Table 2.
Patient Encounters by Variable of Interest and Group Category
| Variable | No. (%) of Trials and Staff With Patient Encounters by Group Category | ||||
|---|---|---|---|---|---|
| Group 1 (n = 415 trials; n = 63 staff) | Group 2 (n = 451 trials; n = 147 staff) | Group 3 (n = 180 trials; n = 32 staff) | Group 4 (n = 272 trials; n = 55 staff) | Group 5 (n = 139 trials; n = 26 staff) | |
| Sponsor type | |||||
| NIH/NCI cooperative group/research base | 350 (84) | 313 (69) | 115 (64) | 69 (25) | 84 (60) |
| Industry | 38 (9) | 84 (19) | 47 (26) | 162 (60) | 40 (29) |
| Academic | 6 (1) | 28 (6) | 9 (5) | 5 (2) | 4 (3) |
| Other | 21 (5) | 26 (6) | 9 (5) | 36 (13) | 11 (8) |
| Type of trial | |||||
| Treatment | 345 (83) | 379 (84) | 145 (81) | 237 (87) | 110 (79) |
| Cancer control | 45 (11) | 56 (12) | 19 (11) | 16 (6) | 15 (11) |
| Correlative science | 13 (3) | 2 | 4 (2) | 2 (1) | 3 (2) |
| Observational/registry | 12 (3) | 12 (3) | 12 (7) | 16 (6) | 11 (8) |
| Prevention | 0 | 1 | 0 | 1 | 0 |
| Other | 0 | 1 | 0 | 0 | 0 |
| Type of research staff* | |||||
| Clinical research associate | 35 (56) | 40 (27) | 5 (16) | 9 (16) | 2 (8) |
| Research coordinator | 1 (2) | 37 (25) | 5 (16) | 4 (7) | 6 (23) |
| Research nurse | 24 (38) | 53 (36) | 22 (69) | 40 (73) | 18 (69) |
| Administrator/manager | 0 | 1 (1) | 0 | 2 (4) | 0 |
| Team | 3 (5) | 16 (11) | 0 | 0 | 0 |
NOTE. Group 1, CCOP/MB-CCOP with seven or fewer FTEs (n = 13 research programs); group 2, CCOP/MB-CCOP with more than 7 FTE (n = 10 research programs); group 3, community hospital/NCCCP (n = 8 research programs); group 4, private practice, not hospital based/private research network (n = 12 research programs); group 5 = private practice, hospital based (n = 7 research programs).
Abbreviations: CCOP, Community Clinical Oncology Program; MBCCOP, Minority-Based CCOP; NCCCP, NCI Community Cancer Center Program; NCI, National Cancer Institute; NIH, National Institutes of Health.
Clinical research associate (non-nurse): unlicensed, with or without college degree, and responsible for collection, submission, and monitoring of clinical trial–associated data, and so on. May be involved in recruitment and screening process but has minimal patient contact. Research coordinator: responsible for protocol evaluation and feasibility including budget evaluation and trial preparation and planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms, and patient recruitment. May also have responsibilities pertaining to coordination and management of research staff. Research nurse: licensed registered nurse responsible for assessing patients for clinical trials; enrolling and monitoring patients (assessing adverse events, and so on); consenting process, communication with physician investigator(s), patient(s), and family/friends; verifying data collected is accurate, and so on. Administrator/manager: responsible for research staff and overall research program.