Parexel Biotech

Parexel Biotech Chat Transcript Title

Monica Theis: I really like being out in nature, ideally with my kids because they're just my little gems, but probably anywhere but in a doctor's office.

Amy McKee: Did you work full time through your first trial?

Monica Theis: Yeah.

Amy McKee: You have a family. It's amazing.

Monica Theis: You do what you got to do sometimes and that's what I have to do. My first clinical trial would have been with my stage four breast cancer diagnosis. That would have been probably about a year ago or so, but that one failed rather quickly.

Amy McKee: Then you moved to a second trial.

Monica Theis: Yes. That was where I had a choice between starting a pretty aggressive chemotherapy, which I wasn't very excited about or looking for something else. We were able to find a trial that I was able to qualify for.

Rosamund Round: Do we make easy enough for patients?

Monica Theis: No. When I think of elderly or English as a second language, I don't know that they would even know to find trials. It's just a lot of information to sort through.

Amy McKee: Has it been challenging for you, the eligibility criteria?

Monica Theis: Yeah, it's frustrating because for a lot of them, I've either had too much treatment in my life that I don't qualify or I haven't had enough treatment of other kinds to qualify. It's a long, frustrating process when you're just wanting to get started with the drugs and your treatment.

Amy McKee: My role now that I work at PAREXEL is I help advise companies on how to use the programs at FDA and other agencies to speed up the development of really great drugs. I'll say, "Do you really need that eligibility criteria Because I think you'll lose a pretty big swath of patients? You don't need it for this trial."

Monica Theis: Interesting.

Monica Theis: One thing that's really nice about trials is the medication's covered and, oftentimes, your scans and your doctor's visits are too. That is a Godsend. I can't imagine for people that are struggling to pay for their medical bills.

Amy McKee: How about something you didn't love about being in a clinical trial?

Monica Theis: I have to drive about an hour and a half for my trial. Some of these appointments are at 7:00 in the morning, so do you do a hotel and you stay overnight, which that's not covered, or do you just get up at 4:30 and leave? If you were a hourly wage earner or something, that would be a huge burden.

Rosamund Round: It sounds like it's often the practicalities around the treatment that can be just as challenging because I know we do things that we can provide transportation services. I don't know if you know much about virtual trials and telemedicine, but in certain-

Monica Theis: A little bit.

Rosamund Round: ... situations where we can take all or some of the trial to the patient in their home, so using things like delivering the medication to you directly and sending in-home nurses for blood draws and using telemedicine. You can have video calls with your physician, so you don't necessarily have to travel every time.

Amy McKee: Do you think there are times where you would have appreciated a virtual visit instead of having to go into the clinic?

Monica Theis: If I'm just going in for a blood draw and you honestly see the doctor just to go through, these are what your results are and so let's hand you the medication, there's no reason that that needs to be an in-person appointment.

Monica Theis: I can say that over the 27 years of treatment that I've had, I've seen so many innovations, both on the medical side and the treatment side. I guess I'm curious as to how far forward do you see things going? Where are some of the big changes coming?

Amy McKee: I don't think patients have been invited in the way we want to invite them in now to participate in drug development because that's a huge shift. And I think it's really important because I think it'll make smarter drug development.

Monica Theis: Absolutely. We're the ones with the information.

Amy McKee: Yep. You're you're the primary source. How can we not use that?

Monica Theis: You're on our team and we want you on our team and so...

Monica Theis: I had read this book a while ago and I don't remember the name of it. One of the things that was in there talked about hope. There's hope and then there's healthy hope. Healthy hope is described as being hopeful for something that can actually happen. For me, healthy hope is all these advancements in medical care because my healthy hope is to stay alive for a really long time. That's when I start to cry. I do believe it's possible because of the advancements and all of the great stuff that's happening. That brings me a ton of hope.