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. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement No funding was obtained for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: As this was a survey of industry participants, IRB approval/exemption was not required (as no patient subjects were assessed or harmed during this study). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The primary and corresponding author take full responsibility for primary data collection and analysis.