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Health research cannot be done without the active participation of patients, and without access to their medical records to determine the safety and efficacy of treatments. Validation of assumptions from clinical studies conducted before the drugs reache the market depends on the availability of relevant treatment data and methodical comparison of multiple interventions under real-life conditions. When patients lose trust in the system, they may eventually decline to participate by refusing to make their health records available to researchers.

Medical privacy and breaches of personal health information (PHI) have been a hotly debated topic for several years. Successful adoption of electronic health records greatly depends on the willing cooperation of hospital staff. The quality and consistency of electronic health records including coding patterns are essential for the future utilization of EHRs in research. Perceived effectiveness of regulatory and technological mechanisms positively impacts trust and perceived privacy control [1].

Concerns about sharing sensitive information with industry, insurers, and employers are among the important factors that hinder trial recruitment. Carlisle et al. (2014) evaluated phase 2 and 3 trials registered in the National Library of Medicine and closed in 2011 to find out how many were terminated because of unsuccessful recruitment. Of the 2579 identified trials, 481 (19%) were either terminated for failed accrual or were completed but the enrollment was lower than 85% of target enrollment [2].

The problem of recruitment is particularly limiting in cancer trials where, according to the Institute of Medicine (IOM), more than 70% of phase 3 trials approved by the National Cancer Institute closed without meeting their accrual targets. Unfortunately, only less than 7% of cancer patients participate in clinical trials. Generalizability of findings depends on enough patients enrolling in clinical trials [3].

Terminated trials due to insufficient recruitment result in missed opportunities, waste of resources and time and NDA submission delays. A public-private partnership the Clinical Trials Transformation Initiative (CTTI) conducted a systematic review of scientific literature to prepare a survey for key stakeholders to examine barriers to trial recruitment. Answers from responders suggest that one of the most pressing problems is finding eligible patients who meet both inclusion and exclusion criteria and that the most effective ways how to mitigate this problem would be to screen electronic health records and hospital-based registries for eligible patients [4].

Methodical analysis of the safety and efficacy of treatment protocols applied in local circumstances at the facility level is one of the options researchers have to maintain and restore patient trust and willingness to participate in research.


[1] Dinev T, Albano V, Xu H, D’Atri A, Hart P. Individual’s attitudes toward electronic health records: A privacy calculus perspective. In: Gupta A, ed. Advances In Healthcare Informatics And Analytics. Switzerland: Springer International Publishing; 2016.

[2] Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. Clinical Trials: Journal of the Society for Clinical Trials. 2014;12(1):77-83. doi:10.1177/1740774514558307.

[3] Cheng S, Dietrich M, Dilts D. A Sense of Urgency: Evaluating the Link between Clinical Trial Development Time and the Accrual Performance of Cancer Therapy Evaluation Program (NCI-CTEP) Sponsored Studies. Clinical Cancer Research. 2010;16(22):5557-5563. doi:10.1158/1078-0432.ccr-10-0133.

[4] Mahon E, Roberts J, Furlong P, Uhlenbrauck G, Bull J. Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey. Appliedclinicaltrialsonlinecom. 2015. Available at:

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