The COVID-19 Clinical Research Coordinating Committee is available for consultations, questions, and discussions about ranking for inpatient studies.
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Applications for approval of COVID research prior to IRB and ORA is no longer required.
Prioritization Process for Therapeutic Adult Inpatient COVID-19 Research
PRESENT
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.
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 below, and prioritize the clinical trial in the context of other actively recruiting trials at Johns Hopkins by ranking the studies. The priority list linked below is updated weekly and posted on Microsoft Teams, and is used to guide study recruitment when a patient is a candidate for more than one active clinical trial.
Current Priority Ranking for Enrolling Hospitalized Patients in COVID-19 Clinical Trials (JHED login required)
Guiding Principles for Prioritizing COVID-19 Research
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.
