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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Friday, August 21, 2009

TV News is Taking Viewer Opinion to the Extreme

This article also appears in

Sloppy Journalism Can Distort Public Sentiment
I have spoken out about the decline of journalism a number of times. Staff and budgets are shrinking, and the ability of the public to receive well researched news and information is suffering. How are news organizations coping?

One way has been to update and elevate the “man-on-the-street” interview. Used typically to gather some quick reactions from “average” citizens, television news has been devoting an increasing amount of air time to these spots at the expense of real reporting.

With an Internet connection, anyone can become an information source. And anyone can call him or herself a journalist. Some have heralded the arrival of the “citizen journalist” and the gigabytes of “consumer-generated content” as a way to fill the void. I am not one of them. As I’ve said before, citizen journalism is not journalism.

But that opinion doesn’t seem to be shared by television news. They are all eager to receive your emails, YouTube videos, “tweets” and Facebook postings in reaction to the issues of the day. In return, you will get your message posted and maybe even shown or read on the air.

I acknowledge that news and entertainment was converging before this big downturn in the business of journalism, and that this a clever way to engage the audience. Reaching out and obtaining feedback is smart. All businesses need to connect to their stakeholders. But you wouldn’t find a business pulling random customers off the street and putting them on the factory floor or on the phones.

Beyond this being a cheap and easy way to fill some time during a 24-hour day, there’s a more insidious element. Who chooses which comments to air? How are respondents vetted, if at all? Is a balance of opinion sought and, if so, how is it defned? Do the aired responses in any way reflect actual national, regional or local opinion? Does anyone understand how easily bias can be introduced to the news?

My fear is that expediency and a tilt toward showcasing intentionally provocative responses gives a warped portrayal of public opinion. More than just cutting corners or differentiating their broadcasts, this sloppy journalism can give the appearance of an actual poll. I’m all for sharing comments, and exchanging views and information but a more rigorous approach toward 21st century man-on-the-street interviews must be taken to ensure interesting but accurate reporting.
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Thursday, August 13, 2009

Homework for America

Read First, Debate Healthcare Reform Second
Healthcare reform has been discussed since Teddy Roosevelt’s time. We’ve made improvements throughout the years, of course. But they’ve always come with a struggle. The issues and arguments we hear today – excessive cost, loss of choice, the proper role of government – are not new. So, should the Democrats be surprised that some angry people are showing up at their Town Hall meetings?

Probably not. The trend had already been set. Unfortunately, though, we’ve seen an escalation in anger and a decrease in civility at public events over the years. What promised to be a vigorous negotiation over the latest round of healthcare reform proposals has turned into some ugly confrontations. True, America is all about standing up for ones beliefs and having the freedom to do so in public. What we have seen, however, is not a respectful give and take. There’s not nearly enough discourse and debate, and there’s entirely too much ranting and raving. The bottom line is that there’s precious little communicating going on.

Indeed, debate is about putting forth a proposition and allowing a rebuttal. Instead, healthcare reform is being hijacked by a loud minority of citizens who have no actual interest in participating in a productive conversation. For them, it’s not a question of finding a solution, thrashing out a compromise on problematic provisions, or discussing to what extent the government should play a role. It’s about no government. Rather than becoming a rallying point for a common good, healthcare reform has become yet another “wedge issue” like abortion, school prayer or creationism. It’s another example of the polarization of America , the land of the disappearing middle ground, where threats and intimidation can displace rational thought. Agreeing to disagree is becoming less of an option.

When challenged, when asked to stop the heckling, the healthcare reform protesters exclaim “This is America. It’s my Constitutional right!” And, they’re right… to a point. It’s not alright to inhibit the speech of others. We should want debate. We should want to exchange views. We should want the facts. We should want to communicate.

Invoking the Constitution is interesting, though. I’m wondering just how many Americans have actually read it. The protesters should remember that some of its first words are to “form a more perfect union” and to “promote the general welfare.”

So here’s the homework assignment America: read the Constitution. Know what you’re talking about when you use it to defend your rights. And, while you’re at it, read a few good biographies of the “founding fathers.” See for yourselves what their intentions were in creating our United States.

A special homework assignment is given to all of the politicians and political pundits out there. Read the healthcare reform proposals for yourselves before you talk about the potential pluses and minuses. This is for the public good as well as your own (unless you want to be embarrassed by a poor grasp of the facts). For example, over the past few weeks there have been repeated warnings about government “death panels” that will decide who lives and who dies. On former Senator Fred Thompson’s radio show, former New York Lieutenant Governor Elizabeth McCaughey said, “Congress would make it mandatory – absolutely require – that every five years, people in Medicare have a required counseling session that will tell them how to end their life sooner, how to decline nutrition, how to decline being hydrated, how to go into hospice care.” awarded her its “pants on fire” rating for its complete lack of truth. And former Speaker of the House Newt Gingrich was corrected twice by “This Week” host George Stephanopoulis this past Sunday. Mr. Gingrich waved him off and implied that something along those lines were buried somewhere in the 1000+ page proposal. (Again, it’s not.)

I’m hopeful the situation will improve. I saw a good sign at the President’s Town Hall in New Hampshire on Tuesday. The huge crowd was well behaved. Views were expressed, questions were asked and responses were returned. Why the difference? Perhaps people were more deferential toward the President than they were toward members of Congress. Perhaps it was the heavy presence of Secret Service agents. Or, perhaps it was because the attendees were a true cross section of America. Unlike the Town Hall meetings held by members of Congress, people were admitted to the Presidential Town Hall by a lottery – they were randomly selected. Thus, it was impossible to stack the deck with partisans and troublemakers. Whatever the reason(s), let’s continue to communicate knowledgeably, passionately and respectfully.
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