Thursday, November 8, 2012
Quality clinical trials and 'The Shell Answer Man'
Over the past 37 years in practice, I've received thousands of requests from patients, family and friends to interpret results of clinical trials. These requests have increased dramatically with the advent of the Internet. Many of these reports involve poor trial design or are inappropriate for the patient under consideration. Sometimes I've mumbled to myself "I feel like the Shell Answer Man."
For those too young to remember, I'm referring to a Shell Oil Co. ad beginning in the 1960's in which the 'Shell Answer Man," replete in his Shell gas station uniform, answered common questions about driving and the uses of gas and oil. He just memorized a script; sometimes I wish I had one.
Over Labor Day weekend, while in Chicago for a family event, we turned on TV to catch up on the day's news. As fate would have it, we stumbled upon a health care segment on the NBC affiliate. The reporter was listing items individuals should consider in evaluating results of clinical trials. It seemed to me that knowledge of these items would be very helpful to people who are not healthcare professionals; people who need some way to filter trials worth pursuing with their physicians.
The following are those questions:
1) Are the patients in the trial separated into groups, with one receiving the drug or regimen being tested ("experimental group") while the other is treated with the agent(s) considered standard treatment ("controls")? These groups are many times labeled "arms." The control arm may be a placebo if there is no known standard treatment. This does not mean the patient receives no treatment at all. These types of studies are considered the "gold standard" of clinical trials in that they involve large numbers of patients who are followed for long periods of time. This increases the likelihood that resultant findings are valid. The downside is they take a long time to complete and are very expensive (about $1 billion from start to finish).
2) What is the total number of patients entered into the trial? As alluded to above, the more the better. If one study includes 50 patients while another 350 (all other factors being equal), place more trust in the larger trial.
3) What is the length of the study? In other words, how long are the patients followed? Again, the longer the better.
4) Were the patients included in the trial representative of the proposed population to be studied? For example, if the population to be studied involves pediatric patients, someone over 18 years of age should not be entered into the trial.
5) Who is funding the study? Pay attention here. If the study is paid for by the company who developed the experimental agent, how likely are they to give a completely unbiased report? Of course we want to assume that they will, but unfortunately, some won't. A government supported trial is more likely to report balanced findings than an industry funded one. The reporter added that patients should note what the authors say about their study, i.e., do they make overly optimistic claims for their treatments? Most investigators add some type of cautionary note, like "the proposed treatment looks promising pending further studies." This disclaimer recognizes that no study is perfect. In fact, there has been a marked increase in the number of studies initially reporting positive results that were retracted when similarly designed trials were subsequently negative. The end result has been a delay in patients receiving appropriate treatments and a horrible waste of money.
6) I'm adding this one on my own. I've noticed that one of the most common mistakes people make is to search for clinical trials involving the wrong cancer, not realizing that we identify cancers by their organ-of-origin, not the organ where they spread (metastasize). An example would be to collect articles about liver cancer instead of colon cancer that metastasized to liver.
As chairman of our hospital's Investigational Review Committee, I and our members are in charge of reviewing proposed clinical trials conducted in our hospital district. The above factors, as well as many others, are considered before studies are approved, denied or amendments recommended. Consideration of the items discussed above could save everyone a lot of wasted time, and even lead to the retirement of the Shell Answer Man.
This post by Richard Just, MD, ACP Member, originally appeared at JustOncology.com, a joint publication of Richard Just, MD, aka @chemosabe1 on Twitter and Gregg Masters, MPH, aka @2healthguru on Twitter. Dr. Just has 36 years in clinical practice of hematology and medical oncology.
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