Quintiles Employee Finds Cure in Clinical Trial

As a baby, Tess Brennan received two blood transfusions, and after 20 years of symptoms she’d experienced on and off, it was finally discovered she had the Hepatitis C virus. After that, she actively looked for a clinical trial, and was fortunate to find a Phase II open-label trial with four treatment arms for which she met the protocol criteria, at the local Duke University Hospital. She signed the consent form and then asked if the trial was being administered by a CRO. She received the answer…it was, and Quintiles, her employer, was the CRO.

The full background on Tess’s experience is written here, along with a video on Quintiles web site. Applied Clinical Trials wanted to know if Tess had any thoughts or recommendations around clinical trials after being a participant. Below are Tess’s experiences with her trial.

Q: What were the positives of the trial?
A: First and foremost, the study coordinators and phlebotomists were the people I saw the most frequently and they made me feel like family. From the moment I set foot in the research clinic I felt like I was their priority, their special patient. I was not treated like a “number” or someone with an infectious disease.
My favorite memory of this entire experience is when I was told my viral load went down from 10.5 million to 47.

When I burst out crying with the good news, each one of them teared up too. It was a very emotional day for me, and it was clear that they were “rooting” for me to get healthy.  They shared with me that they cried for patients, in other studies, who didn’t have success, or who didn’t “make it” back to the clinic.

They do what they do because they care. I had intellectually understood that, having met many of them throughout my career. However, I was able to experience that from the patient perspective, and it was truly awesome. It made me realize that it is the research staff, not just the study drug, who are the keys to successful patient retention. Yes, I wanted to get well, but being in an open and caring environment made a world of difference when you trying to get well.

Q: What concerned you as a research participant?
A: It has to do with vulnerability. I feel compelled to note that I had support both at home and at work regarding my study participation. I disclosed my illness to my line manager as well as my decision to go into a clinical trial. I received a lot of support at work. I attended my research appointments as needed. I blocked my calendar; let staff know I would be out of the office and came and went as I needed to. I did my work, met my timelines and did what was expected of me at my job in spite of being a study participant—and life just kind of “went on.”

However, it did occur to me, “Was this everyone’s experience who entered into a research trial, trying to get well or find a cure for what ails them?” I was forced to wonder, “Was it because I worked for an organization such as Quintiles that my study participation was accepted?”

What about those people who were sick and afraid to tell their line managers?

Were they provided with the same level of dignity, respect, and flexibility that I was provided as an employee of Quintiles? While my heart wants the answer to be a resounding, “Yes, of course!” my intellect tells me that may not be the case.

That is what drove me to tell my story, to talk openly about my illness, my experience, and how being embraced in the work environment is a crucial piece to being a research study participant.

Q: Often we hear that the long informed consent form is a barrier to participation or the protocols are too difficult for patients. What was your experience?
A: The ICF was very thorough and was more than 20 pages long.  It could have been 100 pages, and I wouldn’t have cared. I was just so excited and hopeful to be screening for a clinical trial. The ICF was very clear about potential side effects, that the drugs could possibly not work, and also detailed the study procedures. It was very thorough and I found myself relieved that it was.  I wanted it to be thorough. I wanted the study coordinator to take her time and answer my questions. 

With 20 years of experience in clinical research, I was watching the study staff with a very critical eye.  I quickly found there was no need to be watchful because I was dealing with a well-trained and extremely professional staff at Duke GI Research, so it was easier for me to just be a patient vs. a clinical researcher and a patient.

My initial visits were quite lengthy, but to be honest, I didn’t mind. The research staff kept me well informed of how long each visit would be, what I could expect during the next visit etc., so I was always prepared. There were a lot of blood samples taken (12-13 tubes) during each visit while I was on active drug. The phlebotomist was great, and she moved quickly and just made it as pleasant as possible. I was also given my results at the follow-up visits, and I liked being well informed.

Q: What thoughts do you have around the patient-centric movement in clinical trials now?
A: First and foremost, the doctors and the study coordinators are key. How they treat the patient is key. The GI research team at Duke was like family to me. I was not “just a research patient” to them; I was a person first, and they certainly made me feel like they cared.

I was a bit surprised by the lack of branding on the study supplies I was given. There was nothing that informed me of who the sponsoring pharma company was. I was carrying around three bottles of pills in a regular zip-lock bag.  It would have been nice to have a branded pill box (I was taking eight pills in the morning and three pills in the evening), so something functional provided as part of the study supplies would have been good.  While I knew who the pharma company sponsor of the trial was, there was nothing that reinforced their brand as I participated in the study. I thought that was very unfortunate, and I saw this as an opportunity lost for them. I am grateful for the cure I received.

I wanted to feel like I was a part of something. I felt like I was helping to find a cure for a very hard to treat disease – and I just wanted to feel connected with the study – and to the people who created this study.

The study results were provided to me at the end of the trial. I was called and informed about my viral load as well as my ALT/AST’s.

At the end of the study, (six months post treatment) I came in for my last visit. There, I was officially informed that I remained “non-detectable” and was considered cured. The crowning jewel was the letter I received to provide to my insurance company informing them that I was cured of Hepatitis-C.