Clinical trials are an essential part of developing drugs that combat disease. The effort to end the COVID-19 pandemic is no exception. PatientWing, a CIC Philadelphia member company with the mission of connecting patients with clinical trials, has launched a new website to increase enrollment in COVID-19 related ones.
“Due to the large number of studies and volunteers needed, it is critical that we educate and help patients and volunteers find and enroll in appropriate studies,” said PatientWing cofounder and CEO Zikria Syed in a press release. ”We are also providing our patient onboarding and enrollment tools to research sites at no cost.”
We grabbed some time to talk with Stephen Worley, Director of Marketing at PatientWing, who had much to say about the critical need for clinical trials. Here he explains how PatientWing has adapted what they already do in the fields of rare diseases and oncological studies into an action plan for COVID-19 clinical trials.
CIC: First off, why don’t you tell us a bit about PatientWing and the work that you do?
Stephen Worley: Our mission is to connect patients with the correct clinical trials to advance science that saves lives. We work with sponsors (research entities running clinical trials), and we have two products that we offer them. One is an active recruitment that we call Enroll Powered by PatientWing. We work with our sponsors to advertise their clinical trials and bring patients all the way through to enrollment. We develop communication tools with sponsors, which includes a call center while keeping the patient in mind. We get that patient interested but also retain them in the long run during and after the clinical trials, because in rare disease space, where there may only be a few thousand patients in the entire population, engagement is highly valuable.
So say you have 100 patients apply for your study and only five enroll; what happens to the other 95? In your next trial, why start from scratch when you already have 95 potentially eligible patients who are eager to participate? Additionally, it helps with commercialization. Say you develop a drug or treatment that goes to market. Well, if you keep engaging with your patients post trial and keep that relationship alive, then you have your exact target audience for your drug or treatment just entering the market.
We have a second product called Engage that’s a fully branded website that allows sponsors to engage with patients before, during, and after clinical trials.
What’s unique is this industry really hasn’t understood that sponsors could engage with patients. There hasn’t been a HIPPA-compliant way of doing it. Because of patient privacy, sponsors aren’t allowed to know who their patients are during clinical trials. By anonymizing the data, we’re providing aggregated data. The sponsors can send out email blasts to those patients without knowing who those patients are. And we focus more on the rare disease and oncology space, where patient populations are really small and they’re spread across the entire world. So if you’re looking for 1,000 patients worldwide, the value of a patient is so much more. You need to engage them earlier; you need to provide them the contact; you need to stick with them. Because if you lose them, that’s one out of a thousand, not one out of a million.
CIC: How do you see the work that PatientWing does in the broader healthcare landscape?
We’re in the R&D stage. When it comes to treatments drugs and medicine, we’re on the pharmaceutical side of that. We believe that clinical trials are the only way to develop effective treatments — or life-saving treatments, in some cases. A lot of patients we included don’t know about clinical trials. I didn’t know about clinical trials until I started this job. Only about 10% of Americans know what clinical trials are, yet clinical trials have to happen. If you think of the Advil we take, for example: clinical trials had to happen for that Advil to be on the counter, but many people don’t know what that means. Part of what we do is just educating people on what clinical trials are and how they are important.
CIC: Explain this new website and how the nature of the COVID-19 pandemic has changed your approach to the work that you do.
SW: As you know at CIC, COVID-19 has impacted nearly every business across the world. As we are in the healthcare industry and COVID-19 is a disease, we wanted to make an impact right now without focusing on generating revenue. We realized that even though there are hundreds of thousands of coronavirus cases, pharmaceutical companies that are developing these clinical trials for life-saving treatments can’t find patients for them. Hospitals can’t just give up patient information due to privacy laws. Also, the general public doesn’t actually know how to relate to clinical trials, even though they’re one of the only viable ways for COVID-19 to end. So we dug into it a little bit and decided to list all the COVID-19 trials in a very user-friendly way so people can quickly see what they are eligible for, while educating them about what clinical trials are.
CIC: What would you say to a layperson who is nervous about the prospect of participating in a COVID-19 trial? What is your vetting process for studies? What kind of safeguards are there? What are the risks?
SW: I would say for them to make sure they understand the two main types of clinical trial: interventional studies and observational studies. Interventional studies are the ones where there’s an investigational drug or treatment, so they’re going to be ingesting or somehow taking that treatment. Those are the ones we hear about all the time in the media.
Then there are observational studies that have no active treatment. Researchers are simply observing the current state of a condition. There are a lot of clinical trials that are apps where patients can record their daily symptoms with monitoring, so they might have interviews like the one we’re having right now but with researchers.
I would say that if somebody is nervous about ingesting a new medicine, observational studies are a great way to participate. They don’t have to leave their couch. Researchers [for interventional studies] will break it down — how many visits are needed, if patients need to be hospitalized or if they can be healthy, if they need to have had COVID-19, what exact drug they’re going to take, the exact dosage, and how often.
These studies are all assessed by the FDA prior, and they have to clear the clinical trial for it to start. There are always inherent risks because it’s experimental. But the doses are usually low until they can determine the efficacy and safety of the trials and the drug itself.
The best part about it is when you sign up to register for a clinical trial, there’s an informed consent form (ICF) where the researcher is going to walk through the entire trial, and you will sign at the bottom that you understand every aspect of the trial. If you don’t, that’s the time to ask questions.
CIC: So that’s industry standard, any sponsor who goes through PatientWing would have to have all their ducks in a row?
SW: Exactly. There’s a national database at clinicaltrials.gov. In order to have a clinical trial, you must post on this registry. We sync with that and use APIs to bring in that list. It’s a heavily regulated, heavily specific industry, so our ducks are always in a row.
CIC: Is there anything else you would like to highlight about PatientWing’s COVID-19 clinical studies site?
SW: You can follow the PatientWing blog for content; we’re trying to post more regularly. I just posted one about vaccine trials and why they matter. There’s one coming up on the top five virtual studies for people who are sitting on their couch and want to make a difference.
To learn more about PatientWing’s COVID-19 clinical trials, please go to PatientWing’s dedicated site.
For the latest on CIC’s response to the COVID-19 pandemic, go here.