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.
Labels: evidence-based medicine, guest post, JustOncology, patient communication, research, Richard Just
posted by Richard Just, MD at
9:00 AM
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Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:
Albert Fuchs,
MD
Albert Fuchs, MD, FACP, graduated from the
University of California, Los Angeles School of Medicine, where he
also did his internal medicine training. Certified by the American
Board of Internal Medicine, Dr. Fuchs spent three years as a
full-time faculty member at UCLA School of Medicine before opening
his private practice in Beverly Hills in 2000.
And Thus, It Begins
Amanda Xi, ACP Medical
Student Member, is a first-year medical student at the OUWB School
of Medicine, charter class of 2015, in Rochester, Mich., from which
she which chronicles her journey through medical training from day
1 of medical school.
Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and
general internist in the Division of General Internal Medicine at
Johns Hopkins. His research interests include doctor-patient
communication, bioethics, and systematic reviews.
Controversies in Hospital
Infection Prevention
Run by three ACP
Fellows, this blog ponders vexing issues in infection prevention
and control, inside and outside the hospital. Daniel J Diekema, MD,
FACP, practices infectious diseases, clinical microbiology, and
hospital epidemiology in Iowa City, Iowa, splitting time between
seeing patients with infectious diseases, diagnosing infections in
the microbiology laboratory, and trying to prevent infections in
the hospital. Michael B. Edmond, MD, FACP, is a hospital
epidemiologist in Richmond, Va., with a focus on understanding why
infections occur in the hospital and ways to prevent these
infections, and sees patients in the inpatient and outpatient
settings. Eli N. Perencevich, MD, ACP Member, is an infectious
disease physician and epidemiologist in Iowa City, Iowa, who
studies methods to halt the spread of resistant bacteria in our
hospitals (including novel ways to get everyone to wash their
hands).
db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating
medicine and the health care system.
DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about
health topics for patients and health professionals.
Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more
than a decade and is an Associate Professor of Medicine at an
academic medical center on the East Coast. His time is split
between teaching medical students and residents, and caring for
patients.
Everything
Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science,
medicine, health and healing in the 21st century.
FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the
Internal Medicine Residency and Assistant Dean of Scholarship &
Discovery at the Pritzker School of Medicine for the University of
Chicago. Her education and research focus is on resident duty
hours, patient handoffs, medical professionalism, and quality of
hospital care. She is also an academic hospitalist.
Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings
of medical practice and the complexities of hospital care,
illuminates the emotional and cognitive aspects of caregiving and
decision-making from the perspective of an active primary care
physician, and offers behind-the-scenes portraits of hospital
sanctums and the people who inhabit them.
Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the
University of North Carolina School of Medicine, and the Program
Director for the GI & Hepatology Fellowship Program. He
specializes in diseases of the esophagus, with a strong interest in
the diagnosis and treatment of patients who have
difficult-to-manage esophageal problems such as refractory GERD,
heartburn, and chest pain.
I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an
interest in basic and clinical science and education, with
interests in noninvasive monitoring and diagnostic testing using
novel bedside imaging modalities, diagnostic reasoning, medical
informatics, new medical education modalities, pre-code/code
management, palliative care, patient-physician communication,
quality improvement, and quantitative biomedical imaging.
Informatics
Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical
Informatics & Clinical Epidemiology, Oregon Health &
Science University, posts his thoughts on various topics related to
biomedical and health informatics.
David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned
authority on nutrition, weight management, and the prevention of
chronic disease, and an internationally recognized leader in
integrative medicine and patient-centered care.
Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of
hematology and medical oncology. His blog is a joint publication
with Gregg Masters, MPH.
KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites
for influential health commentary.
MD
Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of
medical practice, including controversies in the doctor-patient
relationship, medical ethics and measuring medical quality. When
he's not writing, he's performing colonoscopies.
Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics
in medicine, health care news and culture. Her views on medicine
are informed by her past experiences in caring for patients, as a
researcher in cancer immunology, and as a patient who's had breast
cancer.
Mired in MedEd
Alexander M.
Djuricich, MD, FACP, is the Associate Dean for Continuing Medical
Education (CME), and a Program Director in Medicine-Pediatrics at
the Indiana University School of Medicine in Indianapolis, where he
blogs about medical education.
More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice
internist, returns with "volume 2" of his personal musings about
medicine, life, armadillos and Sasquatch at More Musings (of a
Distractible Kind).
Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a
small community hospital in Connecticut. His blog is a series of
musings on medicine, medical care, the health care system and
medical ethics, in no particular order.
Reflections of a Grady
Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being
a doctor in a community hospital in Atlanta.
The Blog of Paul Sufka
Paul Sufka,
MD, ACP Member, is a board certified rheumatologist in St. Paul,
Minn. He was a chief resident in internal medicine with the
University of Minnesota and then completed his fellowship training
in rheumatology in June 2011 at the University of Minnesota
Department of Rheumatology. His interests include the use of
technology in medicine.
Technology in (Medical)
Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in
education, social media and networking, practice management and
evidence-based medicine tools, personal information and knowledge
management.
Peter A. Lipson,
MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and
teaching physician in Southeast Michigan. The blog, which has been
around in various forms since 2007, offers musings on the
intersection of science, medicine, and culture.
Why is American Health Care So Expensive?
Janice
Boughton, MD, FACP, practiced internal medicine for 20 years before
adopting a career in hospital and primary care medicine as a locum
tenens physician. She lives in Idaho when not traveling.
World's Best Site
Daniel Ginsberg, MD,
FACP, is an internal medicine physician who has avidly applied
computers to medicine since 1986, when he first wrote medically
oriented computer programs. He is in practice in Tacoma,
Washington.
Other blogs of note:
American Journal of
Medicine
Also known as the Green Journal, the American Journal of Medicine
publishes original clinical articles of interest to physicians in
internal medicine and its subspecialities, both in academia and
community-based practice.
Clinical
Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP
Member, associate program director at New York University Medical
Center's internal medicine residency program. Faculty, residents
and students contribute case studies, mystery quizzes, news,
commentary and more.
Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so
he can create an independent, clinician-reviewed space on the
Internet for physicians to report and comment on the medical news
of the day.
PLoS Blog
The Public Library of Science's open access materials include a
blog.
White Coat
Rants
One of the most popular anonymous blogs written by an emergency
room physician.
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