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Karen Lane

Karen Lane

Highlights

Languages

  • English

Gender

Female

Johns Hopkins Affiliations:

  • Johns Hopkins School of Medicine Faculty

About Karen Lane

Professional Titles

  • Deputy Director, BIOS CTCC, Johns Hopkins University School of Medicine
  • Director, Trial Operations, BIOS CTCC, Johns Hopkins University School of Medicine
  • Co-Principal Investigator, Johns Hopkins Trial Innovation Center, Johns Hopkins University School of Medicine

Primary Academic Title

Assistant Professor of Neurology

Background

Karen is an assistant professor in the Johns Hopkins University Department of Neurology. She co-founded the BIOS Clinical Trials Coordinating Center (BIOS CTCC), an academic research organization. Karen also played a key role in organizing the Johns Hopkins Trial Innovation Center (JHU-TIC), previously known as the Johns Hopkins–Tufts Trial Innovation Center. Under Karen’s operational leadership, BIOS CTCC has successfully organized and completed more than 20 large clinical trials. Since 1999, Karen has served as key personnel on numerous grants, primarily funded by the National Institutes of Health and the FDA Orphan Products Grants Program, and has co-authored over 90 publications on clinical trial operations and innovations.

 

Karen’s work has led to the development of a range of technical and organizational innovations in clinical trials. These include advancements in web-based electronic data collection systems, trial performance metrics, strategies for improving site and participant retention, investigator-facing websites, online training platforms for skill certification, and electronic regulatory repositories. Karen has also authored or co-authored instructional modules for more than 15 multicenter national and international trials. Her trainees include a wide range of trialists—principal investigators, coordinators, and project managers—many of whom now hold leadership roles in academic research at Johns Hopkins and other institutions. As director of the JHU ICTR Multicenter Study Operations Training Program and a former faculty mentor for the Ann Dana Kusch Predoctoral Fellowship in Clinical Research and Innovation, Karen mentors investigators across Hopkins and other CTSA hubs in implementing efficient, streamlined clinical trial methodologies.

 

Karen’s academic focus centers on the science and practice of team-based clinical research. Her research and training programs emphasize lean management principles aimed at improving the efficiency and effectiveness of clinical trial operations. To address common delays in preparing research sites for patient enrollment, Karen developed an innovative educational program that accelerates the study start-up process. This program has been implemented across 15 NIH-funded multicenter trials involving more than 200 sites nationwide.

 

Collectively, Karen’s work bridges innovation, operations, and training to improve how complex clinical trials are designed and executed. Through her leadership, she continues to advance efficient, scalable, and team-based approaches that strengthen the impact of clinical research nationwide.

Recent News Articles and Media Coverage

Research Interests

Team Science, Clinical Trial Implementation Science

PubMed - Publications

Selected Publications

  1. Majkowski R, Hillery S, Barney BJ, Ryu P, Woo E, McBee N, Mould A, Eyzaguirre LM, Holthouse E, Lane K. Building games into multicenter clinical trial systems to boost trial engagement. Trials. 2026 Feb 13;27(1):218. doi: 10.1186/s13063-026-09498-6. PMCID: PMC13005411.
  2. Gawad A, Mendoza J, Singleton M, Majkowski R, Hopkins E, Carll J, MacInnis C, Amirault D, Jackson B, McBee N, Mould A, Eyzaguirre LM, Pessoa-Gingerich C, Shoham S, Sullivan D, Lane K. Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency. Contemp Clin Trials. 2025 Dec 24;161:108207. doi: 10.1016/j.cct.2025.108207. Epub ahead of print. PMID: 41453518.
  3. Hillery S, Majkowski R, Wang Y, Barney B, Eyzaguirre L, Mould A, McBee N, Woo E, Holthouse E, Wiley K, Waddy SP, Ford D, Hanley DF, Lane K. Accelerating start-up cycles in investigator-initiated multicenter clinical trials. J Clin Transl Sci. 2025 Oct 24;9(1):e249. doi: 10.1017/cts.2025.10180. PMCID: PMC12695510
  4. Sorensen G, Remillard W, Schlechter M, Kampp M, Whisler Brady C, Kildahl K, Mould A, Ziai W, Lane K, Van Eldik LJ, Distasio A, Lu J, Sansing LH, Hanley DF, Magid-Bernstein J. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. J Clin Transl Sci. 2025 Sep 12;9(1):e215. doi: 10.1017/cts.2025.10152. PMID: 41040632; PMCID: PMC12485565
  5. Hanley DF, Lane K, *McBee N, Eyzaguirre LM, Mould WA, Holthouse E, Baird JF, Casey JD, Wilkins CH, Waddy SP, Wiley KL, Hassani S, Hildreth M, Nanni A, Edwards TL, Thompson DD, Stroud M, Serdoz E, Kennedy N, Nelson SJ, Jones M, Boone LR, Lawrence C, Cook SK, Chen T, Cohen J, Dilts N, Cheng AC, Grout RW, Miller ER, Casella JF, Benjamin DK, Selker HP, Palm ME, Poole L, Burr JS, Ford DE, Bernard GR, Harris PA. Conducting multicenter trials through the trial innovation network comprehensive consultation. https://doi.org/10.1016/j.cct.2026.108334. PMID: 42086122.

Honors

  • American Heart Association, Founders Award, 1983
  • American Medical Association Award of Appreciation for service on the Assembly of Review Committee Chair, Committee on Allied Health Education and Accreditation, 1990
  • Top 10 Clinical Research Achievement Awardee: Early COVID-19 Treatment with COVID-19 Convalescent Plasma, Clinical Research Achievement Awards, Clinical Research Forum. I served as the clinical coordinating center lead for the Early Outpatient COVID-19 Plasma Treatment Research Study (CSSC-004), which was named a top 10 award winner for the national 2023 Clinical Research Achievement Awards. Sponsored by the Clinical Research Forum, the Clinical Research Achievement Awards honor those who demonstrate a commitment to excellence and innovation in clinical research. This awards program seeks to recognize research that significantly advances health and welfare. 2023
  • Awarded Reviewer Certificate in recognition of contribution to manuscript review in BMC Digital Health, 2025

Memberships

  • Member, Association of Clinical Research Professionals, 2000-2015
  • Member, Society of Clinical Research Associates, 2000-2015
  • Member, American Academy of Neurology, 2014-present