Clincial Trial Bottleneck

I always thought that clinical trials were something you considered doing as a patient when there were no other treatment options available. It made sense to me that you would try all the conventional treatment options first and then, if all else failed, resort to trial drugs. It’s a fair assumption, but it’s wrong. In many cases, using a trial drug first may be the better option.

A newly diagnosed cancer patient does not typically think to ask their physician what trials are available to them before beginning “standard of care” treatments. Most physicians are themselves are not familiar with all of the trials available and the eligibility criteria for participation. A quick search for lung cancer trials currently recruiting patients at the National Institute of Health’s website (www.clincialtrial.gov) reveals that there are over 1000 open trials related to lung cancer alone. There is no way to easily find a trial other than to do a search and narrow down or refine the criteria to meets your needs, condition and location. In many cases it will be up to the patient to find a clinical trial and then consult with their physician about the benefits of participating.

Clinical trials are an important part of cancer research and medical research in general. Unfortunately, the patients “accrual rates” for many studies are so low that trials are frequently closed for lack of participation. It’s estimated that only 3% of newly diagnosed cancer patients enroll in clinical trials – an exceedingly low number. I saw one study that declared that more than 40% of all oncology trials “don’t meet the minimum target for patient accruals.”

Clinical trials are the bottleneck to faster advancement in cancer research. We all have a stake in seeing cancer research advance more rapidly. A recent report from the National Cancer Institute estimates that 41 percent of Americans living today will develop cancer in their lifetime; one in four will eventually die from the disease.

One study that looked into the reasons for low accrual rates for cancer patients in clinical trials reveals that of the 276 patients studied only 14 percent ultimately participated in a trial. The most common reasons for patients not participating were elimination by their physician due to perceived availability or poor performance status; the desire for other treatment and distance from the available trial sites.

The Phase III Stimuvax trial I am enrolled in requires 1200 patients be recruited. There are 259 sites around the world participating in this particular trial with four here in Florida. It may take five years or more before 1200 patients are accrued and the study completed.

Before joining a trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied, while others need healthy participants. Clinical trials require that patient sign a document that explains the risks and benefits of the trial, called an “Informed Consent.”

All clinical trials have guidelines about who can participate. The factors that allow someone to participate are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

In my case the inclusion criteria for enrolling in the Stimuvax trial was having been diagnosed with nonresectable Stage IIIA adenocarcinoma. Exclusion criteria included having any sign of metastatic disease. I also had to meet a strict time window from the end of conventional treatment to enrollment.

The internet makes it fairly easy to research available clinical trials. One day electronic medical records may automate matching patients with trials and improve recruitment. In the meantime, patients need to be their own advocate. Being proactive may get you access to state of the art medicine and the chance for a better future.