In a WebMD Reddit AMA about clinical trials, cancer researcher Marina Baretti, MD, discussed a variety of topics, including AI integration, typical clinical trial processes, and emerging research.
Baretti, an assistant professor at Johns Hopkins University School of Medicine in Baltimore, focuses on finding new treatments for liver, bile duct, and gallbladder cancer. She is the Jiasheng Chair in Hepato-Biliary Cancer Research and also serves as co-director of the Liver and Biliary Cancer Multidisciplinary Clinic at the Sidney Kimmel Comprehensive Cancer Center (SKCCC).
Here are some questions and answers from the Reddit AMA event.
How are you using AI to explore new avenues in research?
Baretti: AI is an important new tool, and we’re still learning how to use it at its best. There are important efforts underway to integrate AI to facilitate drug discovery and to better match therapies with the right patients. It’s also being used to analyze large datasets (genomics, imaging, clinical data) in ways that would be very difficult for humans alone, which can help identify patterns and generate new hypotheses. That said, we’re still early, and these tools need careful validation before they truly change clinical care.
How many years go by during trials before a new medicine is released to the public?
Baretti: It varies quite a bit. It depends on what treatments are already available for that disease, how well they work, and how strong the data is for the new drug. Some drugs — especially if they show very promising results in diseases with limited options — can receive accelerated approval and become available within a couple of years. Others require more time to go through all the necessary phases of testing to fully establish safety and effectiveness, which can take several years.
What would you say are some of the most common misconceptions people have about clinical trials?
Baretti: One is the fear of being placed on a placebo and not receiving an active treatment. But in oncology, placebos are almost never given instead of treatment when an effective standard option exists. They’re usually added on top of standard care. Another common concern is the idea of being “used for testing.” In reality, clinical trials are very closely regulated with strict safety monitoring, and patients can withdraw at any time.
People also often think trials are a “last resort,” but that’s not always the case. Many trials are available earlier in the disease course and can be a very reasonable option.
There’s also a perception that trials are inherently riskier than standard treatments. While there is uncertainty, standard therapies also have risks, and in trials patients are often monitored even more closely.
If the clinical trial data is good and research is progressing to the final phases, how can people get access to this potentially lifesaving medicine sooner rather than later? What about a study that is in the earlier stages?
Baretti: Even when a study looks promising, most trials are still steps along the way, and it takes time to know how effective a treatment truly is. That said, if a drug is showing strong results, there are sometimes ways to access it earlier, through clinical trials, expanded access/compassionate use programs, or — occasionally — early, accelerated FDA approvals. For earlier-stage studies (often known as phase 1 or 2), access is usually only through the trial itself, and eligibility can be more limited.
In situations where the disease is progressing and options are limited, we do sometimes think more creatively. This can include early-phase trials, off-label treatments, or compassionate use. These are very individualized decisions, balancing potential benefits with risks.
Do you see a future where cancer treatment is more tailored to individuals or a combination of treatments for each case?
Baretti: I think we’re moving more and more toward personalized medicine, where we really try to match treatment with the underlying biology and molecular makeup of each tumor.
Why is the system for finding clinical trials so confusing?
Baretti: Navigating clinical trials can be very difficult for patients and caregivers. There are advocacy groups and foundations that do a great job keeping patients informed about trials, hosting webinars, and sharing updates — so I always encourage my patients to stay connected with those groups. There are also ongoing efforts to create disease-specific consortia to help facilitate trial enrollment, but this process is still far from optimal.
Why do initial meetings with clinical trials require in-person meetings?
Baretti: A key part of trial eligibility is assessing what we call “performance status,” along with a full clinical evaluation, including a physical exam. Since we’re often testing new drugs and trying to understand their safety, we need to ensure there are no obvious contraindications that would make participation unsafe. For a physician seeing a patient for the first time, it can be difficult to fully appreciate some of these nuances, especially over video, which can also add to the complexity of trial enrollment.
Many drugs are first tested in healthy volunteers to establish initial safety. Do oncology drugs follow the same model?
Baretti: When we think about phase 1 trials in oncology, these are almost always conducted in patients who have cancer — not in healthy volunteers. There are very strict rules around dosing and scheduling to ensure safety. Typically, trials start at a lower dose and gradually escalate only after a period of observation, with very close monitoring (e.g., frequent blood work, visits, etc.). The goal is to find a safe and appropriate dose while minimizing the risk of significant toxicity.
Will there ever come a time when a patient can choose to participate in a clinical trial before or instead of FDA-approved treatments?
Baretti: This is already an option for patients in many cases. That said, it requires a thoughtful discussion with your physician and oncology team, weighing the known benefits of approved therapies against the potential risks and uncertainties of a trial. The right choice really depends on the specific situation, the type of cancer, and the available data.
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SOURCES:
Marina Baretti, MD, assistant professor, Johns Hopkins University School of Medicine, Baltimore.
National Cancer Institute: “Clinical Trial Facts.”
