For interventional clinical studies that enroll inpatients in BJH or SLCH, only those trials that have been reviewed and prioritized by the COVID Clinical Studies Prioritization Committee and that have obtained IRB approval are approved for recruitment. For additional details, please see the “Active Interventional Study Details + Enrollment Prioritization” Excel document linked below.
All prospective interventional studies that plan to enroll inpatients at BJH or SLCH must submit a description of their work below.
Interventional Clinical Studies
View listing and study details below for all IRB-approved, interventional clinical studies that are approved for enrollment at Washington University by the COVID Clinical Studies Prioritization Committee. This listing contains details about the enrollment prioritization for all active interventional trials and is only available to those with a WUSTL Key.
- Active Interventional Studies – Prioritization Ranking (pdf) (password protected)
- Active Interventional Study Details + Enrollment Prioritization (Excel) (password protected)
Prioritizations may be modified as new interventional trials are approved so study teams should review this document regularly. For questions, contact Tera Jarvis (firstname.lastname@example.org). Details on the approval process are available below under “COVID-19 Clinical Research Review”.
COVID-19 Clinical Research Review
Washington University faculty and staff have exerted substantial effort in using their clinical and scientific expertise to address the many complexities of the COVID-19 pandemic. Since early 2020, study review processes that were put in place to reduce strain on patients, front-line providers, and critical health care resources have been periodically reviewed and scaled back, reflecting the evolution of the pandemic. Effective March 14, 2022, the ICTS will further restrict the scope of its COVID-91 study review to prospective interventional trials that plan to enroll inpatients at BJH or SLCH.
As they are now, such studies must be submitted via the ICTS COVID-19 Research survey and will be reviewed first by the COVID Clinical Studies Committee (CCSC), with particular attention to the burden they add on patients, front-line providers, and resource availability. For such studies that do not fall into the IRB’s minimal risk category, approval by the CCSC will be required before IRB review can proceed. After CCSC approval and near the time of IRB approval, the Clinical Studies Prioritization Committee (CSPC) will review studies and determine a ranked prioritization for enrollment. Learn more about each committee below.
The CCSC is currently only reviewing prospective interventional clinical studies that plan to enroll inpatients at BJH or SLCH. Investigators for such studies should still submit study details to the CCSC and await feedback prior to completing their IRB submission. In general, studies will be reviewed in a format similar to an NIH study section, with proposals receiving a priority score and overall CCSC disposition. Final committee feedback will be provided in a communication to the lead investigator (with cc to HRPO/IRB staff) from the CCSC and ICTS leadership. For some potentially meritorious studies that have concerns identified, the CCSC may invite revision and re-submission. We expect investigators to receive feedback within approximately 2-4 weeks of ICTS survey completion, PROVIDED sufficient information is submitted to enable a quality review. Review times will be highly dependent on the level of detail provided. Investigators should be aware that IRB fees are charged for IRB/HRPO work irrespective of whether studies are approved.
If the CCSC approves a study proposal, the IRB review process will proceed. Interventional studies approved by the CCSC and IRB will undergo subsequent review by the COVID-19 Clinical Studies Prioritization Committee to determine enrollment prioritization relative to other active interventional trials.
Minimum Requirements for CCSC Review
At a minimum, the following study details will be required before a review will be initiated:
- An updated study protocol, or if not available, details on the following:
- The study hypothesis and objectives.
- Participant eligibility criteria (including whether they are COVID positive, under evaluation for COVID, in convalescent phase, or other status).
- The locations and means by which participants will be recruited.
- The nature (drug, device, biologic, other) and regulatory status (approved indication, off-label use, investigational) of the intervention.
- Targeted recruitment goal with brief statistical justification.
- Nature (in-person visits, remote visits, blood/imaging/other testing methods) and duration of follow-up assessments.
- Safety precautions and monitoring.
- Ways in which COVID-19 infection of the participants, research workers, and others will be avoided.
In addition, the following documents are also helpful for review:
- Informed consent document, if available
- If study involves drug, the Investigator Brochure and/or Pharmacy Manual
- Any other relevant study documentation as available
In an attempt to reduce the potential for burden on our patients and staff and ensure enrollment in the highest priority studies, the University Executive Faculty approved the formation of a COVID-19 Clinical Studies Prioritization Committee (CSPC). The CSPC is tasked with reviewing all IRB-approved prospective interventional clinical studies that plan to enroll inpatients at BJH or SLCH to determine a ranked prioritization for enrollment. Additional details on the prioritization scheme and process will be shared to ensure the utmost transparency for all investigators.
Study investigators will be contacted after prioritization has been assigned. Investigators should check this page regularly for additional updates.
The mission of the Clinical Studies Prioritization Committee is to assign priorities for subject enrollment for all interventional clinical studies related to COVID-19 being carried out at Washington University Medical Center. The principal aims are:
- to support meritorious studies to define therapeutic approaches;
- to provide a framework for streamlining subject enrollment in IRB-approved COVID-19 clinical studies;
- to minimize stress and confusion potentially generated by uncoordinated approaches to patients and families asking for participation in multiple studies; and
- to amplify the public health impact of ongoing COVID-19 research by ensuring timely and complete subject enrollment in prioritized studies.
- In general, studies funded by the NIH will have top priority, followed by Washington University investigator-initiated studies, followed by industry-funded studies.
- Clinical importance and scientific quality will be heavily weighed, including the assessment of the COVID-19 Clinical Studies Committee.
- Multi-center trials that are likely to answer important questions will be prioritized.
- Potential for enrolling subjects across the socio-demographic spectrum will be considered.
- The impact of studies on resource utilization will be considered.
- Emphasis will be placed on achieving a balanced portfolio of research studies that will maximize enrollment from the range of COVID-19 patient groups encountered at the medical center; e.g. ambulatory emergency room, hospitalized non-ICU, ICU non-mechanically ventilated, ICU requiring mechanical ventilation.
- There will be commitment to transparency in processes and outcomes.
- Evaluations will be objective and non-biased.
- Patients will be approached for participation in research studies only with the approval of their primary attending physician or an appropriate representative of the care team if the primary attending physician is not available.
- Patient autonomy will be respected. Patients will be approached first regarding participation in the study with highest priority for their patient group as defined in item 6. If the patient is found not to be eligible, or participation is declined, the patient will be provided the opportunity to participate in other research studies for which they meet the eligibility requirements.
Conflict of Interest Policy: CCSC and CSPC
Committee members with an actual or potential conflict of interest with a study under review shall inform the Committee Chair. A major conflict may include serving as an investigator on the study under evaluation, accepting compensation (consultant fee, honorarium, research support, etc.) from the study sponsor, having a financial interest (salary, equity, royalties, or related ownership interest) that may be affected by the outcome of the study, or having any other relationship defined by WU Research Conflicts of Interest policies. Members with a major conflict will not participate in discussions of the study in question. A minor conflict includes being in the same division within the Department of Medicine or the same department for departments other than Medicine as the principal investigator of the study under evaluation. A minor conflict does not require recusal unless the Committee member feels unable to be objective about the study.
If you have questions for the committee, please contact Tera Jarvis (email@example.com)