Table 4 Other information that should be shared
Do you think that any other information should be shared during the interim of a randomized controlled trial by the Data Safety Monitoring Board (DSMB)? | ||||
Total responses to question: 210 | ||||
Response | Count; % [95% CI] | |||
No | 109; 51.9% [45.0% to 58.8%] | |||
Yes | 101; 48.1% [41.2% to 55.0%] | |||
For those that answered Yes, what other information the DSMB should share at a trial’s interim, with whom it should be shared, why, and how useful it is to share that information? | ||||
What should be shared? | Count; % [95% CI] A | With whom should that information be shared? | Why should this information be shared? | Usefulness to share* mean [95% CI]; median [IQR] |
Information about trial conduct (e.g., protocol adherence, operational issues, enrollment, recruitment, treatment adherence, trial management, data quality and completeness) | 67; 31.9% [25.7% to 38.6%] | • Sponsor, • Steering Committee, • Investigators, or any relevant party | To ensure that the trial is conducted well with integrity and ethically. Information about trial conduct issues will help instigate corrective measures | 9.16 [8.89 to 9.42]; 10 [8–10] |
Safety Issue or concern | 50; 23.8% [18.3% to 30.1%] | • Sponsor • Steering Committee • Investigator(s) • Ethics Committee | Based on the type of safety concern, investigators may need to increase monitoring to protect patient safety, change the trial’s protocol or request new consent from enrolled patients based on new safety risk | 9.35 [9.02 to 9.69]; 10 [9–10] |
DSMB trial recommendations such as stopping or continuing the trial and possible sample size adjustment. Information shared does not include unmasking group information. | 21; 10.0% [6.3% to 14.9%] | • Sponsor • Steering Committee | To protect the trial’s integrity, patient safety, and trial resources. Due diligence to patients and the public good | 9.52 [9.08 to 9.96]; 10 [10–10] |
Overall patient baseline characteristics | 9; 4.3% [2.0% to 8.0%] | • Any relevant party | Help study team understand if their enrollment is targeting the intended population. Protect the generalizability of the study. Help evaluate recruitment procedures and analysis plan | 8.0 [7.27 to 8.73]; 8 [8–8] |
Any relevant data or raw data | 4; 1.9% [0.5% to 4.8%] | • Any relevant party | Sharing allows for broader stakeholder discussion of the benefits of treatment versus the risks of adverse events than just a committee with minimum involvement. There is no harm in this if efficacy stopping rules are pre-specified | 9.33 [8.68 to 9.99]; 9 [9–9.5] |
Important information from outside of the trial that is relevant to the current trial, the enrolled patients, the sponsor and the investigators | 2; 1.0% [0.1% to 3.4%] | • Steering Committee • Study team members | During a long-term trial, results from other trials may affect the ethics, scientific rationale, care of patients and conduct of the current trial | 9.5 [8.52 to 10]; 9.5 [9.25–9.75] |