CISCRP Partners with SubjectWell on Survey

Race and Gender Play Role in Patient Views About Clinical Research During COVID-19 Pandemic

CISCRP partnered with SubjectWell, a patient recruitment firm, polling 553 patients in the United States to review how race and gender impact clinical trial participation, during the COVID-19 pandemic.

Respondents report concerns about being exposed to COVID-19 if enrolled in a clinical trial. By gender, the survey found that men are less hesitant to participate in non-COVID-19 than women. Women place higher values on precautions such as being able to communicate with a study physician remotely. African American patients are more concerned with precautionary measures like limiting the number of site visits and having the ability to send lab samples from home compared to Caucasian patients.

Review the results of the survey on Subjectwell’s website and in an article published on PM360.

For information about collaborating with CISCRP on research initiatives, contact Annick de Bruin, Senior Director, Research Services, at 617-725-2750, extension 400 or at adebruin@ciscrp.org.

 

 

 

 

Medical Hero Story: Nurse Katie Klatt & COVID-19

At the beginning of the pandemic in mid-March, Katie Klatt, a nurse on a COVID-19 infection control team, received the news that she had contracted the virus herself. “I wasn’t too surprised,” Katie said. “I kind of knew, but the actual confirmation was a little bit scary. It was early on so no one in the US really understood how bad it was.” A healthcare professional, Katie’s background includes working as a PICU nurse and she had just moved to Boston to pursue her Master in Public Health at the Harvard Chan School. Now fully recovered, Katie is a patient participant in a COVID-19 antibody clinical study. This is her story.

Katie contacted her primary care physician when she started having symptoms. “I was treated in two different ways. The first week I was seen via telehealth, and that was literally the same week that so many medical professionals and patients were turning to that option. My doctor was retiring, so I didn’t really have anyone following me. The onus was on me to check in and report my symptoms.” At the end of the first week, Katie was advised to be seen in person, at an urgent care clinic. However, being symptomatic, she could only be seen at the urgent care if she was a previous patient. Being new to the area, this was not the case. Her only other option was to go to an emergency room.

“At first, I didn’t think I was sick enough to go to the ER. I didn’t want to take an Uber and infect anyone else and I was too tired to ride my bike. So I waited until the Tylenol kicked in and walked 40 minutes to the hospital. At the emergency room, they were really well set up. When I walked in, people started to call ‘Rule out!’ which means a COVID-19 patient is entering the area, so people started to move away from me as I passed by. After I was seen, Security escorted me out the back door to protect other patients and staff,” Katie said.

The hospital pharmacy was closed, so Katie was handed a paper prescription to have filled elsewhere. Even though she was wearing a N-95 mask her mother had sent to her a few weeks before she got sick, Katie realized that she should not enter a store. She was also concerned about handing the paper prescription to a pharmacy technician. Katie called a friend who met her at the pharmacy with a clear plastic sandwich bag. She dropped the prescription in it and her friend brought it inside and had it filled.

In addition to having COVID-19, Katie also had a sinus infection. When she was diagnosed, Katie knew what to do. “Stay at home, isolate, hydrate and rest,” Katie stated plainly. “As a healthcare provider, we tend to minimize our own complaints because we’ve seen so much worse, so my view of it was skewed. Having a 103 degree temperature for 10 days, it was almost like I got used to having the chills and feeling exhausted constantly.”

Katie socially isolated from her roommates, staying in her room and only entering the kitchen when they were not present. “I had the presence of mind, despite the high fever, to clean everything I touched – that’s from my nursing background. I’m happy to say my roommates didn’t get the virus.” Family and friends sent care packages and checked in with phone calls and texts which helped buoy Katie’s spirits.

A few days after starting medication, Katie began to rapidly recover. She attributes this, in part, to being a lifelong athlete, playing in Australian and Gaelic football leagues. “When I got COVID-19, I lost about 10 pounds in a week and I lost a lot of my fitness. When my taste started to come back, I was able to eat more and work towards regaining my fitness.”

