The Business of Clinical Trials: An Interview with Bartosz Chmielowski, MD, PhD

Dr. Bartosz Chmielowski, MD, PhD, is an Associate Professor of Medicine at UCLA. Currently involved in over 20 clinical trials, Dr. Chmielowski specializes in sarcoma, melanoma, and other types of skin cancers.

Q: Only 8% of cancer patients currently participate in clinical trials. Why do you think that number is so low?

In the US, you are paid for what you do, and not paid for what you don’t do. Physicians make money from seeing and treating their patients, but if a physician refers their patient to a clinical trial, or an academic center, they lose the income. This often leads physicians to recommend approved therapies that they can administer themselves.

There are also patients who are disinterested in joining a trial because trials are viewed as a medical experiment or a last resort. However, all trials are reviewed by scientific and ethical committees and approved for their target population. Notably, clinical trials are more time consuming due to more office visits and lab work, which means trial patients are under much closer supervision than patients on standard therapy.

Q: For those patients who don't know how to find a trial, what is the best resource for them to use?

The best resource is clinicaltrials.gov. Everyone who opens a trial in America must register with the website and include some basic information. However, it is still difficult for patients because they can use the site to search for trials under the name of their cancer, but then receive hundreds of results and not know which to choose.

Oncologists are not a perfect resource either because it's impossible for one to encompass knowledge of all open clinical trials while also running their practice. My recommendation is that it’s always better to go to an oncologist that specializes in the patient's disease.

Q: Is there a difference between trials run by drug companies vs. academic medical centers?

A main difference stems from multiple drug companies targeting the same common cancers, due to the high demand from patients. These companies use drugs of similar mechanisms and they all need patients to run their trials to get their drug approved first. This competition can slow the process down.

Q: What should a patient know when entering a Phase I trial?

The earlier the trial the more complicated it is. Doctors will enroll patients in cohorts because if you have a new drug you don't know the toxicity, and you don't want to expose so many people to the new drug all at once. Instead, you enroll a small number of patients at first, three or so, and if the patients don’t experience any side effects then you enroll the next three, and so on.

This may cause a delay in starting the new treatment, as a trial may be open, but if a patient comes just after the first three patients were enrolled, then the next slot may not be open for another month. We don't want to leave patients in limbo, and that's why keeping all their doctors and specialists informed is key.

Q: Are there any positive takeaways you noticed from your own practice?

My practice is busier and busier and it’s not necessarily that we have more patients being diagnosed with cancer, but because our patients are living longer - and this is what we always want! Five or seven years ago if a patient was diagnosed with metastatic melanoma, only 25% of them survived one year. Now it's 75% of patients who survive one year, so of course the patients come back to the clinic, making the clinic busier because of our success!