Patient Perspective in Clinical Trials

Advocacy Groups | <b>Fight Colorectal Cancer</b>

Since Fight CRC’s inception, we’ve recognized the need to put the patient voice in all things research, ensuring that science has the community’s best interests in mind.

The patient perspective is at the heart of what we do. Since Fight CRC’s inception, we’ve recognized the need to put the patient voice in all things research, ensuring that science has the community’s best interests in mind.

The RATS program does just that. It trains advocates on the research so they can work alongside scientists and make sure that their perspectives are being heard and taken seriously.

Julie Krause, a stage IV colorectal cancer (CRC) survivor joined the RATS program in 2015, and ever since has been a fierce advocate for clinical trials. Not only does she curate clinical trials into the back end of the Fight CRC trial finder, but she sits on panels reviewing clinical trials as well.

One of the panel’s Julie serves on is the Alliance for Clinical Trials in Oncology. The Alliance “develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and cancer prevention strategies, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program. The Alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada.”

We interviewed Julie to learn more about her experience serving on the Alliance clinical trials panel.

1) How did you get involved in the Alliance?

I became involved in the Alliance in the fall of 2018. There was an opening for a patient/research advocate to serve on the gastrointestinal scientific steering committee. They reached out to Fight CRC, who let me know about the opportunity, so I sent the Alliance my application, biography, and CV and was accepted as a patient advocate.

2) Why is it important that the patient voice is included in these types of groups?

Researchers and doctors are developing clinical trials from a different perspective than the patients. As a research advocate, my job is to protect the patient’s perspective.

Over the past three years, I’ve seen tremendous improvement in the design, inclusion criteria, and patient quality of life (QOL) surveys in clinical trials. We are evaluating trials to protect the patient from perhaps unnecessary invasive testing, making sure trial design and any patient costs are transparent in the consent forms, making consent forms easier to understand, at times strongly suggesting design changes that will give more patients access to the trial drugs and — in general — make sure the patient perspective is considered and protected.

3) What does this panel entail and what types of clinical trials do you review?

I am involved in concept development. Sometimes getting a trial from concept to bedside may take years. I have been working on one for rectal cancer for two years now. It is finally going through its last iteration as a Phase 3 trial and will be practice changing if the hypothesis bears out. The implications could improve organ preservation in this population significantly and give physicians standardized guidelines in the most effective treatment to achieve this goal in patients that meet the inclusion criteria.

I am also involved in immunotherapy trial concept design, although this is still getting off the ground with the Alliance. I also review concepts with the Symptom Intervention committee. I am on the Patient Advocate committee and the Plain Language Summary committee. The Plain Language committee involves rewriting completed trial results in language that a lay person can understand. These are then published on the patient-facing portion of the Alliance website. Recently, new Division of Cancer Prevention (DCP) concept submission template guidelines were implemented, so now there is a requirement to include a patient advocate summary for new concepts. I have been asked to assist with writing those as well.

4) What type of research do you hope to see the Alliance conduct going forward?

The field of cancer research is evolving so rapidly since there has been improved understanding of the tumor microenvironment and the cascading effect of different mechanisms involved in oncogenesis. Additionally, a better understanding of resistance, relationships, and outcomes with the microbiome, vaccine delivery systems, and many other new technologies involving diagnosis and monitoring existing disease. I would like to see them pursue strategies that will lead to cures and improved quality of life for all cancer patients and cancer types.