Clinical Evidence


Increase in Drug Concentration Levels

in stroke patients on DOACs


Mean Cumulative Pharmacokinetic Adherence

over 24 weeks across indications2


Treatment Completion Rates

in patients with hepatitis C and tuberculosis3

Drug Development: clinically-validated to increase adherence to the IMP.

AiCure is working with top-10 pharmaceutical sponsors in global Phase I-IV studies. Sponsors benefit from behavior and computational diagnostics tracking across large patient populations to improve signal detection and clinical outcomes.

AiCure Platform positively impacts adherence and retention

AiCure ensures optimal adherence and protocol compliance to help determine the true safety and efficacy of investigational compounds.



Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia.

(Earle E Bain, Laura Shafner, David Walling, Ahmed Othman, Christy Chuang-Stein, John Hinkle and Adam Hanina). JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18.


Using an Artificial Intelligence Platform on Mobile Devices to Monitor and Increase Adherence in Subjects with Schizophrenia. 

(Laura Shafner, Markus Abt, Russell Kinch, Paul Tamburri, Adam Hanina and Daniel Umbricht). Presented during the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, May 29 – June 2, 2017, Miami Beach, FL, USA. Study BP29904: NCT02824055.


Using Artificial Intelligence Platforms to Monitor and Identify Early Nonadherence Activity Based on Visual Confirmation of Medication Ingestion. 

(Laura Shafner, Maggie McCue, Anne Rubin, Xinxin Dong, Elizabeth Hanson, Atul R. Mahableshwarkar, Adam Hanina and Thomas A. Macek). Presented during the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, May 29 – June 2, 2017, Miami Beach, FL, USA. Study 2002: NCT02477020.


Using Artificial Intelligence Platforms to Enhance Study Design in Schizophrenia Trials.

(Laura Shafner, Ryan Bardsley, Gabriella Hall and Adam Hanina). Presented during the Schizophrenia International Research Society, 4-8 April 2018, Florence, Italy.






Understanding behaviors that are unique to clinical trials

Up to 20% of clinical trial participants never actually take the study drug.

AI Platforms are being used to identify and screen out participants to improve the accuracy of trial results.

Using Computer Vision and Machine Learning to Identify Patterns of Fraudulent Participant Activity in CNS Trials.
(Shafner L, Bardsley R, Hall G and Hanina A.) Presented during the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, Miami Beach, Florida (May 2018)





Population health: reducing costs and improving clinically-meaningful outcomes

RCT: Stroke patients increased adherence to direct oral anticoagulants by 67%

Although DOACs have reduced the need for regular monitoring, they have also placed pressure on patients to self-manage. Suboptimal rates of adherence to DOACs are going undetected, placing patients at increased risk of stroke and bleeding.

A randomized, parallel-group, 12-week study was conducted in adults with recently diagnosed ischemic stroke receiving any anticoagulation. Patients, some with little experience using a smartphone, successfully used the technology and demonstrated
a 50% improvement in adherence based on plasma drug concentration levels. For patients receiving direct oral anticoagulants, absolute improvement increased to 67%.

(Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A). Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419

Presented during the Connected Health Symposium, October 20-21, 2016, Boston, MA. Study NCT02599259.


Hepatitis C: Achieving close to 100% adherence and retention in real-world settings

Patients used AiCure to monitor adherence to fixed-dose ledipasvir and sofosbuvir.


Clinical Trial Methodology: Using AI to Refine Research

The value in using accurate dosing data as eSource submission

Sponsors are using AiCure logged adherence data as the primary of adherence. The strong relationship to pharmacokinetic data (PK compliance rate) is critical.




Determining safety and efficacy results based on accurate data

The ISCTM Nonadherence Working Group was established in June 2014 to investigate aspects of nonadherence and the potential impact on drug development.

Shiovitz TM, Bain EE, McCann DJ, Skolnick P, Laughren T, Hanina A, Burch D. Mitigating the Effects of Nonadherence in Clinical Trials. J Clin Pharmacol. 2016 Sep;56(9):1151-64.


Using AI to accentuate the signal/noise ratio

Quantifying the benefit of accurate data using two models to link concentration to drug effect (PK-PD relationship)

Chuang-Stein, C; Hinkle J; Hanina A; Shafner L. The Impact of Adherence. April 2016


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