





































 V38 N4 / 2023 

©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     7

THEME ARTICLE

ABSTRACT 
Over the years, multiple reports and editorials have asserted 
that continuing education/continuing medical education 
(CE/CME) that is funded by the pharmaceutical or device 
industry is biased in favor of the funder’s  product(s). But 
starting in the early 2000’s, several stakeholder organiza-
tions began establishing guidance to prevent such bias, and 
currently there are many protections in place. In particular, 
the Accrediting Council for Continuing Medical Education 
(ACCME), the accrediting body for all national organiza-
tions that provide CE/CME, established and continues to 
update specific standards to prevent bias, and all ACCME-
accredited organizations must comply with these and other 
standards to maintain their accreditation in good stand-
ing. A careful review of the literature has identified just a 
few studies that explore the question of bias in CE/CME, all 
published from 2010 – 2012. None of these studies found 
evidence of bias in CE/CME, and no empirical studies on 
the topic have since been published. Thus it seems that the 
protections in place are working, although more rigorous 
and definitive research is needed. Nevertheless, continued 
vigilance is paramount, and medical writers play an import-
ant role in providing oversight of CE/CME by ensuring that 
content they develop is fair and unbiased, as well as accu-
rate and intended to promote optimal patient care.

There is a widespread and persistent assumption that con-
tinuing education/continuing medical education (CE/CME) 
that is supported via educational grants from pharmaceu-
tical or device companies is biased toward the supporter’s 
product or products. But is the assumption fair, and is there 
evidence to support it? What do clinician learners have to 
say? This article explores requirements intended to prevent 
industry bias in CE/CME, published research on bias in CE/
CME activities, and practical steps medical writers can take 
to ensure that CE/CME content is accurate and objective.

CURRENT ACCREDITATION REQUIREMENTS FOR 
PREVENTING COMMERCIAL BIAS
For many years there have been layers of protections to 
prevent commercial bias in CE/CME from various stake-
holders in CE/CME. Protections currently in place include 
codes of ethics (from the Pharmaceutical Researchers 
and Manufacturers of America, the Advanced Medical 
Technology Association, and the American Medical 
Association),1-3 compliance guidance from the Department 
of Health and Human Services’ Office of Inspector General,4 
and accreditation requirements from the Accrediting 
Council for Continuing Medical Education (ACCME).5 With 
regard to CE/CME content, ACCME’s Standards for Integrity 
and Independence in Accredited Continuing Education offers 
the most detailed guidance.5

 The ACCME is the accrediting body for all national orga-
nizations that provide CE/CME. It has a long history of 
concern about commercial influence in CE/CME. The first 
ACCME standards were released in 1992;6 major revisions 
were released in 2004 and again in 2020. The revisions have 
(among other priorities) progressively better defined and 
further restricted industry influence. The most current stan-
dards focus on 5 aspects of CE/CME funding, development, 
and delivery (Table 1); the most relevant for development of 
CE/CME content are standards 1 and 2.

Eve J. Wilson, PhD, FACEHP / Medical Director, PlatformQ Health, Needham, MA

Can Industry-Funded CE/CME Be Unbiased? Current Insights  
on an Old Question

Table 1. The Accreditation Council for Continuing Medical 
Education’s Standards for Integrity and Independence in 
Accredited Continuing Medical Education5

Standard 1 Ensure content is valid.

Standard 2 Prevent commercial bias and marketing in 
continuing medical education.

Standard 3 Identify, mitigate, and disclose relevant 
financial relationships.

Standard 4 Manage commercial support appropriately.

Standard 5 Manage ancillary activities offered in  
conjunction with commercial support.

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AMWAJournal.org     8Can Industry-Funded CE/CME Be Unbiased?

 The content validity standard (Standard 1) holds accred-
ited providers responsible for ensuring their education is fair 
and balanced and supports safe and effective patient care. 
Standard 1 specifies that research discussed in CE/CME 
must “adhere to generally accepted standards of experimen-
tal design, data collection, analysis, and interpretation” and 
that recommendations for patient care must be “based on 
current science, evidence, and clinical reasoning.”5

 Standard 2 requires that all decisions regarding plan-
ning, delivery, and evaluation of CE/CME be made free of 
influence or involvement from “ineligible companies” (for-
merly called “commercial interests”). Ineligible companies 
are defined as those “whose primary business is produc-
ing, marketing, selling, re-selling, or distributing healthcare 
products used on or by patients.” Importantly, ineligible 
companies also cannot recommend, or even suggest, names 
of faculty for CE/CME programs.5

