Table 4.
Clinical postmarketing requirements and commitments investigating modified or new therapeutic indications.
| Study type, No. (%) | Clinical PMRs and PMCs investigating modified or new indications | Clinical PMRs and PMCs investigating modified indications | Clinical PMRs and PMCs investigating new indicationsa | ||
|---|---|---|---|---|---|
| Total | New therapeutic useb | Clinical safety and efficacy datab | |||
| Total | 184 | 123 (66.8) | 61 (33.2) | 40 (65.6) | 21 (34.4) |
| New prospective cohort study, registry, or clinical trial | 103 | 65 (63.1) | 38 (36.9) | 24 (63.2) | 14 (36.8) |
| Complete or submit results from prospective cohort study, registry, or clinical trial | 41 | 30 (73.2) | 11 (26.8) | 6 (54.5) | 5 (45.5) |
| New retrospective observational study | 2 | 1 (50.0) | 1 (50.0) | 1 (100.0) | 0 (0) |
| New analysis or follow-up for cohort study, registry, or clinical trial, or “flexible” requirements | 38 | 27 (71.1) | 11 (28.9) | 9 (81.8) | 2 (18.2) |
PMR: postmarketing requirement; PMC: postmarketing commitment.
Clinical postmarketing requirements and commitments were considered to investigate a new indication when the outlined study was to be conducted in a disease population not related to the original approved indication. This included studies of unapproved therapeutic uses in new disease populations as well as studies intended to generate basic clinical data in a nonspecific disease population (e.g., patients with “solid tumors” or “bacterial infections”).
Values in parentheses reflect percentages of clinical postmarketing requirements and commitments investigating new therapeutic indications.