Inclusion and exclusion criteria: Difference between revisions
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In a [[clinical trial]], the investigators must specify '''inclusion and exclusion criteria''' for participation in the study. |
In a [[clinical trial]], the investigators must specify '''inclusion and exclusion criteria''' for participation in the study. |
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Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study. Although there is some unclarity concerning the distinction between the two, the [https://www.ich.org/page/efficacy-guidelines ICH E3 guideline] on reporting clinical studies suggests that |
Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study. Although there is some unclarity concerning the distinction between the two, the [https://www.ich.org/page/efficacy-guidelines ICH E3 guideline] on reporting clinical studies suggests that |
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* '''Inclusion criteria''' concern properties of the target population, defining the population to which the study's results should be generalizable. Inclusion criteria may include factors such as type and stage of [[disease]], the subject’s previous treatment history, [[ageing|age]], [[sex]], [[race (human classification)|race]], [[ethnicity]]. |
* '''Inclusion criteria''' concern properties of the target population, defining the population to which the study's results should be generalizable. Inclusion criteria may include factors such as type and stage of [[disease]], the subject’s previous treatment history, [[ageing|age]], [[sex]], [[race (human classification)|race]], [[ethnicity]]. |
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* '''Exclusion criteria''' concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). Exclusion criteria may lead to biases in the study's results. |
* '''Exclusion criteria''' concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). Exclusion criteria may lead to biases in the study's results. |
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'''Poorly Justified Reasons for Exclusion''':<ref name="Van Spall 2007">{{cite journal|last=Van Spall|first=Harriette|title=Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review.|journal=The Journal of the American Medical Association|date=21 March 2007|volume=297|issue=11|pages=1233–40|pmid=17374817|doi=10.1001/jama.297.11.1233}}</ref> |
'''Poorly Justified Reasons for Exclusion''':<ref name="Van Spall 2007">{{cite journal|last=Van Spall|first=Harriette|title=Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review.|journal=The Journal of the American Medical Association|date=21 March 2007|volume=297|issue=11|pages=1233–40|pmid=17374817|doi=10.1001/jama.297.11.1233}}</ref> |
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* Any criteria unless the condition or intervention is specific to the criterion, or the criterion has a direct bearing on condition/intervention/results. |
* Any criteria unless the condition or intervention is specific to the criterion, or the criterion has a direct bearing on condition/intervention/results. |
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'''Strongly Justified Reasons for Exclusion''':<ref name="Van Spall 2007"/> |
'''Strongly Justified Reasons for Exclusion''':<ref name="Van Spall 2007"/> |
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* Unable to provide informed consent |
* Unable to provide informed consent |
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* Placebo or intervention would be harmful |
* Placebo or intervention would be harmful |
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'''Potentially Justified Reasons for Exclusion'''<ref name="Van Spall 2007"/> |
'''Potentially Justified Reasons for Exclusion'''<ref name="Van Spall 2007"/> |
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* Individual may not adhere |
* Individual may not adhere |
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* Individual may not complete follow up |
* Individual may not complete follow up |
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'''Include criteria''': |
'''Include criteria''': |
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* Minimum outcomes: coronary deaths & non-fatal myocardial infarction |
* Minimum outcomes: coronary deaths & non-fatal myocardial infarction |
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* Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension) |
* Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension) |
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'''Exclude criteria''': |
'''Exclude criteria''': |
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* No data |
* No data |
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* Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes) |
* Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes) |
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* Does not measure Framingham variables appropriately |
* Does not measure Framingham variables appropriately |
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* Wrong study design/article format |
* Wrong study design/article format |
