Friday, August 28, 2009

Moving the Needle on Clinical Trial Recruitment

Poor Communication is Among the Obstacles to Research
The passing of Senator Ted Kennedy has come to dramatize many things, like the importance of representing all stata of society and the need for new voices of compromise in the Congress. And, the necessity of further advancements in cancer therapeutics.

Senator Kennedy died of glioblastoma, one of those cancers that goes tragically hand-in-hand with “death sentence.” He had the best care available but, obviously, it wasn’t nearly good enough. There have been advancements, of course. Survival for this particular form of cancer has improved from about four months to about 15 since President Nixon’s famous 1971 declaration of a “war” on cancer.

The change has been incremental. A big obstacle to the discovery of truly breakthrough medicines has been the maddeningly complex nature of the disease. There is hope, however, that our ever-increasing understanding the molecular biology of tumors will lead to new interventions.

But that brings us to another big obstacle. When new, experimental therapeutics are available, they must be tested in clinical trials to ensure that they meet agreed upon standards of safety and effectiveness in people. The problem is that there is a chronic shortage of patient volunteers. Currently, there are more than 6,500 cancer clinical trials available (most trying to fine-tune cocktails of existing drugs) yet only three percent of adult patients agree to participate. In a recent article in The New York Times (“Lack of Study Volunteers Hobbles Cancer Fight”), Gina Kolata reported that “more than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result.”

The article cited a number of reasons for this low participation rate, among them: oncologists not wanting to refer patients away from their practices, reimbursement headaches, record-keeping and staff requirements and patients wanting to avoid any additional hassles.

Then, there’s fear. Even with Institutional Review Boards checking the ethics of study protocols and crafting of extensive Informed Consent documents, patients worry about being guinea pigs. They worry about getting a placebo instead of the active agent, even though the vast majority of studies only use the current standard of care and the investigational product. For some, tragedies of the past are proof of what can go wrong. The Tuskegee study (looking at the long-term effects of untreated syphilis in African-American men) and the Atomic Energy Commission study (that gave pregnant women radioactive iron but were told it was a “vitamin cocktail”) continued into the 1970s. That’s recent history for some of us.

Another barrier to patient recruitment is just a plain lack of information – most patients (and many physicians) are unaware of the existence of clinical trials that might be appropriate for them. It has been reported that 85 percent patients and 31 percent of physicians lack sufficient information about available studies. For those who were aware of trials, the top reason for refusing to participate was concern over their privacy and confidentiality (according to the Institute of Medicine).

Professional and patient advocacy organizations, the National Institutes of Health, hospitals and biopharmaceutical companies all promote clinical trials in some form or another, and try to communicate privacy safeguards. Now, Pfizer is taking a new step to address these impediments to research progress. They announced a partnership with Private Access to allow patients to “be more quickly and precisely matched to appropriate clinical trials while simultaneously protecting their confidential personal health information.” This on-line platform is planned for introduction late this year.

This could be an important, innovative step but perhaps a small one. A Harris Interactive survey in 2007 showed that the public’s confidence that their health records will be kept confidential is already fairly high. Seventy percent of respondents agreed that they are “generally satisfied with how their personal health information is handled with regards to privacy protections and security.”

So, where are the gaps? What else can be done to help convince patients to participate in clinical trials?

1. Clearly, we must keep communicating and educating – keep pushing the rock up the hill. The word must continue to get out with information targeted to the audience.

2. The process must be made as simple as possible – simple to understand for the patients and simple to administer for the study coordinators. And, some of the trials and their reporting requirements must be simplified. Not slackened – simplified. I have consulted on a number of patient recruitment projects and, after reviewing the protocol, and surveying the investigators, study nurses and the study population, have told the sponsors on a number of occasions that their study is just too complicated, just too onerous. First, sharpen the objectives and focus on what is truly important. Then, find ways to cut down on the number of office visits, the number of needle sticks, whatever.

3. The “what’s in it for me” question must also be addressed for all the parties involved. What would it take to get more physicians to refer their patients? What changes to reimbursement need to be made? What can be said to patients and their families so that they better understand their contribution, and feel more connected to the study and its outcome? What new incentives can be created to ensure that investigators don’t just sign on to the protocol but actively recruit study volunteers?

We can’t expect to achieve all that we want by attempting to address just one piece of the patient recruitment puzzle. We need to look at these issues – including privacy – together to really move the needle.
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1 comment:

Paul Oestreicher said...

Quintiles, the large CRO, just announced a new effort to attract clinical trial volunteers. You can read about it in this article published in R&D Directions: