Dr. Meirovitz:

This is never an intuitive decision. There are very specific eligibility criteria. We evaluate:

• the exact type of tumor
• the stage of disease
• previous treatments
• the patient’s overall condition
• and, in some cases, specific molecular characteristics of the tumor

For example, if a patient’s tumor carries a particular mutation and there is a study targeting that mutation, it may be an excellent match.

But if the patient does not meet the eligibility criteria, I would never recommend a trial simply “to see what happens.”

The biological and clinical fit must be appropriate.

That is critical.

Dr. Roman Meirovitz:

This is probably the most important question because it addresses one of the biggest fears patients have.

When people hear the phrase “clinical trial,” they often imagine something unpredictable, experimental, or risky.

But a clinical trial does not begin from scratch. Before a treatment ever reaches patients, it has already undergone preclinical testing, laboratory research, and often early safety studies.

We do not administer treatments for which there is absolutely no information.

In addition, every clinical trial follows a very strict protocol. There are clearly defined eligibility criteria.

There are scheduled evaluations.

There are mechanisms designed to stop a study if unexpected safety concerns emerge.

In many cases, monitoring within a clinical trial is actually more intensive than with standard treatment.

Patients often undergo more frequent assessments, laboratory testing, and imaging studies.

Any side effect is carefully documented and reviewed.

However — and this is important to say honestly — there is always a degree of uncertainty. We cannot always predict exactly how a treatment will affect a specific individual patient.

But standard treatments are not completely risk-free either.

The difference is that in clinical research, there is full transparency regarding what we know, what we do not know, and what we are still trying to learn.

And that transparency is an essential part of helping patients make informed decisions.

Dr. Meirovitz:

This is a very important and very sensitive topic.

Many people automatically assume that a clinical trial means more aggressive treatment, more severe side effects, or a greater burden on the patient.

But that is not necessarily true.

Some clinical trials are specifically designed to reduce treatment burden. For example:

• lowering the treatment dose
• shortening the duration of therapy
• or finding combinations that provide disease control with less toxicity

There are also studies focused on very specific groups of patients, allowing treatment to be delivered in a more precise way.

And sometimes that precision can actually improve quality of life.

On the other hand, some studies require more frequent hospital visits, additional testing, and closer monitoring.

And that is something we must consider carefully.

When I discuss a clinical trial with a patient, I am not only asking: “Could this treatment work?”

I am also asking: 

• How will this affect this person’s life?
• Are they still working?
• Do they have family support?
• Will they be able to attend frequent follow-up visits?
• How much energy do they currently have?

Quality of life is not a secondary issue. It is part of the treatment decision itself.

Some patients choose a clinical trial because they want access to the latest treatment advances. Others see it as an additional opportunity.

And some prefer standard therapy — which is completely reasonable.

The goal is not to persuade. The goal is to help people make informed decisions.

Dr. Roman Meirovitz:

An approved drug is a treatment that has already completed all stages of clinical research.

Its safety has been evaluated.

Its effectiveness has been evaluated.

And it has been compared with existing standards of care before receiving regulatory approval for broad use. That means we have substantial data regarding:

• how effective it is
• which patients are most likely to benefit
• what side effects are expected
• and how those side effects are typically managed

An investigational treatment is still undergoing evaluation. In early phases, we focus mainly on safety and dosage. In later phases, we compare the treatment against current standards.

But it is important to understand something. An investigational drug is not a random experiment.

Usually, it is based on a very specific biological mechanism and supported by encouraging early data.

The main difference is the level of certainty.

With an approved treatment, certainty is higher. With an investigational treatment, there is potential — but also more uncertainty.

And sometimes that uncertainty is exactly where meaningful progress begins.

Dr. Meirovitz:

Yes.

And in colorectal oncology, that is actually quite common.

Many clinical trials are designed for patients who have already received one or more lines of therapy and whose disease has continued to progress.

However, timing is extremely important. If we wait too long and the patient’s overall condition declines, participation in a trial may no longer be possible.

That is why we do not only think about: “What treatment should we choose today?”

We also think about: “What options may be important in the future?”

There are studies designed for earlier stages of disease as well. For example, trials that use molecular profiling at the beginning of treatment to guide therapeutic decisions.

So an important point is this: Patients do not always need to wait until the disease becomes more advanced before discussing clinical trial options.

Dr. Meirovitz:

In most cases, the investigational treatment itself and the study-related tests are funded by the organization conducting the trial — whether that is a pharmaceutical company or an academic institution.

Patients generally do not pay for the study medication.

However, there may be indirect expenses:

• Travel costs.
• Time away from work.
• And sometimes tests that fall outside the study protocol.

It is also important to understand that every clinical trial has very specific eligibility criteria.

There are defined procedures, monitoring requirements, and treatment protocols. In many cases, if treatment proceeds without complications, the study covers all protocol-related care.

However, unexpected situations can occur. For example, emergency room visits, hospitalization, or medical issues that are not directly covered by the study protocol.

For international patients in particular, it is important to understand these details in advance and review financial coverage before enrollment.

I always emphasize that participation in a clinical trial should be a medical decision, not a financial one.

Dr. Meirovitz:

That is actually a very personal question.

Because recommending a clinical trial is not the same as prescribing a standard treatment. There is a double responsibility involved.

On one hand, you want to offer a patient access to an advanced treatment that may potentially provide additional benefit. On the other hand, you must be honest about what we know and what we still do not know.

I try to present a clinical trial as an option — not as the only correct path.

Some patients immediately feel that it is the right choice for them. Others need time to think about it.

And some prefer a well-established standard treatment. I respect all of those decisions. Because medicine is not only science. It is also a relationship between physician and patient.

Dr. Meirovitz:

Absolutely.

If you look at the progress made in oncology over the past two decades, almost every major advancement has been driven by clinical research.

Biologic therapies.

Immunotherapy.

Personalized oncology.

At one point, all of these approaches existed only within clinical trials.

And today, research continues to shape the future of cancer treatment. We are studying:

• treatment selection based on biomarkers
• smarter drug combinations
• earlier detection of recurrence using ctDNA
• ways to reduce treatment toxicity without compromising effectiveness

So a clinical trial is not only an opportunity for the patient participating today. It also helps define the treatments that may become standard tomorrow.

Dr. Meirovitz:

I would say something very simple: Don’t be afraid of the word itself.

Ask questions.

Seek clarification.

Request detailed explanations.

Participation in a clinical trial is never an obligation. It is one possible option among several.

And any good option deserves to be evaluated carefully and calmly – not through fear or pressure. 

At the end of the day, the goal remains the same: to choose the treatment that is most appropriate for the individual patient.

Dr. Roman Meirovitz:

Yes, this is actually an excellent example of how biology and clinical research come together.

Let’s start with MSI — microsatellite instability.

A number of years ago, most patients with metastatic colorectal cancer received chemotherapy as first-line treatment, regardless of the molecular characteristics of their tumor.

Then studies began showing that tumors with high MSI responded exceptionally well to immunotherapy.

Initially, these treatments were available only through clinical trials. The results were remarkable.

Response rates were significantly higher, and some patients experienced long-term disease control.

Today, because of those studies, immunotherapy has become a standard first-line treatment for patients with MSI-High colorectal cancer.

This is a clear example of research changing clinical practice.

Arthur Andonis:

And what about BRAF?

Dr. Roman Meirovitz:

The BRAF mutation, particularly BRAF V600E, was historically associated with a less favorable prognosis.

Conventional chemotherapy often produced limited results in this group of patients.

Researchers then began studying combinations of targeted therapies directed against BRAF together with EGFR inhibition.

At first, this approach was available only within clinical trials.

But the data demonstrated meaningful improvements in both response rates and overall outcomes compared with standard treatment.

Today, specific targeted treatment strategies exist for some patients with BRAF-mutated colorectal cancer.

And that is a direct result of clinical research.

Arthur Andonis:

What is happening now in the field of immunotherapy combinations?

Dr. Roman Meirovitz:

This is one of the most active areas of research today. The challenge is that most colorectal cancer patients are not MSI-High.

As a result, many ongoing studies are trying to understand how we can activate the immune system even in tumors that do not naturally respond well to immunotherapy.

Researchers are exploring multiple strategies.

• Immunotherapy combined with chemotherapy
• Immunotherapy combined with biologic therapies
• Novel immune-based treatment mechanisms

Not every study leads to a breakthrough.

But every study helps us better understand the disease and identify new treatment opportunities.

Dr. Meirovitz:

Exactly.

The transition from a “one-size-fits-all” approach to personalized oncology did not happen overnight.

It happened because researchers started asking different questions.

• What mutation is driving this tumor?
• Which biological pathway is active?
• Who is truly likely to benefit from immunotherapy?

Today, before starting treatment for metastatic colorectal cancer, we routinely evaluate:

• KRAS
• NRAS
• BRAF
• MSI

It feels completely natural now.

But these tests became standard only because years of research demonstrated their value.

Dr. Roman Meirovitz:

In my view, clinical trials are no longer on the margins of oncology. They are not simply a “Plan B.”

And they are certainly not reserved only for the final stages of treatment.

In many situations, clinical trials are part of the treatment landscape we evaluate when building a therapeutic strategy.

Of course, not every patient is a suitable candidate.

And not every study is appropriate for every clinical situation.

But many of the advances we consider standard today exist because of clinical research.

Particularly when we talk about molecular characteristics such as MSI-High tumors or BRAF mutations. There is another point I always emphasize.

The decision to participate in a clinical trial is never purely technical. It involves:

• medical factors
• disease characteristics
• quality of life considerations
• and the patient’s personal preferences

Some patients feel more comfortable with a well-established standard treatment. Others want access to the latest innovations. Both choices are valid.

My role as a physician is not to persuade. My role is to present the full picture, explain what we know, what we are still learning, and help patients make thoughtful decisions.

Ultimately, a clinical trial is not a goal in itself. It is a tool.

And the only question that truly matters is: Is this the right tool for the person sitting in front of me?