Barriers to Clinical Trial Efficiency and Patient Access: The Heart Failure Collaboratory Industry Survey

Abstract

ABSTRACTAimsClinical trial inefficiency and lack of patient access to novel therapies have been identified as key barriers to successful heart failure innovation. The Heart Failure Collaboratory (HFC) is a consortium developed to identify and address barriers to bringing drugs and devices to market. The HFC performed an electronic cross-sectional survey of key leaders within industry to collate and interpret a sample of viewpoints on these challenges.Methods and ResultsFrom August to September 2018, self-administered survey data were electronically collected from industry partners. Group comparisons were made via Fisher’s Exact or chi-square test. Respondents most commonly rated the United States Food and Drug Administration (44.2%), Health Canada (39.5%) and European Medicines Agency (32.6%) as efficient. Respondents rated the top 3 areas with the greatest opportunity for regulatory agencies to improve efficiency: ‘improve usefulness of agency feedback’ (48.8%); ‘improved timeliness of agency responses’ (41.9%); and ‘pre-specification of required magnitude of clinical effect’ and ‘limit excessive data requirements’ (32.6%). Respondents rated items of ‘excessive clinical site staff workload’ (55.8%), ‘overly complex case report forms’ (51.2%) and ‘data input errors’ (39.5%) as the top 3 factors influencing data quality. Respondents rated items of ‘onerous prior authorization requirements’ (51.2%), ‘availability of decision-making rationale’ (46.5%) and ‘rationality of access barriers created by payers’ (44.2%) as the top 3 impediments to improving patient access to approved therapies.ConclusionThis broadly distributed survey of industry respondents identified multiple specific barriers to heart failure clinical trial efficiency and patient access, which should help direct efforts toward improvement.