Observational Clinical Trial Interventional Clinical Trial

In observational or non-interventional trials, a patient’s clinical data or tumor samples support laboratory research for biological discovery; these trials do not change the patient’s treatment course.

Patient Involvement

Donation of blood samples, tumor biopsy samples, imaging data, or laboratory studies

Interventional trials tend to be more widely known by cancer patients, as they have been popularized for testing the safety, dosing, and efficacy of new therapies.

Enrollment in a study where a new drug or treatment is being tested

Examples of Study Goals

Study the biology of cancer cells within patients’ biopsy specimens

Use patient data to predict future cancer reoccurrence or disease progression

Develop new methods of detecting or tracking cancer progression

Determine the safety and effectiveness of a new drug or drug combination

Determine optimal drug doses

Study and minimize drug side effects

Study new, advanced surgical methods

Study alternative radiation methods and dosing

Examples of Previous Research Findings

Discovery of BRCA genes in breast cancer

Use of CEA and CA 19-9 labs for predicting colon cancer progression

Development of PET scans for cancer monitoring

Use of immunotherapy drugs for metastatic cancers

Replacing chemotherapy with new targeted therapies with fewer side effects

Advancing immune cell replacement therapy

Why participate in research?

Through clinical trials, patients can contribute to the scientific knowledge needed for understanding and treating their disease, now or in the future. Additionally, as a participant in interventional trials, a patient can gain access to new drugs or treatment regimens not yet available to the public. This can be especially helpful for patients who have failed all currently available therapies. Interventional trials are a way to try something that may be effective and, on a larger scale, could help thousands of other patients like them for years to come.

Who is eligible to enroll in clinical trials?

All clinical trials have strict “inclusion” and “exclusion” criteria which are established before a trial begins. These criteria vary widely depending on the goal and nature of the study. The first step as a patient is to gather details about one’s cancer (such as cancer type, stage, genetic mutations, and treatment history) and speak with one’s physician to determine eligibility.

What if I’m not eligible for a clinical trial but have exhausted all current treatment options?

In special circumstances, some patients may gain access to new drugs outside of clinical trials through “compassionate use.” Some drug companies are able to offer new and promising drugs (that have yet to be FDA-approved) at no cost to patients. A patient with limited options should speak with her doctor about any alternatives that may be available through “compassionate use”.

I’m interested in enrolling in a clinical trial. Where do I find one?

Many clinical trials take place in large, academic hospital systems with National Cancer Institute (NCI)-Designated Cancer Centers, which are often in major cities. However, many clinical trials have satellite sites in community practices or medical centers across the country, thus offering additional opportunities for patient participation.

Before embarking on any clinical trial, patients need to discuss all options as well as the risks/benefits with their physician. A patient’s doctor might be able to help them find a clinical trial that is right for them while evaluating all available treatment options. The best way to start looking for a clinical trial is in conjunction with one’s doctor.

How do I know if a trial is legitimate?

Patients should never be asked to join a trial without the assistance and support of their doctor(s). Steer clear of any scams, including any instance where a center asks the patient to pay to participate in a trial. Legitimate clinical trials never require patients to pay to receive a new treatment. In some studies, patients may actually be compensated for their time and involvement.

What if I change my mind after I enroll?

Enrollment in any clinical study is not a permanent or strict contract. If a patient decides to cease involvement at any time, for any reason, she can withdraw by informing the research team and doctor.

What are the risks and benefits of clinical trials?

As with any new or exploratory treatment, an interventional clinical trial comes with the risk that the drug might not work as predicted or that the drug causes unforeseen side effects. However, very strict rules are in place to minimize risk to patients. The ultimate goal of any study is always to give patients the best alternative to any traditional treatment or a better one. Any ongoing trial will be immediately halted if the drug or treatment under investigation is proving to be ineffective or dangerous. Trials are flexible and patient safety will always be prioritized.

The benefits of participating in a trial include access to new drugs and treatment strategies that are unavailable to the general population of cancer patients, increasing options for those who have exhausted all others, and contributing to cuttingedge research. Many patients find satisfaction in knowing that they are helping provide scientific knowledge for future patients and generations to come.

Conclusion

Our understanding of cancer and the rapid development of new treatments today would not be possible without patients who contributed to research. While not all clinical trials can be “success stories”, each one strives to advance the field and improve the lives of future patients. The Nobel Prize-winning cancer treatment called immunotherapy was first implemented in a clinical trial starting in 2004 in a set of metastatic melanoma cancer patients, many of whom thought they had less than a few years to live. Decades later, many of these original clinical trial patients are still alive because they received a new drug that is now routinely used today. Through clinical trials, scientists, physicians, and patients will continue working closely together with the shared goal of conquering cancer.