COVID impact on Clinical Trials

Dear Clinical Research Teams,

As you all are aware, the demand for hospital care and services has markedly increased in the past few weeks. We have more COVID patients in our hospitals than we had in our fall surge. IU Health is currently caring for 518 COVID-19 patients throughout the system. This is an all-time high number of COVID patients at IU Health.

• There are 496 patients in ICU-level care, and 339 of those are COVID-19 patients.
• IU Health has added beds in additional spaces for patients needing ICU-level care.
• The number of ICU bed numbers at a hospital can change over time as non-ICU beds can be turned into ICU beds with the right staff and equipment.

More hospitals across the state are on diversion. The coupled diversions and increased local cases and demand is really straining inpatient teams. IU Health is stretching into any care space available downtown and asking our teams to stretch to accommodate. Starting next week, IU Health is canceling outpatient elective surgeries and evaluating cases that require inpatient resources that can safely be delayed another few weeks, in addition to the elective inpatient cases that have already been deferred. All areas are being evaluated for the opportunity to reschedule care to help redeploy staff and services to where it is most urgently needed. IU Health has secured national guard support for several hospitals and is in the process of securing FEMA clinical resources to help reduce the team burden and has asked the investigational drug team to help support the inpatient pharmacy team in whatever capacity they can. Despite all of this, the COVID demand is still expected to increase these next two weeks and peak in late December/early January. Decisions to defer programs or care are not taken lightly, but the pharmacy services are experiencing significant operational hardships.

In the context of the COVID surge and the pressing demands of caring for patients IU School of Medicine is assisting our IU Health partners by carefully evaluating and modulating clinical research requirements.

To help continue clinical research while accommodating needs for beds, inpatient services, and Investigational Drug Service (IDS), the following plan has been outlined and is being implemented:

• Pause all NEW recruits into existing studies and all NEW studies that require IDS or inpatient beds, or major hospital services (for example, radiology, etc.) that are needed while the hospital is FULL.
• Continue all COVID trials and any trials with potentially life-saving therapies (for example, cancer therapeutic trials).
• The anticipated resumption of inpatient trials is January 10th, but subject to change (pending reduction in strain on hospital capacity).
• This plan does NOT impact basic laboratory research.

Please contact Sharon Moe, Deb Broach or Laurie Trevino with questions.

 

Tatiana Foroud, PhD

Executive Associate Dean for Research Affairs, Indiana University School of Medicine Executive Vice President of Academic Affairs for Clinical Research, IU Health