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A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population. A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ethnic diversity.<ref>{{Cite journal|last=Pittman|first=Corinne A.|last2=Roura|first2=Raúl|last3=Price|first3=Carrie|last4=Lin|first4=Frank R.|last5=Marrone|first5=Nicole|last6=Nieman|first6=Carrie L.|date=2021-07-01|title=Racial/Ethnic and Sex Representation in US-Based Clinical Trials of Hearing Loss Management in Adults: A Systematic Review|url=https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2779267|journal=JAMA Otolaryngology–Head & Neck Surgery|language=en|volume=147|issue=7|pages=656|doi=10.1001/jamaoto.2021.0550|issn=2168-6181}}</ref> |
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==See also== |
==See also== |
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*[[Drug development]] |
* [[Drug development]] |
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*[[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) |
* [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) |
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*[[European Medicines Agency]] |
* [[European Medicines Agency]] |
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==References== |
==References== |
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== External links == |
== External links == |
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*[http://www.ich.org ICH Website: Guidelines for Clinical Trial Management] |
* [http://www.ich.org ICH Website: Guidelines for Clinical Trial Management] |
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*[https://web.archive.org/web/20130915112715/http://www.fda.gov/ FDA Website] |
* [https://web.archive.org/web/20130915112715/http://www.fda.gov/ FDA Website] |
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*[http://www.biorole.com/ Careers in Clinical Research] |
* [http://www.biorole.com/ Careers in Clinical Research] |
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*[http://www.clinqua.com/ Clinical Research Services] |
* [http://www.clinqua.com/ Clinical Research Services] |
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*[https://web.archive.org/web/20050715035103/http://www.ibpassociation.com/ Clinical Trial Management Companies Listings] |
* [https://web.archive.org/web/20050715035103/http://www.ibpassociation.com/ Clinical Trial Management Companies Listings] |
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[[Category:Clinical research]] |
[[Category:Clinical research]] |
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[[Category: |
[[Category:Clinical trials]] |
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Latest revision as of 01:43, 9 December 2023
In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study.
Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study. Although there is some unclarity concerning the distinction between the two, the ICH E3 guideline on reporting clinical studies suggests that
- Inclusion criteria concern properties of the target population, defining the population to which the study's results should be generalizable. Inclusion criteria may include factors such as type and stage of disease, the subject’s previous treatment history, age, sex, race, ethnicity.
- Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). Exclusion criteria may lead to biases in the study's results.
Exclusion criteria
[edit]Poorly Justified Reasons for Exclusion:[1]
- Any criteria unless the condition or intervention is specific to the criterion, or the criterion has a direct bearing on condition/intervention/results.
Strongly Justified Reasons for Exclusion:[1]
- Unable to provide informed consent
- Placebo or intervention would be harmful
- Lack of equipoise (intervention harmful)
- Effect of intervention difficult to interpret
Potentially Justified Reasons for Exclusion[1]
- Individual may not adhere
- Individual may not complete follow up
- Individuals do not have reliable information
Example of inclusion and exclusion criteria
[edit]Coronary Heart Disease[2]
Include criteria:
- Minimum outcomes: coronary deaths & non-fatal myocardial infarction
- Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension)
- Cohort, nested case-control, cardiovascular trial follow-up study (or systematic review or meta-analysis of these study types) that measures a novel risk factor and estimates its predictive value after adjusting for Framingham variables
Exclude criteria:
- No data
- Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes)
- Does not include minimum outcomes
- Does not measure Framingham variables appropriately
- Wrong study design/article format
A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population. A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ethnic diversity.[3]
See also
[edit]References
[edit]- ^ a b c Van Spall, Harriette (21 March 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". The Journal of the American Medical Association. 297 (11): 1233–40. doi:10.1001/jama.297.11.1233. PMID 17374817.
- ^ Helfand M, Buckley D, Fleming C, et al. (2009). Screening for Intermediate Risk Factors for Coronary Heart Disease. Rockville (MD): Agency for Healthcare Research and Quality (US).
- ^ Pittman, Corinne A.; Roura, Raúl; Price, Carrie; Lin, Frank R.; Marrone, Nicole; Nieman, Carrie L. (2021-07-01). "Racial/Ethnic and Sex Representation in US-Based Clinical Trials of Hearing Loss Management in Adults: A Systematic Review". JAMA Otolaryngology–Head & Neck Surgery. 147 (7): 656. doi:10.1001/jamaoto.2021.0550. ISSN 2168-6181.