Kain to Help Lead Clinical Trials Board

Joshua Kain, MD, FACS, Assistant Professor of Otolaryngology – Head and Neck Surgery, has been named Vice Chair of the Data Safety and Monitoring Board for Clinical Trials for Houston Methodist’s Dr. Mary and Ron Neal Cancer Center. The clinical trials board is an important step in the Neal Cancer Center’s drive to receive National Cancer Institute designation, and Kain’s appointment highlights the department’s enhanced role in head and neck cancer, which is Kain’s specialty. The committee’s job is to overlook cancer clinical trials, serving as a check point between researchers and patients.

Joshua Kain, MD, FACS

“Our first and foremost goal is to assess whether the practices and the experimental arms of these trials are ultimately safe for patients. It’s simple, and it is very logical,” said Kain, who added that the board’s decisions are based more on common sense than on medical knowledge. “The bottom line is ‘Is this good for people?’” he said.

Kain and other members of the multidisciplinary committee are assigned cumbersome records and data for a current clinical trial that is not in their specialty of practice. After reviewing the trial protocol and patient data, the member will then present the information to other committee members at quarterly meetings. Because assignments are not given in a physician’s specific area of expertise, Kain often reviews breast cancer and chemo-therapeutic trials.

“You’ll always see more involvement from medical oncologist and radiation oncologists on these types of boards because they are typically the ones who are primary investigators for these trials. It’s very difficult to have clinical trials in surgery, owing to a handful of historic case studies in which people have abused the privileges and performed surgeries not appropriate for patients.” Kain added, “The committee is like a well-run board for a large company. Committee members are not so fixated on the inside workings or the detail. It’s more well-rounded. I might not understand the pathways and mechanisms of certain immunotherapies that are being used in an experimental fashion, but I can very much understand whether it’s benefitting or not benefitting the patients.”

My overarching goal in my role on the committee is for Houston Methodist’s cancer center to reach that NCI designation. It’s an important institutional goal and well within reach. It’s attainable and overdue. We certainly need to push all measures to help us reach that goal.

Joshua Kain, MD, FACS

Assistant Professor of Otolaryngology – Head and Neck Surgery

The medical system in the United States “almost demands” that physicians and researchers are constantly pushed as an academic center to be on the forefront of innovation and producing deliverables in terms of research.

“That can come at a cost because some things are pushed out hastily and in an effort to be first, foremost or cutting edge. Ultimately that can be in direct contradiction to what’s safe and beneficial. The ethical dilemma is to determine if these trials are ultimately benefiting the people or are they causing harm.” Cancer patients are not typically thought of as a vulnerable population but, in many ways, they can be more vulnerable than pregnant women, children, ethnicities, socio-economic groups or prisoners who are clearly seen as vulnerable. “Cancer patients can be in a state of desperation and have few options available to them. They make weighty decisions that often don’t have a lot of strong evidence and experience behind them in the hopes of maintaining life itself,” Kain said. “It is important to see for the patient where harm is occurring. You must bring a very objective vantage to the decision.” The committee reviews any investigator-initiated clinical trial through the cancer center. They look at protocol, pre-clinical data, clinical data, design, and reports on any adverse events. “My overarching goal in my role on the committee is for Houston Methodist’s cancer center to reach that NCI designation. It’s an important institutional goal and well within reach. It’s attainable and overdue. We certainly need to push all measures to help us reach that goal,” he said. He added, “The beauty of having an inside voice on the committee is the hope of seeing more head and neck cancer trials reach fruition and reach our patients. Where I don’t have conflicts or bias, I’m heavily supportive.” He said he is particularly interested in seeing more neoadjuvant trials with immunotherapy for head and neck cancers where patients receive treatment before going through either surgery or radiation. This pathway would serve as introductory treatment to reduce the volume of a tumor so that it becomes operable or even curable.