Few Cancer Patients Join Clinical Trials

With cancer rates soaring - an estimated 1.5 million Americans were diagnosed with cancer in 2010, according to the National Cancer Institute - there's an increasing need for better cancer treatments. But fewer than 1% of cancer patients join clinical trials.

In an article just published in the Annals of Surgery, Waddah B. Al-Refaie, MD and colleagues found that just 0.64% of patients with solid tumors enrolled in clinical trials. They analyzed data on 244,528 cancer patients from the California Cancer Registry from 2001-2008 ("Cancer Trials Versus the Real World in the United States").

The authors point out that the few patients who do join trials do not represent the wide range of U.S. cancer patients. Patients who do enroll in clinical trials tend to be white, younger than 65 years old, and have late-stage cancer, the authors state. This lack of diversity makes it hard to assess how well a new drug might work on other types of patients.

There are many reasons why cancer patients don't join clinical trials. Some of the barriers are financial: doctors don't always tell patients about clinical trials for fear of losing patient revenue to the trial, and insurers don't always cover the cost of clinical trials for patients (although that should change with reform in 2014), explains Betsy de Parry on Candid Cancer ("Low enrollment in clinical trials is hampering progress"). Some barriers are more complex: patients might not live near clinical trial sites, and minority patients might distrust medical authorities, particularly around clinical trials, points out the National Cancer Institute, in a web page on trial participation that is older but still relevant.

The bottom line is that trial participation is inadequate to develop better, potentially life-saving treatments that so many cancer patients need. Information about joining cancer clinical trials is available online at the National Cancer Institute's website.

Can Stem Cells Stop MS?

Later this year, a small clinical trial will begin in Europe to test the use of stem cells to manage or possibly reverse the progress of multiple sclerosis, a disease in which a patient's immune system attacks the myelin sheath that protects nerve cells from damage. The disease tends to first strike when a patient is in their 20s and 30s, and it causes a range of symptoms (which vary widely by patient) such as fatigue, numbness, and balance problems.

For the trial, stem cells will be taken from patients' bone marrow and then injected into their blood, Pallab Ghosh reported for BBC News Health ("Doctors begin major stem cell trial for MS patients"). Promising earlier studies have used these stem cells to "retrain" the patient's immune system not to attack the myelin sheath.

Multiple sclerosis is more common in areas farther from the equator, such as the UK and the northern United States, as this fascinating geographic map of cases illustrates. The incidence of MS appears to be increasing, particularly among women, with some blaming the Western diet and vitamin D deficiency.

Ghosh points out that this trial also aims to address the problem of medical tourism among MS patients, who sometimes seek expensive and unproven stem cell treatments outside the UK. The trial will provide scientific evidence of the efficacy of stem cell treatment.

The phase II trial begins at the end of the year, investigating whether stem cell treatment is effective in human subjects and what side effects it might cause. The trial includes 150 patients and is predicted to take five years, with a possible phase III trial (comparing stem cell treatment to standard MS treatments) to follow before any new treatment can be brought to market.