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Why clinical trial recruitment is so hard, and one solution: Patient education

Aug 14, 2015

Clinical trials are the lifeblood of the life sciences industry – yet less than 5 percent of adult cancer patients will pursue experimental therapies. The biggest reason for this? Fear:

"Although the backbone of today’s successful cancer treatments, clinical trials are poorly understood by the public, often viewed as treating people like guinea pigs instead of as giving them the best chance for survival," a piece today in the New York Times says.

The article is patient-centric and patient-geared: It serves as a much-needed call-to-action for the many would-be clinical trial participants. Such patient education efforts are really critical in helping bump up enrollment figures – which ultimately get that biologic, small molecule or miracle stent approved and on the market.

An article from OncLive outlines the different challenges in clinical trial recruitment:

  • Fear: Patients are afraid of being placed in the placebo docket, and thereby missing treatment entirely.
  • Stigma: Clinical trials are shrouded in stigma. Patients look at clinical trials as last resort options – and often believe that a drug’s more legit if it’s got the FDA stamp of approval.
  • Confusion: Clinical trials can be complicated and confusing, and refusing the paperwork, the routines and the possible travel are far easier an option than going ahead with an experimental therapy.
  • Insurance: Patients may get the run-around from insurance companies on whether these trials will be covered. Despite protections in the Affordable Care Act, insured patients might be concerned of unexpected costs – and many don’t know what rights they have within their plans.
  • Burden: Patients are worried about burdening their families, and will often choose the easiest course of treatment, even if it isn’t the best one.

There's hope, though, and a precedent of success:  Parents of children with cancer are far more likely to pursue experimental therapies -- and it's paid dividends.

"The outcome in children is so stunning because 80 to 90 percent of young patients participate in clinical trials," Siddhartha Mukherjee, author of the Pulitzer Prize-winning book, "The Emperor of All Maladies: A Biography of Cancer,"told the New York Times. "Every trial taught doctors something that led to further trials and better results."

A 2008 paper in Lancet Oncology attributed "this high level of engagement" to the "so-called therapeutic alliance that begins between doctors and families when a child is diagnosed with cancer." In the patient education game, pediatric specialists are interfacing more effectively with parents than adult docs are with their own patients. So how do you expand this success rate to the much larger adult cancer patient set? The OncLive piece suggests:

"Everyone agreed that communication and education were essential in overcoming the fear-based patient and family barriers to clinical trials. Some specific approaches, mostly focused on healthcare professionals’ involvement, included the following: Provide all the treatment options, including eligible clinical trials, to the patients and their families. Involve them in the decision-making, and engage everyone in the conversation. Recognize that all healthcare professionals have a role in recruitment, including oncologists, nurses, surgeons, social workers, and primary care providers. Educate patients so that they know that clinical trials offer a type of treatment rather than a placebo."

A strong patient education agenda should be budgeted into every life sciences company’s product development plan. Interfacing with both doctors and patient communities is key.

And articles like today’s in the NYT help. They allow the greater public a more transparent view of clinical trials, and how they work. Having this enter the greater dialogue should slowly encourage patients to become willing trial participants.

For more information or to see the original article in medcitynews.com, click here.