Table 1 Surveys looking globally at trial monitoring practices
Year of survey | Reference | Sampling frame | Number of people to whom survey was sent (n) and survey response rate | Number of people (n) who answered the question related to interim data or results sharing | Results | Interpretation of their results |
|---|---|---|---|---|---|---|
1993 | [12] | Trialists from the NIH for the USA | n = 12 Response rate: 100% | n = 12 | Quantitative results are unclear Only qualitatively reported as: “DMC reports are confidential, with access to DMC members and selected institute staff.” | Respondents from the NIH support that DSMB reports are to be confidential and privy only to DSMB members with access also granted to selected NIH US staff. |
1993 | [11] | Directors of the statistical centres from 12 cancer cooperative groups sponsored by the NCI in the USA | n = 13 Response rate: 100% | First question about reporting interim results by treatment regimen: n = 9 Second question related to non-DSMB member access to interim data reports: n = 10 | First question: 0% of the respondents (0) indicated that NCI groups provided unmasked outcome reports to the participants. Second question: 70% of the respondents (7) indicate interim data reports are not accessed by non-DSMB members | The majority of respondents indicate interim data reports are not accessed by non-DSMB members. |
2000 | [5] | Trialists from completed trials | n = 45 Response rate: 62% | Unclear | Quantitative results are unclear Only qualitatively reported as: “Views on sharing the interim information with other DMCs were consistent; the investigators were not enthusiastic about the DMC consulting others” | Based on the qualitative reporting it appears that investigators are not supportive of DSMB consulting others outside of the DSMB. |
2002 | [5] | Trialists from ongoing trials | n = 40 Response rate: 80% | n = 20 | 50% of respondents (10) agree with the DSMB sharing interim data or results, if it is necessary, with non-DSMB members • Many of these 10 respondents said it should be done if there was a safety concern • 1 respondent from this group felt it was acceptable to share safety but not efficacy data • 2 respondents from this group felt that the SC should make the decision if the DSMB were to share data or results on an individual basis 30% of respondents (6) have no provision for the DSMB sharing data or results with non-DSMB members • 1 respondent from this group indicated that the need to share should be dealt with by the SC on an ad hoc basis 20% of respondents (4) disagree with the DSMB interim data or results sharing with non-DSMB members • 1 respondent from this group indicated that the DSMB can seek external advice but not share interim data or results | Variation and disagreement in the responses about whether the DSMB should share interim data or results with non-DSMB members. The largest group of respondents (50%) agree with DSMBs sharing interim data or results with non-DSMB members when it is necessary, particularly for safety. |
2001/2002 | [5] | Review of DSMB policies of major funders of trials, regulatory agencies and other relevant organisations related to trial research | n = 25 Response rate:100% | n = 17 | All the respondents indicated that some non-DSMB members had access to interim data or results. Who had access to interim data or results was as follows: 41% of respondents (7) indicated that everyone has access to interim data or results except the participants 35% of respondents (6) indicated that key institute staff has access to interim data or results • 1 respondent from this group said there was also provision for interim data to be seen occasionally and confidentially by the DSMB of another trial 18% of respondents (3) indicated that only the trial statistician and the DSMB had access to interim data or results 6% of respondents (1) allow data centre personnel to access interim data or results | All respondents from major agencies that are involved in trials indicate that interim data or results are shared with certain non-DSMB members. The largest minority of respondents (41%) indicate interim data/results are shared with everyone except the participants. |
2011 | [13] | PIs and biostatisticians on DSMBs and IRB community representatives | Total n = 309 Response rate: 31% from PIs 51% for biostatisticians 40% from IRB community members | n = 246 PIs = 152 Biostatisticians = 40 IRB community members = 54 | • 100% of Biostatisticians (40) indicate that sponsor should be masked to interim data or results • 78.3% of PIs (119) indicate that the sponsor should be masked to interim data or results • 63.0% of IRB community members (34) indicate that the sponsor should be masked to interim data or results | The majority of PIs and biostatisticians on DSMBs and IRB community representatives believe that the sponsor should be masked to interim data or results. Details about sharing with other non-DSMB members were not discussed |