Table 1.
Features of the included RCTs
| Features | n = 393 | Features | n = 393 |
|---|---|---|---|
|
Protocol duration, years (median (Q1, Q3) [range]) |
5 (3, 6) [1–20] |
Number of sites
(median (Q1, Q3) [range]) |
58 (22, 133) [1–1459] |
|
Target accrual
(median (Q1, Q3) [range]) |
10 (7, 25) [1–2600] |
Target enrollment
(median (Q1, Q3) [range]) |
15 (10, 40) [1–6000] |
|
Accrual to date
(median (Q1, Q3) [range]) |
4 (2, 10) [0–2013] |
Enrolled to date
(median (Q1, Q3) [range]) |
6 (3, 15) [0–5612] |
|
Accrual percentage
(mean (SD)) |
46.7 (32.0) |
Number of modifications
(median (Q1, Q3) [range]) |
1 (0, 2) [0–8] |
| Study Phase# (n (%)) | Funding type* (n (%)) | ||
| Phase 1 | 19 (4.8) | Federal/State/Local Government | 53 (13.5) |
| Phase 2 | 138 (35.1) | Industry | 264 (67.2) |
| Phase 3 | 206 (52.4) | Foundation/Private | 8 (2) |
| Phase 4 | 13 (3.3) | Internal | 50 (12.7) |
| Not applicable | 45 (11.5) | Unknown | 23 (5.9) |
| Multicenter Research (n (%)) | Procedures Included in Study* (n (%)) | ||
| Yes | 379 (96.4) | Recording Subjects | 42 (10.7) |
| No | 14 (3.6) | Behavioral Intervention | 8 (2) |
| Biologic Specimens | 361 (91.9) | ||
| Resource Utilization* (n (%)) | Cancer Research | 139 (35.4) | |
| Clinical Research Resource | 107 (27.2) | Drug or Biologic Agent | 344 (87.5) |
| CCPH | 1 (0.3) | Genetics Research | 173 (44) |
| None | 190 (48.3) | Imaging or Radiation | 241 (61.3) |
| Medical Device | 59 (15) | ||
| Involvement & Targeted Populations* (n (%)) | Surgical Procedures | 20 (5.1) | |
| Involves Subject Screening | 382 (97.2) | ||
| Involves Sub-Studies | 61 (15.5) | Qualitative and Evaluation Methods* (n (%)) | |
| Involves Compensation | 206 (52.4) | Survey, Interview, Questionnaires¤ | 277 (70.5) |
| Minors/Children | 51 (13) | Systematic Observation | 2 (0.5) |
| Pregnant Women | 8 (2) | Cognitive Test | 51 (13) |
| Lacking Capacity for Consent | 52 (13.2) | Education Test | 1 (0.3) |
| CU/NYPH Employees | 8 (2) | Noninvasive Measure¤ | 240 (61.1) |
| Economically Disadvantaged | 36 (9.2) | Taste Test | 5 (1.3) |
| Educationally Disadvantaged | 25 (6.4) | ||
| Non-English Speaking | 216 (55) | Recruitment Methods Used* (n (%)) | |
| Other Vulnerable Population‡ | 12 (3.1) | Recruitment methods not involved | 26 (6.6) |
| No Vulnerable Population† | 140 (35.6) | Person-to-Person | 365 (92.9) |
| Direct Telephone Calls | 32 (8.1) | ||
| Written Consent Obtained*(n (%)) | Radio Advertisements | 6 (1.5) | |
| Consent Obtained | 388 (98.7) | Newspaper Advertisements | 6 (1.5) |
| Written Consent Waived | 19 (4.8) | Direct Mail Invitation | 11 (2.8) |
| Consent Waived per 45CFR46116 | 3 (0.8) | Website | 212 (53.9) |
| Consent Waived per 21CFR5024 | 2 (0.5) | Email Invitation | 23 (5.9) |
| Consent Exempt | 3 (0.8) | Television Advertisements | 5 (1.3) |
| Newsletter Advertisements | 6 (1.5) | ||
| Written Consent Language (n (%)) | Posting on ResearchMatch.org | 15 (3.8) | |
| Non-English language expected | 234 (59.5) | ||
| Non-English language not expected | 158 (40.2) | ||
| Consent Language Unknown | 1 (0.3) | ||
CCPH = columbia community partnership for health; CU = columbia university; NYPH = New York presbyterian hospital; Q1 = first quartile; Q3 = third quartile; SD = standard deviation.
One RCT may have multiple answers.
Studies may have multiple phases (e.g., Phase 1/2).
Other unspecified vulnerable population other than Minors/Children, Pregnant Women, Lacking Capacity for Consent, CU/NYPH Employees, Economically Disadvantaged, Educationally Disadvantaged, and Non-English Speaking individuals.
Studies where the expected enrollment does not specifically include, or aim to recruit from, any recognized vulnerable groups. It does not necessarily imply that these groups are excluded from participation by the eligibility criteria, but rather that they are not the targeted or anticipated demographic for recruitment.
Distinctions between the different types of data collection methods used. Noninvasive measures include the gathering of physiological parameters without the use of invasive procedures, such as monitoring heart rate, measuring blood pressure, or checking temperature. Conversely, ’survey, interview, and questionnaires’ referred to tools utilized to acquire information regarding the participants’ feelings, thoughts, behaviors, or experiences through self-reporting methods. While both categories could be considered ‘noninvasive’ in the broad sense, these were separated due to the distinct types of data each method collects.