g., strength, range of motion, etc.) to evaluate
M AN U
the effects on outcomes commonly associated with health status (e.g., disability, pain, quality of life, etc.). Thus the scope of study designs requiring registration ranges from laboratory research investigating the mechanisms of a certain intervention through to the more familiar clinical trials. Clinical trials of interventions on patients of any design require registration be they comparative
TE D
studies, case-control studies, pseudo-randomised controlled trial or the gold standard randomised controlled trial. The ICMJE also encourages registration of research with non-trial designs but does not require it in selective cases. For clarity, we provide examples of three study designs that
registry.
EP
are not formal randomized clinical trials to illustrate studies that do and do not require trial
AC C
Example Number One:
Researchers from a European University were interested in following the health related
outcomes of 16 children diagnosed with Pompeii’s disease. The researchers routinely evaluated health related outcomes but supplied no formal intervention and were purely interested in measuring the health outcomes changes associated with the natural history of the disease. If a manuscript was written with respect to this design would this require clinical trials registration?
ACCEPTED MANUSCRIPT
Answer: The study is an observational design in which no definitive intervention is applied to evaluate its influence on health related outcomes. The study would not require clinical trials registration because there are no prospectively assigned interventions that could influence
RI PT
health related outcomes. Example Number Two:
Researchers from a health institution in Canada were optimistic that a specific, new
SC
manual therapy procedure was associated with quicker returns to occupation in subjects with chronic whiplash associated disorder. After a series of applications with 11 individuals and after
M AN U
recognition that the outcomes appeared to be promising, the researchers decided to outline their findings in a case series; using documentation to report findings specific to each individual. There was no comparative control. Would this manuscript require clinical trial registration? Answer: This study is a case series and case series cannot imply cause and effect. Further,
TE D
clinical trials registration is required for prospective assignment of one or more groups and this manuscript outlines retrospective findings. Consequently, this paper would not require clinical trials registration. If the authors were interested in prospectively evaluating the outcomes
register their study.
EP
associated with the specific, new manual therapy approach they would have been required to
AC C
Example Number Three:
A research team from South America is interested in evaluating range of motion benefits
and adverse reactions from three forms of stretching procedures (aggressive, moderate, and light) in a population of asymptomatic individuals. Of particular interest in the adverse reactions of those in the aggressive stretching groups in comparison to the other two comparative groups that involved forces most commonly associated with clinical practice. The study is a three arm
ACCEPTED MANUSCRIPT
randomized trial but does not involve symptomatic subjects. Would this study require clinical trials registration? Answer: Yes, this study would require clinical trials registration. Although the population
of adverse events advocates the registration of the trial.
RI PT
is symptomatic and although range of motion is a dedicated outcomes measure, the assessment
There are several trial registries with regional biases where a researcher may register their
SC
interventional study. These include:
www.clinicaltrials.gov www.ISRCTN.org www.umin.ac.jp/ctr/index/htm www.trialregister.nl
TE D
https://eudract.ema.europa.eu/
M AN U
www.anzctr.org.au
We hope this editorial provides context and appropriate examples of those study designs
EP
that require clinical trials registration. As suggested previously, clinical trials registration reduces the risks of publication bias and selective reporting. For more information, the ICMJE provides
AC C
answers to frequently asked questions on their website. FAQ’s http://www.icmje.org/abouticmje/faqs/clinical-trials-registration/. We also encourage potential authors to contact the editorial staff of Manual Therapy if they have questions associated with their trial.
Reference
ACCEPTED MANUSCRIPT
Costa LO, Christine Lin CW, Grossi DB, Mancini MC, Swisher AK, Cook C, Vaughn D, Elkins MR, Sheikh U, Moore A, Jull G, Craik RL, Maher CG, de Jesus Guirro RR, Marques AP, Harms M, Brooks D, Simoneau GG, Strupstad JH. Clinical trial registration in physiotherapy journals:
RI PT
Recommendations from the International Society of Physiotherapy Journal Editors. Manual Therapy 18 (1): 1–3.
SC
Chad Cook, Associate Editor
M AN U
Walsh University, North Canton, OH, USA
Gwendolen Jull, Editor
Division of Physiotherapy, School of Health and Rehabilitation Sciences,
TE D
The University of Queensland, 4072, Australia
Ann Moore, Editor
University of Brighton, Clinical Research Centre for Health Professions,
AC C
EP
Aldro Building, 49, Darley Road, Eastbourne BN20 7UR, United Kingdom
Address for correspondence Professor Chad Cook E-mail address: [email protected]