Business Continuity Plan for COVID-19 Outbreak

As a company dedicated to being a trusted partner in creating a world of safer drugs, Spaulding Clinical Research is following recommended clinical trial and workplace strategies outlined by the FDA, Centers for Disease Control and Prevention (CDC), as well as state and local health authorities to safeguard against COVID-19. 

The following actions have been taken to maintain the safety of our employees and study participants:

·      Thorough phone screening of study participants to prevent symptomatic participants from entering the clinic

o   Phone screen script developed to screen out people with the highest risk of infection

o   Notice to all employees and participants with appointments to not present to clinic if they have any pre-specified symptoms

·      All staff, vendors, monitors, and study participants entering the clinic will complete a triage process which includes temperature screening and a questionnaire on travel, contacts, signs, and symptoms

·      Enhanced social distancing for participants and employees during all study activity

o   Beds more than six feet apart

o   Community areas set up to assist in distancing: lines placed on floors in waiting areas, additional waiting areas opened, common areas reconfigured to allow greater distancing

o   Clinical staff will work remotely when able; all office staff will work remotely with a slow return to the office in small groups over a 1–2 month period, following state and national guidance

·      Designated building spaces for confined versus non-confined participants; participants checking in for confinement will flow through separated areas from participants coming in and out for screening and outpatient visits

o   Isolation rooms set up to segregate participants that develop any symptoms of concern while housed in the unit

o   Designated staff for confined participants versus non-confined participants

·      Enhanced disinfecting measures have been put in place specifically for COVID-19

o   Additional cleaning procedures for staff at work sites, equipment, etc. (increased frequency to decrease risk of spreading infection)

·      Hand sanitation stations added to key locations; this will not replace, but be in addition to, our current handwashing policies

·      Personal protective equipment requirements

o   All staff and participants to wear surgical masks when within six feet of each other during all study activity

o   Masks, gloves, goggles, and gown to be worn during triage procedures

o   Glove use will continue per our bloodborne pathogen training and policies which require glove changes between every participant

·      Testing for COVID-19 will be done, if deemed necessary, for suspected cases of COVID-19 through Quest Diagnostics

o   This applies to anyone who is in confinement that exhibits symptoms of COVID-19. After moving to isolation, the investigator may elect to send a nasal swab sample to Quest Diagnostics. A supply of swabs have been reserved for these scenarios.

·      Only healthy populations will be considered for screening and enrollment at this time; all immunosuppressant trials, and those requiring renal or hepatic impaired subjects or elderly participants, have been suspended until further notice

·      Bed occupancy in the 200-bed campus will be significantly limited in May 2020 to allow for social distancing measures

·      Screening and check-in groups will be limited to 10 participants at a time to allow for six feet of distance to be kept during this process

·      Spaulding Clinical is currently exempt from the State of Wisconsin Safer at Home Order since it is classified as an essential business; the unit will continue to operate with the implemented safety precautions as described above

 

The Challenges of COVID-19 Testing

Much focus in the news has been placed on treatments and vaccines for COVID-19 — and rightly so. This pandemic has created the greatest worldwide disruption of modern life in recent history. But in order for trials to continue safely now — and new trials to begin in the future — the availability, accessibility, and accuracy of COVID-19 tests need to be carefully considered.

COVID-19 testing is critical to the reopening of our economy and a successful return to safe clinical research. Many precautions have been put in place, such as personal protective equipment, social distancing, symptom checking, increased disinfection procedures, and commitment to ensuring at-risk populations are not participating in Phase I trials at this time. But COVID-19 testing is the piece that will allow us to resume trials with confidence and low risk.

Testing has suffered two main limitations: accuracy and supply chain.

Testing Landscape

Here at Spaulding, we’re committed to researching the tests and implementing them in the most logical way possible. The available COVID-19 tests, when combined the right way, provide a lot of information and the ability to rule out infection when a patient is admitted to a study. But an understanding of the benefits and limitations of each test needs to be weighed carefully.

