Table 1.
Description | |
---|---|
Drug-indication pair | |
Biological target | protein on which the drug acts |
Country | country in which the drug is being developed |
Drug-indication development status | current approval status of the drug-indication pair |
Indication | indication for which the drug is under development |
Mechanism of action | mechanism through which the drug produces its pharmacological effect |
Medium | physical composition of the material in which the drug is contained |
Name | name of the drug |
Origin | origin of the active ingredient in the drug |
Prior approval of drug for another indication | approval of the drug for another indication prior to the indication under consideration |
Route | route by which the drug is administered |
Therapeutic class | therapy area for which the drug is in development |
Trial | |
Attribute | distinguishing attribute or feature of the trial, e.g., registration trials, biomarkers, immuno-oncology |
Actual accrual | number of patients enrolled in the trial |
Disease type | disease, disorder, or syndrome studied in the trial |
Duration | duration of the trial |
Exclusion criteria | criteria for excluding a patient from trial consideration |
Gender | gender of the enrolled patients |
Investigator experience | primary investigator's success in developing other drugs prior to the drug-indication pair under consideration |
Location | country in which the trial is conducted |
Number of identified sites | number of sites where the trial is conducted |
Outcome | outcome of the trial |
Patient age | minimum and maximum age of the enrolled patients |
Patient population | general information about the disease condition of the enrolled patients |
Patient segment | disease segmentation by patient subtypes, therapeutic objectives, or disease progression/staging |
Phase 2 end date | year phase 2 ended (end date of the last observed phase 2 trial) |
Primary endpoint | detailed description of primary objective, endpoint, or outcome of the trial; endpoints are classified into four main groups: efficacy, safety/toxicity, health economics and outcomes research, and pharmacokinetics/pharmacodynamics |
Sponsor | financial sponsor of the trial |
Sponsor track record | sponsor's success in developing other drugs prior to the drug-indication pair under consideration |
Sponsor type | sponsor grouped by type |
Status | recruitment status of the trial |
Design | investigative methods used in the trial |
Design keywords | keywords relating to investigative methods used in the trial |
Target accrual | number of patients sought for the trial |
Therapeutic area | therapeutic area of the disease studied in the trial |
See Note S1 for examples of each feature.