Validation of the all-comers design: Results of the TARGET-AC substudy

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

“…Out of the 24 articles included and reporting the use of a population/disease registry for a clinical trial pre-screening [ 42 – 65 ], we identified nine disease domains/fields: nine articles were associated with oncology, three articles with the cardiovascular field, two papers with inflammatory diseases, one paper with autoimmune diseases, one paper with pulmonary diseases, one paper with hepatology, two papers with endocrinology, four papers with neurological and/or neuromuscular disorders, and one paper associated with metabolic disorders. Among the included articles, a majority were based on registries from the USA (13 out of 24) [ 53 – 65 ], with the rest describing either single-European-country registries or other international registries, and one registry from Israel [ 42 – 52 ]. Descriptive characteristics of the included papers are available in Supplementary material 4 .…”

“…Two included studies reported using a combination of local and national registries (Supplementary material 4 , papers 24 and 5) [ 54 , 62 ]. Only two international registries were reported being used for trial pre-screening (Supplementary material 4 , papers 15 and 11) [ 47 , 52 ]. We observed that 50% of the included studies reported pre-screening for drug trials (Supplementary material 4 , papers 22/16/15/10/21/1/14/8/7/2/6/23) (respectively [ 44 , 46 – 48 , 51 , 55 , 57 , 59 – 61 , 63 , 65 ]), and 50% of non-drug trials (Supplementary material 4 , papers 12/18/20/9//13/11/17/24/19/4/5/3) (respectively [ 42 , 43 , 45 , 49 , 50 , 52 – 54 , 56 , 58 , 62 , 64 ]).…”

“…In terms of pre-screening methodology, only six studies (Supplementary material 4 , papers 12/22/16/9/21/11) did not specify in what way the registry was used to perform trial pre-screening (respectively [ 42 , 44 , 46 , 49 , 51 , 52 ]).…”