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Publications

Koneksa conducts rigorous research to push the boundaries of next-generation digital biomarkers that are used to predict, diagnose, and assess efficacy of novel treatments in various health conditions. Learn more about our research.

25

Izmailova, E.S., and Ellis R. (2022). “When Work Hits Home: The Cancer-Treatment Journey of a Clinical Scientist Driving Digital Medicine.” JCO Clin Cancer Informatics(6):e2200033. doi: 10.1200/CCI.22.00033.

24

Ellis, R., et al. “Sensor Verification and Analytical Validation of Algorithms to Measure Gait and Balance and Pronation/Supination in Healthy Volunteers” Sensors (Basel). 2022 Aug 20;22(16):6275. doi: 10.3390/s22166275.

23

Celik, Y., et al. “Sensor Integration for Gait Analysis.” Encyclopedia of Sensors and Biosensors Volume 4, 2023, Pages 263-283. doi.org/10.1016/B978-0-12-822548-6.00139-4.

22

Pearlmutter, A., et al. “Clinical Trial Digital Endpoint Development: Patient and Provider Perspectives on the Most Impactful Functional Aspects of Parkinson’s Disease.” MDS Virtual Congress 2021. International Parkinson and Movement Disorder Society, MDS Virtual Conference. September 8, 2021.

21

Pearlmutter, A., et al. “Parkinson’s Disease Functional Impacts Digital Instrument (PD-FIDI): Studies Preceding Clinical Validation.” International Parkinson and Movement Disorder Society, MDS Virtual Conference. September 8, 2021. 1298

20

Kelly, P., et al. “Capability of Accelerometers in Wearable Devices for Measurement of Postural Tremor, Gait and Balance, and Nocturnal Scratching.” The International Society for CNS Clinical Trials and Methodology Conference. September 8-9, 2022; Boston, MA.

19

Izmailova, E.S., and Wood W.A. “Biometric Monitoring Technologies in Cancer: The Past, Present, and Future.” JCO Clin Cancer Inform. 2021;5(5):728-733. doi:10.1200/CCI.21.00019.

18

Izmailova, E.S., and Reiss T. F. “Closer to the Patient Means Better Decisions: Wearable Remote Monitoring of Patients with COVID-19 Lung Disease.” Clin Transl Sci. 2021;14(6):2091-2094. doi: 10.1111/cts.13085.

17

Izmailova, E.S., et al. “Remote Cardiac Safety Monitoring Through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.” Digit Biomark. 2021;5(1):103-113. doi: 10.1159/000515110.

16

Izmailova, E.S., et al. “Daily Step Counts to Predict Hospitalizations During Chemoradiotherapy for Head and Neck Cancer.” American Society of Clinical Oncology Annual Meeting. June 4-8, 2021. J Clin Oncol 39, 2021 (suppl 15; abstr 1571) doi: 10.1200/JCO.2021.39.15_suppl.1571.

15

Huang, C., et al. “Compliance Analysis for Remote Spirometry in Subjects with Mild to Moderate Asthma.” American Thoracic Society Conference, Abstract A1733. May 14, 2021. San Diego, CA.

14

Kelly, P., Ellis, R., et al. “Feature Development of Digital Measures for the Finger Tapping Task.” ISCTM 17th Annual Scientific Meeting, April 2021.

13

Huang, C., et al. “Remote FEV1 Monitoring in Asthma Patients: A Pilot Study.” Clin Transl Sci. 2021;14(2):529-535. doi: 10.1111/cts.12901.

12

Ellis, R., et al. “Development of an Algorithm for the Evaluation of Gait and Balance Impairments in CNS Disorders.” International Society for CNS Clinical Trials and Methodology Autumn Conference. September 21-25, 2020.

11

Kelly, P., et al. “Comparison of Accelerometers Used for Measurement of Upper Body Postural Tremor, and Gait and Balance.” International Parkinson and Movement Disorder Society MDS Virtual Congress. September 12-16, 2020. Abstract 1415.

10

Ellis, R., et al. “Analytical Validity and Operational Tolerance of a New Algorithm in Healthy Individuals to Calculate Gait and Balance Feature Scores From an iPhone Application.” International Parkinson and Movement Disorder Society MDS Virtual Congress. September 12-16, 2020. Abstract LBA8.

9

Kelly, P., et al. “Analytical Validity of a New Algorithm to Identify Walking Periods in Continuous Wrist Worn Accelerometer.” CNS Summit October 29-November 1, 2020. Boca Raton, FL.

8

Izmailova, E.S., et al. “Remote Digital Monitoring for Medical Product Development.” Clin Transl Sci. 2020;14(1):94-101. doi.org/10.1111/cts.12851.

7

Goldsack, J.C., et al. “Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs).” NPJ Digit Med. 2020;3(1):55. doi.org/10.1038/s41746-020-0260-4.

6

Huang, Q., et al. “In-House” Data on the Outside—A Mobile Health Approach.” Clin Pharmacol Ther. 2020;107(4):948-956. doi.org/10.1002/cpt.1790.

5

Izmailova, E., et al. “Daily Step Counts to Predict Hospitalizations During Concurrent Chemoradiotherapy for Solid Tumors.” J Clin Oncol. 2019;37(27_suppl):293-293. doi.org/10.1200/JCO.2019.37.27_suppl.293.

4

Izmailova, E.S., et al. “Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine.” Clin Transl Sci. 2019;12(6):677-686. doi.org/10.1111/cts.12673.

3

Izmailova, E.S., et al. “Evaluation of Wearable Digital Devices in a Phase I Clinical Trial.” Clin Transl Sci. 2019;12(3):247-256. doi.org/10.1111/cts.12602.

2

Izmailova, E.S., et al. “Wearable Devices in Clinical Trials: Hype and Hypothesis.” Clin Pharmacol Ther. 2018;104(1):42-52. doi.org/10.1002/cpt.966.

1

Leptak C., et al. “What Evidence Do We Need for Biomarker Qualification?” Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599.