COVID-19 Johns Hopkins Clinical Research Coordinating Committee

We appreciate that many Johns Hopkins faculty and staff are using all of their knowledge and creativity to address this pandemic. At the same time, we need to recognize that those with the disease cannot be asked to be part of multiple protocols that are burdensome and duplicative.

The rationale for coordinating COVID-19 clinical research include:

  • Risks to patients, study participants, and staff during the pandemic.
  • Patients with COVID-19 presenting to hospitals and facilities across the Johns Hopkins Health System are being cared for by newly formed clinical teams.
  • Enhance research participation across the health system to inform the development of evidence-based means of treating COVID-19.
  • Not overwhelm patients with multiple requests regarding research participation.
  • The need to be sensitive to rapidly emerging data (interventions and the contours of the pandemic).
  • The opportunity to learn from different expertise.
  • Limits to the number of treatment trials we can support in terms of the number of patients with COVID-19 that meet inclusion/exclusion criteria and resources needed to open, maintain and successfully complete clinical trials.
  • Our commitment that patients participate in research that is likely to yield interpretable results.
  • Prioritize which protocols will receive university support, including review by the IRB.
  • Prioritize supplies for non-essential resources such as PPE and reagent or specimen collection and transfer materials.
  • Use resources efficiently.

 

Please visit each of the sections below to learn about the review process.


Guiding Principles in COVID-19 Research Prioritization

Research Imperative: Given uncertainty about the appropriate treatment of COVID-19 as well as its diagnosis and prevention there is an imperative to conduct research.

Scientifically and Ethically Sound Research: Research must be scientifically sound and meet standard ethics and regulatory criteria.

Potential to Be Informative: Research that is rigorously designed and most likely to be informative gets priority.

Responsible Stewardship: Prioritization will take into account the impact of research on precious resources (including patients, staff, materials and funds) to minimize risks and burdens.

Balanced Portfolio: Prioritization will aim to achieve a balanced institutional portfolio with regard to characteristics including stage of disease, phase of research, population, equity, and expected enrollment target.

Collaboration: Contribute to large multi-center randomized controlled clinical trials that are likely to be completed and thereby have the potential to establish or change standards of care or to identify convincingly which interventions are safe and effective.

Equity: Prioritization will take into account the needs and interests of those most affected by COVID-19.

Changing Priorities: Rapidly changing understanding and contours of the pandemic may shift priorities.

Fair Allocation: Access to scarce resource opportunities must be allocated fairly.

Transparency: The process of decision-making regarding research prioritization must be transparent to relevant stakeholders.

Prioritization of Intervention/Therapeutic Clinical Trials

This section explores nuances of risk as it might counterbalance benefits. Before IRB submission, investigators must submit their study for review by the COVID-19 Clinical Research Coordinating Committee (CRCC) using the online Johns Hopkins COVID-19 Research Plan Form. The purpose of the CRCC review is to establish the study priority according to the guiding principles and provide consultative advice on trial implementation.

Investigators for interventional clinical trials will provide the CRCC members with the study protocol and present an overview of their clinical trial via Zoom using the provided PowerPoint template. The investigators should present the study in the framework of the guiding principles for COVID-19 clinical research at Johns Hopkins and outline the specific plans for study implementation. Ongoing studies should provide an update of study progress and review any barriers to successful implementation.

CRCC members will evaluate interventional studies considering the guiding principles and prioritizing the clinical trial in the context of other actively recruiting trials at Johns Hopkins by ranking the studies. The priority list will be posted on Microsoft Teams and used to guide study recruitment when a patient is a candidate for more than one active clinical trial.

Members (including co-chairs)

 

 Richard Rothman, MD, PhD (co-chair)  Janet Mighty, MBA
David Thomas, MD, MPH (co-chair) Richard Moore, MD
Robin Avery, MD Sumati Murli, PhD
Ryan Belecanech, MD Megan Ossing
Roy G. Brower, MD VInciya Pandian, PhD, MBA, MSN, RN, ACNP-BC, FAAN
Shaker M. Eid, MD, MBA, CPE, SFHM Deborah Persaud, MD
Daniel Ford, MD, MPH Sarina Sahetya, MD,MHS
Rachel Hampton Lauren Sauer, MS
Craig Hendrix, MD Zishan Siddiqui, MD
Maureen Horton, MD Megan Singleton, JD
Noreen Hynes, MD, MPH Jeremy Sugarman, MD
Kim Kafka, BSN, RN Mark Sulkowski, MD
Gregory Kirk, MD, PhD, MPH Stephanie Swords, MA, CCRP
Carol Kobrin, PhD Bob Wise, MD
Jackie Lobien, BSN, ACRP-CP Tamara Lotan, MD

 

Contact Us

If you have questions for the committee, please contact:
Lauren Sauer, MS
Director of Operations for the Johns Hopkins Office of Critical Event Preparedness and Response (CEPAR)
Assistant Professor of Emergency Medicine
lsauer2@jhmi.edu