Vivek Subbiah: Clinical trial vs fiction

Vivek Subbiah shared an article on LinkedIn:

”Every single drug, medicine, and treatment you’ve ever received has gone through clinical trial testing.

Clinical trials are reliable scientific studies where patients volunteer to test new theories, medicines, or treatments. The trials help scientists and the greater medical community:

• Determine the safety of new drugs or treatment options.
• Evaluate the most effective dosage levels.
• Expand treatment availability to patient populations previously not represented in testing, such as modifying medications intended for adults for use in children.

While these trials are essential to advancing medicine, many misconceptions can often prevent patients from enrolling.

Myth: There aren’t many clinical trials, and they are only offered at hospitals or academic facilities.

Fact: There are hundreds of thousands of clinical trials offered in many settings, including community-based cancer centers.

There’s a common misconception that clinical trials are rare and hard to find. In reality, there are nearly 6,500 cancer-related clinical trials happening around the world right now. One study found that 80% of clinical trials are delayed due to recruitment challenges, partly because of participation criteria and partly because patients aren’t aware of their options.

As a patient, if you meet the criteria, you can enroll in a clinical trial, even without a referral from your doctor. You may have access to the latest trials right in your community. SCRI works with locally-trusted oncology practices across the country to bring clinical trials to people close to home. With more than 250 sites in 24 states, SCRI has more than 1,000 actively enrolling clinical trials.

You can be proactive by researching clinical-trial participation and discussing options with your healthcare provider.

Myth: Clinical trials are a last resort and can delay treatment or limit other treatment options.

Fact: Participating in a trial with a new therapy approach may be even more effective and safer than existing ones.

As science is continuing to progress and new treatments are being explored, we’re realizing how tailored clinical trials can be to a patient’s unique cancer. Two patients with similar diagnoses may have different genetic drivers of their cancer. Many targeted therapies are available in clinical trials.

Clinical trials do not limit access to other care. Being in a clinical trial gives patients the opportunity to receive therapy that may be more effective or better tolerated than therapies that are currently available. In cancer clinical trials, placebos, or inactive medications, are never used in place of the best-known standard of care. If they are used, they are given along with an active drug.

Myth: Clinical trials are not safe.

Fact: Extensive research is conducted on a new treatment and must meet certain criteria before being eligible for a human clinical trial.

Before a new treatment is tested with patients, several key groups oversee clinical trials to ensure patient safety, including: an Institutional Review Board (IRB), the Office for Human Research Protections (OHRP), a Data and Safety Monitoring Board (DSMB), and the Food and Drug Administration (FDA). Each plays a critical role in evaluating treatments for patient safety and can stop the trial if necessary due to patient concerns.

Additionally, a research team member will explain the study details and answer any questions patients may have before enrolling.

Below are a handful of questions that may be helpful to ask your provider:

• What is the purpose of the trial?
• What kinds of tests or procedures will be done during the trial?
• What are the possible risks of this treatment?
• What are the possible long-term risks and benefits?
• How will the trial affect my daily life? How often will I need to come to the clinic?
• Do I have to pay for any of the treatments? What costs will my health insurance cover?
• Who has reviewed and approved the study?
• If I benefit from this therapy, will I be allowed to continue receiving it after the trial ends?

Once the trial has started, you will be closely monitored so you can rest assured that your symptoms are being thoroughly observed by experts in the field. They look at every single lab, medicine, symptom, and concern you may have and carefully consider the impact on you and your health. All clinicians and researchers follow strict protocols, making sure all tests are done precisely as they should be.

Your research care team will help guide your treatment, answer your questions, and make sure you are involved in your care.

Myth: Clinical trial participation is only for patients with advanced cancers.

Fact: Clinical trials are available for a wide range of cancer stages and types, not just advanced cancers.

Every clinical trial outcome has allowed medicine to evolve to where it is today. Today, clinical trials are available for first-line treatment, common cancers, and other subjects of interest. Participating in a clinical trial offers patients access to additional options that may be safer or more effective than current treatments, along with close monitoring by their care team.

Beyond personal benefits, clinical trial participation across all types of trials advances cancer research, potentially improving treatment options for current and future patients.

Today, SCRI’s research network brings together 1,300+ physicians who are actively enrolling patients into clinical trials. The contributions of patients enrolled in SCRI’s clinical trials has contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.

If you’re facing a cancer diagnosis and are seeking treatment options, consider talking to your doctor about clinical trials. These trials not only shape our understanding of cancer treatments, but also offer patients one thing we can’t prescribe: HOPE.”

Source: Vivek Subbiah/LinkedIn

Vivek Subbiah is the Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute (USA). He is the former Executive Director of Oncology Research and former Associate Professor in the Department of Investigational Cancer Therapeutics at the MD Anderson Cancer He focuses on translational cancer research and the design and implementation of early-phase biomarker-driven clinical trials. His work specifically targets antibody-drug conjugates, radiopharmaceuticals, immunoconjugates, and basket trials.