qd Solutions Blog
What’s going on at qd Solutions and rattling around in our brains

Adapting to more personalized clinical research

This is a great article from the Wall Street Journal about a new approach to clinical trials called “adaptive design.”  It allows researchers to look at study results much earlier in the process, enabling researchers to steer later-enrolling patients into studies where they may receive the most medical benefit based on the genetic profile of their disease.  It’s a more personalized version of clinical research, which, as it expands, will have a positive effect on the image of clinical trials among prospective patients.

Posted by qd_admin on October 27th, 2010 :: Filed under Clinical Trials,Health Care

Nothing “incidental” about a clinical trial test result

Earlier this year, a good friend of mine had appendicitis.  During his time in the emergency room, he received a CAT scan, which confirmed the diagnosis, and he went into surgery.

The day he checked out of the hospital, his doctor came by.  While the appendectomy had gone well and my friend was healing well, the doctor had additional news – in addition to the appendicitis, the CAT scan had also revealed a spot on one of his kidneys.  Was it a tumor?  The doctor recommended he follow-up on it and referred him to another doctor.

In a recent article (and follow-up editorial) in the Archives of Internal Medicine, found here, the question was raised whether medical research participants should be notified of “incidental findings” that turn up on radiological reports but are unrelated to the research study’s intent.  Say you’re in a heart study and a chest scan (as required by the study’s protocol) indicates a spot on one of your lungs.  The debate was whether you should be told about the lung finding.  Maybe the person reading the radiology results isn’t really qualified to interpret them beyond the study parameters.  Or perhaps it’s a false-positive that will give you unneeded stress and require many other tests, which come with their own risks to you.  So, should you be told?

Are you kidding me?

One of the hesitations that people have about participating in clinical trials is the perception that the research is not really interested in the patient’s health, but rather in getting the data about the investigational medicine.  This is largely untrue.  But even to question the true motive hints that perception might sometimes be reality in this case.

While the primary purpose of medical research is gaining information about the investigational treatment, patients should feel (and truly realize) that they are getting the highest level of medical care by volunteering.  To suggest otherwise only undermines efforts to get more people to participate in medical research.  There should be no dilemma here – the patient should be told of the findings and provided resources for follow-up.  That extra bit of health security will only enhance the medical research experience in the eyes of the public.

As for my friend, thank goodness the doctor did say something.  It was a tumor on his kidney, necessitating more surgery.  Because of the appendicitis (it could have just as easily been an incidental finding in a clinical trial test), the tumor was caught early and my friend is now making a full recovery.

Posted by qd_admin on September 30th, 2010 :: Filed under Clinical Trials,Health Care

When friends ask about “reform.”

Friends who know I work with the pharmaceutical industry quiz me often about what healthcare reform means for our business.  It’s a loaded question, and one that can generate a slew of follow-up questions.

Here’s what I know:  According to the Center for Information and Study on Clinical Research Participation (www.ciscrp.org) and the US Census, National Vital Statistics, new medicines generated 40% of the gain in life expectancy over the past 25 years.  That’s a lot when you think how much health-conscious the country has become during that time, with reductions in smoking, increased exercise, and better overall health education.  And yet according to annual data for 2006 compiled by the Centers for Medicare and Medicaid Services (CMS),  just 10 cents of every dollar (or 10%) spent on health care went to medicines.

That’s quite a disparity.  Does that mean they should be equal – more of the healthcare dollar should be spent on medicines to match its impact on life expectancy?  Of course not.  But the value of new medicines and their impact on the quality of our lives shouldn’t be dismissed in the process.

So what will healthcare reform, in whatever “form”, ultimately mean for us?  It’s hard to say.  Given the gains in life expectancy, I’m not sure why anyone would want to make it harder for people to develop new medicines.  Yes, drug companies need to discover new medicines because it’s the product they sell.  But more than that, the clients we work with are good people.  They have families who are impacted (and sometimes devastated) by health issues just like everyone else.  They come to work every day not thinking only about the dollar, but thinking about the people they’ll someday help – children and adults who want to live longer, normal, healthy lives.  And no amount of legislation will ever change that.

Posted by qd_admin on April 12th, 2010 :: Filed under Advertising,Clinical Trials,Health Care
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