Enum: ResearchPhaseEnum
Permissible Values
Value |
Meaning |
Description |
pre_clinical_research_phase |
None |
Biolink 'pre_clinical_research' is the union of both the FDA discovery and development phase and FDA preclinical research phase . Discovery involves researchers finding new possibilities for medication through testing molecular compounds, noting unexpected effects from existing treatments, or the creation of new technology that allows novel ways of targeting medical products to sites in the body. Drug development occurs after researchers identify potential compounds for experiments Preclinical Research Phase. Once researchers have examined the possibilities a new drug may contain, they must do preliminary research to determine its potential for harm (toxicity). This is categorized as preclinical research and can be one of two types: in vitro or in vivo. |
clinical_trial_phase |
None |
Clinical research involves trials of the drug on people, and it is one of the most involved stages in the drug development and approval process. Clinical trials must answer specific questions and follow a protocol determined by the drug researcher or manufacturer. |
clinical_trial_phase_1 |
None |
In the FDA Clinical Trial Phase, the Clinical Trial Phase 1 involves 20 – 100 study participants and lasts several months. This phase is used to determine the safety and dosage of the drug, and about 70% of these drugs move on to the next clinical research phase. |
clinical_trial_phase_2 |
None |
In the FDA Clinical Trial Phase, the Clinical Trial Phase 2 involves up to several hundred people, who must have the disease or condition the drug supposes to treat. This phase can last from a few months to two years, and its purpose is to monitor the efficacy of the drug, as well as note side effects that may occur. |
clinical_trial_phase_3 |
None |
In the FDA Clinical Trial Phase, the Clinical Trial Phase 3 involves 300 – 3000 volunteers and can last up to four years. It is used to continue monitoring the efficacy of the drug, as well as exploring any longer-term adverse reactions. |
clinical_trial_phase_4 |
None |
In the FDA Clinical Trial Phase, the Clinical Trial Phase 4 involves several thousands of volunteers who have the disease or condition and continues to monitor safety and efficacy. If a drug passes this phase, it goes on to FDA review. |
not_provided |
None |
None |
Slots constrained by this enum
LinkML Source
name: ResearchPhaseEnum
from_schema: https://w3id.org/biolink/biolink-model
permissible_values:
pre_clinical_research_phase:
text: pre_clinical_research_phase
description: 'Biolink ''pre_clinical_research'' is the union of both the `FDA
discovery and development phase` and `FDA preclinical research phase`. Discovery
involves researchers finding new possibilities for medication through testing
molecular compounds, noting unexpected effects from existing treatments, or
the creation of new technology that allows novel ways of targeting medical products
to sites in the body. Drug development occurs after researchers identify potential
compounds for experiments Preclinical Research Phase. Once researchers have
examined the possibilities a new drug may contain, they must do preliminary
research to determine its potential for harm (toxicity). This is categorized
as preclinical research and can be one of two types: in vitro or in vivo.'
notes:
- DrugBank calls this 'experimental'.
clinical_trial_phase:
text: clinical_trial_phase
description: Clinical research involves trials of the drug on people, and it is
one of the most involved stages in the drug development and approval process.
Clinical trials must answer specific questions and follow a protocol determined
by the drug researcher or manufacturer.
clinical_trial_phase_1:
text: clinical_trial_phase_1
description: In the FDA Clinical Trial Phase, the Clinical Trial Phase 1 involves
20 – 100 study participants and lasts several months. This phase is used to
determine the safety and dosage of the drug, and about 70% of these drugs move
on to the next clinical research phase.
is_a: clinical_trial_phase
clinical_trial_phase_2:
text: clinical_trial_phase_2
description: In the FDA Clinical Trial Phase, the Clinical Trial Phase 2 involves
up to several hundred people, who must have the disease or condition the drug
supposes to treat. This phase can last from a few months to two years, and its
purpose is to monitor the efficacy of the drug, as well as note side effects
that may occur.
is_a: clinical_trial_phase
clinical_trial_phase_3:
text: clinical_trial_phase_3
description: In the FDA Clinical Trial Phase, the Clinical Trial Phase 3 involves
300 – 3000 volunteers and can last up to four years. It is used to continue
monitoring the efficacy of the drug, as well as exploring any longer-term adverse
reactions.
is_a: clinical_trial_phase
clinical_trial_phase_4:
text: clinical_trial_phase_4
description: In the FDA Clinical Trial Phase, the Clinical Trial Phase 4 involves
several thousands of volunteers who have the disease or condition and continues
to monitor safety and efficacy. If a drug passes this phase, it goes on to FDA
review.
is_a: clinical_trial_phase
not_provided:
text: not_provided