  • Molecular PCR test— This test demonstrates the presence of proteins unique to COVID-19 that are detectable early on in infection when the virus is actively replicating. It is the gold standard for confirmation of COVID-19 cases. Detection of the viral RNA is only possible when someone is actively infected.
    • The FDA has given Emergency Use Authorization to 37 of these tests for Moderate to High Complexity laboratories. Limitations to these tests in the Phase I trial environment are supply, cost, and timing of results. Nasopharyngeal swabs are required for specimen collection and, as everyone reading the news has heard, they are in short supply. However, searching outside typical supply chain routes, the swabs can be found, and their availability increases weekly. Test cost can range from $150–$250. This is feasible for confirmation of suspected cases, but is not the best choice for testing at screening and again at check-in to a trial. Finally, timing is anywhere from one hour to two days if a send-out. Rapid results are more ideal for screening procedures.
    • Three tests have received Emergency Use Authorization for CLIA-waived point of care testing. These tests are ideal for Phase I screening due to rapid turnaround time of 15–30 minutes and low cost. However, these tests are currently in high demand and short supply. These may be a great option in the next 1–2 months, but are currently not available.
  • Serology test — Antibody tests show the presence of antibodies in the blood responding to a COVID-19 infection. IgM antibodies demonstrate infection earlier than IgG. Antibody titers begin to rise three days after infection, with an acute response in seven to 14 days. IgG antibodies can be detected 14 days after initial infection, in some tests with 100% sensitivity. This antibody test is very important, not only for clinical research, but for community monitoring. It can tell us if a participant has already had the infection and has developed an immune response.
    • Antibody tests are quite accessible for Phase I trial sites with an on-site clinical laboratory. Many of the analyzers used for HIV and hepatitis serology testing in clinical trials can be updated to acquire one of the newly developed COVID-19 antibody tests and cost is not prohibitive.
    • This is a great test for employees as they are returning from remote work and to monitor the ongoing health of employees. It also should be considered for the monitoring of participants throughout the duration of a trial.
    • The limitation of this test is that it does not detect COVID-19 in early onset.
    • There are currently many point of care antibody tests available at a low price that have not received emergency use authorization. It is important to research the accuracy of these tests before implementing, especially given the lack of traditional methods of FDA approval. Given the lack of point of care tests available, finding a manufacturer of these tests with a quality reputation and good quality control documentation may be an alternative option that needs to be considered.

Proceeding With Caution

The ideal testing for Phase I clinical trials is a combination of the above tests. Most Phase I sites have set up an isolated triage environment before admission to screening or a waiting area. This currently includes a temperature check and symptom review, and would be the ideal setting for a point of care rapid antibody test. Any positive result would be confirmed by molecular testing and the participant sent home for at least two weeks before being retested. Any symptomatic participants or suspected cases would not proceed to check-in.

At check-in for confinement, the screening procedures would be repeated. A PCR test at check-in is the most ideal. IgM antibody tests could be repeated at Day Four of confinement to ensure infection is not developing. If a participant develops symptoms during confinement, they would be isolated and monitored, and a PCR test performed.

We all know this pandemic is rapidly evolving, and what may look like the best testing method today could be largely different in the future. With the goal of conducting our trials in the safest way possible as well as serving our customers and the very important drugs they are developing, it is imperative to establish a testing method that will give all of us the confidence to safely move forward.

Cassandra Erato
CEO
Spaulding Clinical Research

Spaulding Clinical Research Awarded Five-Year Contract With FDA

West Bend, Wis., February 27, 2020Spaulding Clinical Research today announced that it has been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest. They have kicked off this agreement with $5 million of clinical trial work to be run in 2020. Spaulding Clinical is responsible for conducting the trials and providing the necessary support services including clinical trial recruitment, conduct, and laboratory assessments.

The objectives of each trial vary considerably among different therapeutic areas, but all address important regulatory science questions in today’s pharmaceutical market.

“We are happy to partner with the FDA to help address agency questions about various classes of drugs. Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need,” said Cassandra Erato, CEO at Spaulding Clinical Research.

Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years. “We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT. Through this work and resulting publications, we have developed a productive partnership,” said Dr. Jay Mason, chief medical officer at Spaulding Clinical Research.

About Spaulding Clinical Research

Spaulding Clinical opened in 2008 and was built upon fully electronic data and integrated, purposefully engineered systems for conducting Phase 1 trials. Spaulding runs a 200-bed facility in West Bend, Wisconsin, and conducts and analyzes First-in-Human, clinical Proof-of-Concept, cardiovascular safety (TQT, concentration effect), and NDA-enabling clinical pharmacology studies. Spaulding Clinical provides expertise on study design, medical writing, clinical data management, biostatistics, and PK/PD analysis. Learn more at spauldingclinical.com.

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