SYSTEMS-LEVEL QUALITY IMPROVEMENT
Improving the Patient-Clinician Interface of Clinical
Trials through Health Informatics Technologies
Received: 24 January 2018 / Accepted: 18 May 2018
Springer Science+Business Media, LLC, part of Springer Nature 2018
The current state of clinical trials underscores a need for timely interventions to reduce the cost and length of the average trial.
Newly developed health informatics technologies—including electronic health records, telemedicine systems, and mobile health
applications—have recently been employed in a wide range of clinical trials in an effort to improve different aspects of the
clinical trial process. The current review will focus on the observed benefits and drawbacks of using such technology to improve
various patient-centered aspects of the clinical trial process, namely its potential to improve patient recruitment, patient retention,
and data collection. Broad future challenges and opportunities in the field as a whole will also be covered.
Keywords Health informatics
Electronic health records
Despite the importance of clinical trials, attempts by the phar-
maceutical industry to conduct efficient, timely trials have
been largely unsuccessful: the average cost to conduct a
Phase 1 clinical trial is $3.4MM (phase 2 and phase 3 trials
cost ~2× & ~6× as much, respectively), and less than 10% of
all agents evaluated in clinical trials ultimately receive approv-
al from the Food and Drug Administration (FDA) [1, 2]. The
lengthy time-frame and high cost of the average clinical trial
necessitate an investigation into potential tools to mitigate
This review will focus on technology-driven improvements
in the domain of the patient-clinical trial interface (rather than
the potential usage of informatics tools to aid in clinical data
analysis). Further, it is important to note that the current re-
view only focuses on explanatory pharmaceutical trials, al-
though advancements in health informatics technologies can
be applied to (1) a wide variety of clinical trial designs (e.g.
comparative effectiveness trials, randomized community-
level interventions, etc.) & (2) alternative patient-facing issues
(concerning patient privacy and informed consent, tracking
adverse events, delivering the desired intervention, etc.).
Current patient-facing issues in the clinical
trial process: The need for informatics?
Patient recruitment issues are one of the main factors contrib-
uting to study delays: 45% of delays greater than 6 months are
caused by recruitment challenges, given that 48% of clinical
trials sites fail to meet enrollment goals [3, 4]. This manifests
in extraneous costs given (1) the need to operate enrollment
sites for extended periods of times (which average $37 k daily)
and (2) high opportunity costs for the pharmaceutical compa-
ny (ranging from $600 K-$8MM daily in lost sales) .
Geographical barriers are an important factor contributing to
these patient recruitment issues: if patients are too far from
clinical trial sites, they potentially (1) will not know about
relevant clinical trials or (2) will be reluctant to register for a
trial given difficulties reaching the trial site [6, 7]. This per-
petuates socioeconomic disparities in clinical trials, as those
who lack financial means to travel to clinical trial centers are
less likely to register as well .
The use of innovative technologies offers a potential solu-
tion to these issues. Electronic Health Records (EHR) can be
This article is part of the Topical Collection on Systems-Level Quality
* Jake Carrion
Department of Biomedical Informatics, Columbia University, 622 W
168th St, New York, NY 10032, USA
Journal of Medical Systems (2018) 42:120