Katie is using her experience with COVID-19 to assist others. “A friend of mine who is a nurse told me about a clinical study, so I registered for it. The purpose of the study is to monitor levels of COVID-19 antibodies present to see how long they last in a recovered patient’s body. It’s a two-year commitment.”  On a monthly basis, Katie’s blood is drawn and analyzed. Currently, she has not been notified of recent results and she hopes to be informed soon.

In her role as a nurse on the COVID-19 infection control team at Boston Emergency Medical Services, Katie shares her story with EMTs and paramedics who have been exposed to or have contracted the virus while treating and transporting patients. “This is an isolating disease,” Katie explained. “Not having a stigma attached to it is important. It helps them when I explain what I went through when I was sick.”

When asked if she is concerned about contracting COVID-19 again, Katie said “I probably should be. I have reached the same fatigue that everyone in the world has now, around COVID-19. It’s hard to maintain that level of high alert. But I am being careful, more for others than for myself. I wear a mask everywhere, even when I am running outside. I do it because I don’t want anyone else to get it.”

Katie cautions others to be just as vigilant. “Just because we’re opening up, it’s not over. Wear a mask to protect yourself and others. Keep talking about it so that people don’t forget.”

 

A Look at COVID-19 Vaccines and Treatments

You’ve probably heard a lot in the news lately about the development of vaccines and treatments for COVID-19. But what exactly will these treatments look like and what are researchers doing to discover them?

Researchers are testing a number of approaches in clinical trials that involve introducing a weakened or inactive form of the virus into the body to prompt an immune response without causing harmful disease. If the body reacts as desired by creating antibodies to attack the virus, then it may build protection against future infection. Vaccines like this have been successfully developed to prevent many diseases like measles, mumps, rubella, smallpox, and chickenpox. Other vaccines under investigation, such as genetically engineered DNA or mRNA vaccines, try to trick the coronavirus into mutating into a form the body can more easily and effectively attack. Another category of vaccines are those intended to block the virus from attaching to healthy cells in the body and reproducing to cause widespread infection.

 As researchers work to uncover an effective vaccine for prevention, they are also testing treatments in specific patient populations that are already infected with COVID-19. These treatments look to lessen the severity of symptoms and shorten recovery times. Some treatments currently in development seek to moderate the body’s own immune response to the virus.

The necessary steps

 Vaccines and treatments for infectious diseases usually take nine or 10 years to develop, and most will fail to complete the process or obtain regulatory approval. This seems like a long time, but it is necessary for understanding the real effects of a new therapy and determining whether it is safe and effective at specific dosage levels.

Clinical trials follow a set progression: They begin with a small number of people to assess whether a treatment is safe, then grow to further evaluate safety and efficacy. At each stage of this progression, researchers review the results of clinical trials and get approval to move on to a subsequent stage.

Accelerating the process

The clinical trial process for COVID-19 treatments and vaccines is moving at a faster pace and may produce promising therapies within a few years. The pandemic has mobilized much higher levels of coordination between companies and government agencies. Some treatments and vaccines have a head start because they are based on research that was conducted for viruses that are similar to COVID-19.

Fast-tracked treatments and vaccines in clinical trials have received a lot of attention in the news. They include Moderna’s vaccine (mRNA1273), Gilead Sciences’ treatment (remdesivir), Regeneron and Sanofi’s Kevzara treatment (sarilumab), and the antimalarial drugs hydroxychloroquine and chloroquine.

In some instances, for the most promising treatments and vaccine candidates, the Food and Drug Administration (FDA) may issue an emergency-use provision so patients, doctors, nurses, and other essential workers can begin using it. Under emergency-use conditions, even more information about a new vaccine or treatment will be used to inform researchers and the FDA about safety and efficacy.

Perceptions & Insights: COVID-19 Survey of April 2020

Given the recent increase in attention to the topic of clinical research in the wake of the COVID-19 pandemic, CISCRP conducted a brief survey to assess what impact the pandemic has had on levels of understanding, perceptions, and experiences related to clinical research. This report outlines key findings from this survey. Where appropriate, CISCRP draws comparisons between this brief survey and the 2019 Perceptions and Insights Study (a large-scale global survey on public and patient perceptions of clinical research).

Download the survey here.