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==2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure==
{| class="wikitable"
 
==Class I==
 
{|class="wikitable" style="width:80%"
|-
|-
| colspan="1" style="text-align:center; background: LightGreen"|[[ACC AHA guidelines classification scheme#Classification of Recommendations|Class I]]
! colspan="5" style="background-color: #CCEEEE;" |Summary of clinical trial phases
|-
|-
| bgcolor="LightGreen"|
!Phase
'''1.'''
!Primary goal
.
!Dose
([[ACC AHA guidelines classification scheme#Level of Evidence|Class I, Level of Evidence: A]])
!Patient monitor
!Typical number of participants
|-
|-
|}
|Preclinical
 
|Testing of drug in non-human subjects, to gather [[efficacy]], [[toxicity]] and [[pharmacokinetic]] information
==Class III (No Benefit)==
|unrestricted
 
|scientific researcher
{|class="wikitable" style="width:80%"
|not applicable (''[[in vitro]]'' and ''[[in vivo]]'' only)
|-
|-
| colspan="1" style="text-align:center; background: LightCoral"|[[ACC AHA guidelines classification scheme#Classification of Recommendations|Class III (No Benefit)]]
|Phase 0
|[[Pharmacokinetics]]; particularly, oral bioavailability and half-life of the drug
|very small, subtherapeutic
|clinical researcher 
|10 people
|-
|-
| bgcolor="LightCoral"|
|Phase I
'''1.'''
|Testing of drug on healthy volunteers for [[dose-ranging]]
.
|often subtherapeutic, but with ascending doses
([[ACC AHA guidelines classification scheme#Level of Evidence|Class III, Level of Evidence: A]])
|clinical researcher
|20–100 normal healthy volunteers (or for cancer drugs, cancer patients)
|-
|-
|}
|Phase II
 
|Testing of drug on patients to assess efficacy and side effects
==Class III (Harm)==
|therapeutic dose
 
|clinical researcher
{|class="wikitable" style="width:80%"
|100–300 patients with specific diseases
|-
|-
| colspan="1" style="text-align:center; background: LightCoral"|[[ACC AHA guidelines classification scheme#Classification of Recommendations|Class III (Harm)]]
|Phase III
|-
|Testing of drug on patients to assess efficacy, effectiveness and safety
| bgcolor="LightCoral"|
|therapeutic dose
'''1.'''
|clinical researcher and personal physician
.
|300–3,000 patients with specific diseases
([[ACC AHA guidelines classification scheme#Level of Evidence|Class III, Level of Evidence: A]])
|-
|}
 
==Class IIa==
 
{|class="wikitable" style="width:80%"
|-
| colspan="1" style="text-align:center; background: LemonChiffon"|[[ACC AHA guidelines classification scheme#Classification of Recommendations|Class IIa]]
|-
| bgcolor="LemonChiffon"|
'''1.'''
.
([[ACC AHA guidelines classification scheme#Level of Evidence|Class IIa, Level of Evidence: A]])
|-
|}
 
==Class IIb==
 
{|class="wikitable" style="width:80%"
|-
| colspan="1" style="text-align:center; background: LemonChiffon"|[[ACC AHA guidelines classification scheme#Classification of Recommendations|Class IIb]]
|-
| bgcolor="LemonChiffon"|
'''1.'''
.
([[ACC AHA guidelines classification scheme#Level of Evidence|Class IIb, Level of Evidence: A]])
|-
|-
|Phase IV
|[[Postmarketing surveillance]] – watching drug use in public
|therapeutic dose
|personal physician
|anyone seeking treatment from their physician
|}
|}

Revision as of 03:35, 24 October 2017


Summary of clinical trial phases
Phase Primary goal Dose Patient monitor Typical number of participants
Preclinical Testing of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information unrestricted scientific researcher not applicable (in vitro and in vivo only)
Phase 0 Pharmacokinetics; particularly, oral bioavailability and half-life of the drug very small, subtherapeutic clinical researcher  10 people
Phase I Testing of drug on healthy volunteers for dose-ranging often subtherapeutic, but with ascending doses clinical researcher 20–100 normal healthy volunteers (or for cancer drugs, cancer patients)
Phase II Testing of drug on patients to assess efficacy and side effects therapeutic dose clinical researcher 100–300 patients with specific diseases
Phase III Testing of drug on patients to assess efficacy, effectiveness and safety therapeutic dose clinical researcher and personal physician 300–3,000 patients with specific diseases
Phase IV Postmarketing surveillance – watching drug use in public therapeutic dose personal physician anyone seeking treatment from their physician
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