Cancer
Conditions
Interventions
None listed
Sponsors
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will identify all the immune checkpoint inhibitors for the treatment of any cancers newly approved by the FDA between 2011 and 2014 at the Center for Drug Evaluation and Research Web site, available at http://www.fda.gov/cder/da/da.htm. We will also identify all the other anticancer drugs for the treatment of any cancers newly approved by the FDA between 2011 and 2014, and randomly select 10 drugs among them. For each drug, we will retrieve the FDA Summary Basis for Approval and evaluate the medical and statistical review documents to identify clinical trials submitted by the sponsor.
Exclusion criteria
Exclusion criteria: We will exclude the drugs to treat drug side effects, cancer pain, other conditions, or cancer prevention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of full publication within 2 years after the FDA approval | — |
Countries
Japan
Contacts
Public ContactKenji Omae
Fukushima Medical University Hospital Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)
Outcome results
None listed