Since March, many clinical trials in the United States have been forced to halt procedures due to the novel coronavirus outbreak. If you’re thinking about participating in a clinical trial in the next few weeks or months, you might wonder, “Are clinical trials safe during the COVID-19 pandemic?” To ease your fears, we encourage you to explore the safety measures that clinical research organizations (CROs) are putting in place to safeguard their employees and trial participants. To ensure that promising therapies are still able to move forward in this uncertain time, CROs are adapting their standard processes, technologies, and training. It may be challenging, but it’s certainly not impossible to continue conducting clinical trials through a pandemic.
Are Clinical Trials Safe During the COVID-19 Outbreak?
The answer to this question depends heavily on the clinical research organization performing the trials. So if you’re exploring the possibility of participating in a clinical trial, you need to learn how that specific clinical site is adapting its protocols. Explore how the site is changing employee procedures, facility sanitation, and trial routines. If you have any questions, don’t hesitate to contact the trial coordinator for more information. You deserve to have complete peace of mind regarding your health and safety before you agree to take part in a clinical trial.
In addition, the Food and Drug Administration (FDA) is exploring alternative approaches to maintain participants’ health and safety during clinical trials, For example, some clinics may be able to use telemedicine and virtual visits to reduce participants’ risk of contracting the novel coronavirus. Or you may be able to provide some information over the phone.
How QPS Is Adapting Its Procedures
So how is QPS altering its procedures in the face of the novel coronavirus?
Each clinic is following the recommendations of all applicable international, national, and local health authorities. We will review and update our strategies periodically to ensure that our procedures are up to date and reflect the most current recommendations. Furthermore, our team is working closely with each sponsor on a case-by-case basis to determine the best way to maintain participant and staff safety while achieving the objectives of each study. We are fully prepared to make the necessary changes to our clinical trial sites to ensure the protection of our participants and employees.
The QPS clinic in Springfield, Missouri, is currently ready to resume study activities. To explain the details, let’s review some FAQ.
How will QPS screen potential study participants?
Off-Site Telephone Screenings
Before we invite potential study participants to visit our site, we will screen them over the phone using a questionnaire approved by the Institutional Review Board (IRB). As always, we will ask potential participants about their current health. However, in light of the COVID-19 pandemic, we will now also be asking potential participants questions regarding COVID-19 symptoms, their recent contacts, and their travel history. If we identify someone as a risk, we will not invite that person to visit our clinics until their health has been cleared via a health care professional.
During on-site screenings, study participants must observe all applicable social distancing guidelines, including wearing a face mask (which will be provided by QPS) and staying at least six feet away from other study participants. All screening activities will be conducted in designated areas, and each potential participant will be treated as if they are infected with the coronavirus. Upon arrival, each participant will undergo a temperature check and complete a questionnaire to determine if they are exhibiting any symptoms of COVID-19. If deemed necessary, the participant will be tested for COVID-19 (see below).
The Informed Consent Form (ICF) will be explained to each participant via video or in person, as decided by the site. Participants will only spend time “live” with QPS staff members when asking questions and signing the ICF, and even during that procedure, the subject and staff member will stay at least six feet apart.
Will QPS be testing participants in upcoming clinical trials for COVID-19?
Yes. If deemed necessary, QPS will test new study participants using polymerase chain reaction (PCR) testing. Whether you have symptoms of COVID-19 or not, this test can identify the presence of an active novel coronavirus infection. PCR testing is the most accurate and reliable option available, and QPS has developed its own PCR test to ensure quick turnaround times for results. Testing procedures will occur in designated locations, away from the clinic used for active study participants. Although the turnaround time for results varies by clinic and location, it is expected to be 48 hours or less. At QPS Missouri, we have a contract with a local lab to ensure same-day turnaround of testing results.
What other procedures are changing at the QPS Missouri clinic to ensure participant safety?
- QPS staff members will wear personal protective equipment (PPE) while on site and follow all applicable local guidelines when not at the clinic.
- Participants must observe all applicable social distancing guidelines, including maintaining a distance of at least six feet from other participants and staff members.
- Participants must wear a face mask, which will be provided by QPS.
- Screenings will take place on an individual basis.
- Screening areas will be cleaned between potential participants.
- QPS will ensure there is at least six feet between beds, chairs, etc. to ensure social distancing of participants.
- All efforts will be made to limit contact between QPS staff and participants.
- The QPS clinic will maintain a strict cleaning policy.
- Hand sanitation will be encouraged upon entering the clinic.
Are clinical trials safe right now? Yes, but if you’re considering participating in a trial, contact your clinical trial site to learn more about the changes being made to protect you from the novel coronavirus. If you have questions or concerns about the safety protocols in place at your clinic site, speak with the trial coordinator to put your fears to rest.
Have you ever thought about participating in a clinical trial? QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. If you would like to join us in this mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.