Comparison of Institutionally Chartered DSMBs, NIH DSMB guidelines, and FDA DSMB guidelines
| Characteristics in common for all DSMBs | |||
| Primary responsibilities | Assure safety of participants Preserve integrity of trial Ensure reliability of results Maintenance of data integrity and confidentiality | ||
| A priori statistical determinants | Yes | ||
| Charter or equivalent | Yes | ||
| Multidisciplinary composition of board | Yes | ||
| Confidentiality procedures | Defined within charter and maintained within board | ||
| Maintenance of data integrity | Defined within charter and maintained within board | ||
| Conflict of interest | Avoidance of any actual or apparent | ||
| Risk assessment | Moderate to high-risk trials | ||
| Characteristics that may differ between IC-AHC DSMBs and government-sponsored or industry-sponsored DSMBs | |||
| Entity | AHC IC-DSMB | Government-sponsored DSMB | Industry-sponsored DSMB |
| Characteristic | |||
| Structure | Institutional charter | Federal guidelines for charter | FDA guidance |
| Composition of members | Specific to needs; defined in charter | Federal guidelines | FDA guidance |
| Funding | Research grants, institutional, may be unfunded | Government | Industry |
| Investigational setting | AHCs | Government-funded trials and AHCs | Varied |
| Investigator initiated | Yes | Yes | No |
| Single/multi-site | Single or occasionally small or limited multi-site (4–6 sites) | Single or multi-site | Single or multi-site |
| Trial size | Interventional trial: small (<100) Observational study: small–intermediate (100 s) | Interventional trial: small–large (<100–1000+) Observational study: small–large (<100 to 1000+) | Small (<100 in phase I) to large interventional trial (1000+) |
AHC, academic health center; DSMB, Data and Safety Monitoring Board; FDA, Food and Drug Administration; IC-DSMB, institutionally chartered Data and Safety Monitoring Board; NIH, National institutes of Health.