Table 1 Characteristics of trials and ICFs position on publication, data sharing, data ownership, confidentiality, and public benefit
From: Patient consent to publication and data sharing in industry and NIH-funded clinical trials
Total (n = 144) | Industry-funded trials (n = 98) | Publicly funded trials (n = 46) | |
|---|---|---|---|
Characteristics of trials | |||
Year of participant enrollment commencement, median (range) | 2002 (1983–2013) | 2003 (1994–2013) | 1995 (1983–2012) |
Number of participants, median (total) | 460 (224,315) | 319 (35,181) | 914 (189,134) |
ICFs’ position (n, %) | |||
Publication of results | |||
Indicated a commitment to publish | 4 (3) | 1 (1) | 3 (7) |
Indicated a commitment not to publish | 0 (0) | 0 (0) | 0 (0) |
Did not indicate a commitment to publish | 140 (97) | 97 (99) | 43 (93) |
Sharing de-identified data with third-party researchers | |||
Indicated a commitment to share | 6 (4) | 3 (3) | 3 (7) |
Indicated a commitment not to share | 3 (2) | 2 (2) | 1 (2) |
Indicated de-identified data may be shared | 14 (10) | 6 (6) | 8 (17) |
Did not indicate an intention to share | 121 (84) | 87 (89) | 34 (74) |
Will the trial produce knowledge that offers public benefit? | |||
Will produce knowledge | 33 (23) | 15 (15) | 18 (39) |
May produce knowledge | 70 (49) | 51 (52) | 19 (41) |
Unclear statement | 1 (1) | 1 (1) | 0 (0) |
No statement available | 40 (28) | 31 (32) | 9 (20) |
Explicit statement of data ownership | |||
Yes - sponsor | 13 (9)a | 10 (10)a | 3 (7)a |
Yes - other party | 0 (0) | 0 (0) | 0 (0) |
Yes - trialist | 0 (0) | 0 (0) | 0 (0) |
Yes - participants | 0 (0) | 0 (0) | 0 (0) |
Cannot determine or no statement available | 131 (91) | 88 (90) | 43 (93) |
Are patients provided with a general guarantee of confidentiality? | |||
Confidentiality is guaranteed | 137 (95) | 93 (95) | 44 (96) |
Unclear statement | 5 (4) | 4 (4) | 1 (2) |
No statement available | 2 (1) | 1 (1) | 1 (2) |