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

Aims: Clinical 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 Results: From 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. Conclusion: This 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.