Clinical Trials Move into the Mainstream

Frank Ingari, CEO of Cure Forward

The newly diagnosed cancer patient often experiences a new relationship with time.  How much time do I have?  How quickly can my treatment begin?  How will I use my time differently now?

Making sure a patient gets the right treatment as early as possible can be the difference between life and death.

Doctors recognize this reality and move swiftly to get patients onto the “Standard of Care,” typically including some combination of surgery, radiotherapy, and chemotherapy.  While there have been tremendous advances, for many forms of cancer it remains true that “success” with the Standard of Care is measured by how many months can be added to the patient’s life, and not by the ability to cure the disease in the way that strep throat can be cured by an antibiotic.  In many cases, doctor and patient expect even a “successful” course of chemotherapy to fail at some point, leading to more rounds of treatment.  In other words, the Standard of Care often includes an implicit journey from one round of treatment to another.

Cancer touches everyone  — so everyone knows that these multiple rounds of chemotherapy can degrade the immune system and reduce the effectiveness of subsequent treatments.  Cancer threatens everyone – so doctors, patients, regulators, and politicians all share as human beings a great hope that the biopharma industry will continue to create new and radically superior treatments for more and more forms of cancer.

Cancer research is in fact moving with unprecedented scale and speed.  New insights into the drivers of cancer formation, the role of genetic mutations, how resistance to treatments develops, how the immune system can be harnessed to defeat cancer  —  progress on these fronts is inspiring.  Now, after decades of research fueled by the sequencing of the genome and by the application of massively powerful computing to drug development, research is producing a strong flow of new therapies that researchers believe are ready for introduction into the Standard of Care.

As always, these therapies can only reach patients after undergoing the Clinical Trial process, an essential tool for validating the safety, efficacy, proper dosing, and side effect management strategies recommended by the drug developer.

Historically, during periods when new therapies offer only marginal, incremental improvements, we rely on patients who demonstrate a mixture of hope for a better personal outcome with a willingness to take a risk in order to help others.

This is not that time.  Today, for a growing number of cancers, drugs available only in a clinical trial can offer an arguably superior alternative to the Standard of Care.

Of course, as good as the early data may look, the clinical trial therapy is arguably superior until it is proven superior.  The new drugs must undergo the rigorous clinical trial process to discover whether long term success and less onerous “side effects” are borne out over time, across the population.

But the inherent logic of the new approaches  —  such as harnessing the power of the patient’s own immune system, or targeting treatments to the patient’s specific genetics  —  offers powerful appeal when compared to the “cytotoxic” approach of conventional chemotherapy.

Today, at an accelerating rate, patients and doctors are realizing that access to clinical trial options must be considered from the very start of the treatment regimen.

This is true not only because the new drugs may offer arguably superior results compared to the Standard of Care.  It’s also true because the sequence of therapies has profound implications for the patient’s prognosis.  Certain chemotherapies, for example, may prevent the use of immunotherapies later.  Given the rapid development of new immunotherapies, and the pace of FDA approval of such drugs for more cancer types, planning the sequence of therapies up front is a serious concern for patients and their physicians.

It is extremely challenging for patients and their physicians to address this concern.  While interest in clinical trials from the start of treatment is growing fast, the current healthcare system does not offer tools, resources, or rewards for exploring the clinical trial option.  For example, doctors receive zero reimbursement for the many hours it can take to explore the thousands of clinical trials actively recruiting patients across the US at a given moment.  For doctors struggling with “time famine,” splitting ten or twenty minutes between patient examination and data entry into the EMR, exploring trials is often a complete non-starter.  Sticking to the Standard of Care is their only option.

Patients are drawn increasingly to the new therapies, but are often afraid that they will be on the “placebo” side of the clinical trial.  The FDA has approved new approaches to reduce this concern; for example, in most new oncology trials, there is no “placebo” as such.  Patients who do not receive the new drug will receive the Standard of Care  —  exactly the care they would receive if they did not enroll in a clinical trial at all.  What’s more, in many trials there is now a “crossover” option  —  meaning that if the patient begins to fail under the Standard of Care, they can be moved over quickly to the drug being tested.  In addition, the data suggests that even those patients who receive Standard of Care in clinical trials do better than patients who get the same treatment outside of the trial setting  —  probably because clinical trial treatment protocols are tightly defined and monitored to ensure strict compliance with the optimal application of the standard.

I work at Cure Forward, a company whose mission is to transform how patients access the growing wave of cancer therapies available only in clinical trials.  We are shocked continually by how many patients fail to find places in highly desirable clinical trials because they lack personal connections to find the right doctor at the right academic medical center supervising the trial that is right for them.

Yet many of these very same trials are delayed substantially by the inability to find patients, delaying not only the delivery of FDA-approved medicines, but slowing the overall pace of learning and innovation.

The well-documented fragmentation and mystifying complexity of our healthcare “system” seems to guarantee that no one is satisfied nor served by how clinical trials are filled today.

This week we celebrate Clinical Trial Awareness Week, which seeks to inform patients, doctors and caregivers about the benefits of clinical trials and how they can open doors to life saving treatments.  This is the essence of our work at Cure Forward.  We provide a personal guide, knowledge, and tools to each patient who seeks our help.

Our work would be impossible without the support of people across the industry  —  treating oncologists, trial investigators, biopharma drug developers, payers, hospitals, and labs.  We are inspired and gratified to experience growing support for moving clinical trials into the mainstream of cancer care.  Every day, we benefit from growing awareness, goodwill, and cooperation from all corners of the oncology world as we help patients through their profoundly specific and personal journey.