By Crista Brawley
People don’t always realize that clinical research trials are very interactive, and there’s a lot of individual patient care that goes on with clinical research as well. You need someone who’s willing to share with you all the details of how their body is responding to help us understand the up and downsides of what they’re going through. It’s a very personal experience.
When a patient came to Rush for a second opinion on her metastatic breast cancer, the team let her know there were many options to manage her cancer, including ones in clinical research. We asked if she would be willing to learn about some of these studies we had to offer.
She was excited about being in a clinical trial, and that enthusiasm is great for us as a team. She wanted to closely follow the protocol, listen and learn about her care.
She provided researchers a lot of key information, such as letting us know, “Hey, this is what happened to me today, and you guys should know about this.” That level of involvement and feedback lets us see what we need to change in the trial or to look at while adjusting her medication.
Clinical trials are moving in an exciting direction: We’re doing studies now with drugs that are approved by the Food and Drug Administration for a certain cancer group, and we’re able to try them in a research setting for another disease area. These types of trials are providing a lot of hope and new opportunities for people.
Another thing is that cancer can be very sneaky. You might have a diagnosis of cancer and start on a therapy that works for a short amount of time. Then the cancer gets smart and starts to replicate in a different way or mutate to a different form of cancer so it can evade that treatment. That’s when we, as a team, have to talk about a new therapy to treat this now new form of the cancer.
And, that’s sometimes when clinical research can help because we’re testing new options. We can work with a patient’s doctors to look at previous therapies and say to a patient, “You might not have responded well to this standard therapy, but what about this other therapy? Or what if we’ve tweaked the therapy and see if you respond better?”
‘No typical response on a clinical trial’
There’s no typical response on a clinical trial. That’s why we’re doing the research because we don’t know how patients are going to respond. We hope everyone does really well. And luckily, we have a lot of cases where patients do respond really well, in part because there’s a lot of research that happens prior to the trial.
Often it takes a while to see the effects of how things are going. But with Margaret, we knew we were on the right track early on, which was fantastic to see.
And that’s the tricky part: There’s no guarantee in clinical research that this therapy is going to have any effect on the person in front of you. Participating in a trial is an altruistic gesture. There are cases where the therapy doesn’t work for an individual patient or for a group of patients. But what we learn from that trial can help with future new drug development or for future patients that come in. So the data’s never lost.
‘Best for the patient’
What is great about working at Rush is the drive to do what is best for the patient. For instance, clinical trials are baked into the clinical care process. We’re sitting at the table when patient cases are initially being discussed so that we’re able to present our thoughts on available clinical trials as part of the treatment planning process.
We had one case in which we needed a clinical trial for a patient, a young mother who was in a coma. We didn’t have a trial here at Rush that fit her cancer profile. But we found a trial with a sponsor in Italy, and we were able to work with the sponsor to bring that trial to our patient within a week. We learned about the patient on a Friday. We had all the information to open the trial here by Monday. We got all the approvals we needed in days, and we were treating the patient that following Friday.
That doesn’t often happen in the real world, but it does here at Rush because everyone’s on board. Everybody wants to do what’s best for the patient. That’s why I think doing clinical research at Rush is so exciting and why I love my job.
Crista Brawley is associate vice president for research regulatory operations at Rush.