Registry-based trials: a potential model for cost savings?

Abstract

Background/Aims:Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.Methods:We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.Results:Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.Conclusions:Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.

Evaluating registry-based trial economics: Results from the STRESS clinical trial

“…In this study, the STRESS Registry-Based and Pragmatic designs had much lower costs than the Explanatory design ($10,140,263 vs. $4,164,863 vs. $3,268,504, respectively). While this finding supports the position that it is the pragmatic design that accounts for a significant portion of the reduction in total costs previously reported for registry-based RCTs [ [13] , [14] , [15] ], it does not account for the further cost reduction associated with the Registry-Based versus Pragmatic design.…”

“…Some studies indicate that registry-based RCTs can dramatically reduce clinical trial costs [ 13 , 14 ]. However, other studies note that these cost savings may have resulted from their incorporation of pragmatic trial design elements and not specifically their use of registries [ 15 ]. The Clinical Trials Transformation Initiative's (CTTI) Recommendations for Registry Trials concluded that embedding RCTs within registries may be associated with improvements in [ 1 ]: data collection [ 2 ], patient identification and recruitment [ 3 ], database lock time [ 4 ], time to critical decision-making, and [ 5 ] RCT costs [ 16 ].…”

Realising the potential: leveraging clinical quality registries for real world clinical research

“…The potential advantages of registry‐based clinical trials to evaluate interventions compared with standard randomised controlled trials (RCTs) have been well documented 5‐9 . A major benefit is that registry‐based trials can represent broader population groups.…”

Cardiac Registries During the COVID-19 Pandemic: Lessons Learned

“…With an emphasis on collaboration, there have been dynamic changes in the structure of scientific activity [ 4 •], which includes the flexibility to provide funding to address urgent needs, overcoming the potentially elevated costs associated with extensive international collaboration. Registries are more cost effective than RCTs, and depending on study characteristics, can result in savings of up to USD 600,000 on data-associated costs alone [ 5 ].…”