PERCEPTIONS OF BIAS AMONG CLINICIAN 
LEARNERS: WHAT DOES THE RESEARCH SHOW?
To date, numerous reports and editorials have asserted that 
commercial support introduces bias in CE/CME; some have 
even called for a total ban.7-9 But none cite empirical evi-
dence to support bias due to commercial support—perhaps 
because so few studies have systematically examined the 
issue. A careful literature search turned up only 4 studies 
conducted after 2004 (when ACCME first released more  
rigorous standards) that relied specifically on feedback  
from clinicians participating in CE/CME.
 One study examined 95,000 evaluation responses across 
346 CE/CME activities held in 2007 by the Cleveland Clinic 
Center For Continuing Education.10 The analysis found that 
a mean of 98.4% participants responded “yes” (vs “no”) 
to a question about whether the activity was “satisfacto-
rily free” of commercial bias, and a mean of 97.2% partici-
pants responded with “excellent” or “good” to the question 
about the degree to which the activity was free of commer-
cial bias. When analyzed based on commercial support, 
activities were considered free of commercial bias by 98.5% 
of respondents for activities with a single support source, 
98.3% of respondents for activities with multiple support 
sources, and 98.0% of respondents for activities with no 
commercial support.
 A second study examined evaluation responses for 
213 accredited, live educational courses offered by the 
University of California at San Francisco from 2005 to 
2007.11 About 33% of courses had no commercial support; 
the others had varying levels of support. This study found 
that a median 97% of participants perceived no commer-
cial bias (median number of participants per program was 
132). Moreover, no associations were observed between the 

degree of perceived bias and the extent or absence of com-
mercial support.
 A third study looked at perceived bias in evaluations 
from 1,064,642 physician participants in 3,137 Medscape 
online CME activities, of which 28% were supported by 
industry.12 Evaluations asked whether the activity was “pre-
sented objectively and free of commercial bias,” with these 
answer choices: strongly agree, agree, no opinion, disagree, 
or strongly disagree. Overall, just 0.63% of respondents dis-
agreed or strongly disagreed with the statement; that rate 
was slightly higher (0.84%) for commercially supported 
activities and slightly lower (0.48%) for those with no com-
mercial support.
 Interestingly, the fourth study examined perceptions 
of bias in live CME programs that received no commercial 
support, held in 2006, 2007, and 2010.13 More than 1,500 
attendees were asked whether they thought commercial 
support influenced content selection for the overall pro-
gram and for individual lectures. From 6% to 9% responded 
“yes” or “somewhat” across programs; of those who rated 
a program as biased, about 75% also rated one or more 
lecture as biased. These findings speak to a nuance well 
beyond the scope of this article—specifically, that clinicians 
may perceive commercial influence as something beyond 
just commercial support.
 Based on these findings, it seems fair to conclude that 
at least from clinicians’ point of view, commercial bias in 
CME is quite low and independent of commercial support. 
However, more—and more definitive—research is needed. 
In the meantime, it remains crucial to safeguard against 
bias. All those involved in content development, including 
medical writers, must be aware of that potential and work to 
mitigate the risk.

PRACTICAL STEPS FOR MEDICAL WRITERS
Perhaps the 2 most important (and interrelated) concepts 
for medical writers to uphold, vis-à-vis the ACCME stan-
dards, are ensuring content validity and ensuring that con-
tent is fair and balanced.
 Often medical writers work closely with faculty to 
develop CME content. A common approach is for faculty 
to send a set of slides that the writer then organizes, care-
fully fact-checks, and frequently develops further. Another 
approach is for medical writers to craft content that faculty 
then review. Either way, the medical writer must provide 
oversight to ensure the content is accurate and free from 
marketing messages or other commercial influence.
 Regarding content validity, use of appropriate source 
material is key. Sources should include peer-reviewed 
clinical and scientific articles, published preferably in 
high impact factor journals. Published abstracts outlining 

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AMWAJournal.org     9Can Industry-Funded CE/CME Be Unbiased?

research to be presented at medical meetings are often peer 
reviewed and can serve as acceptable references. Posters 
based off these abstracts are generally not peer reviewed, 
but often present the most current information available 
and so may require a judgment call. Other valid resources 
include guidelines or special reports published by govern-
ment sources or medical societies, or textbooks—although 
textbooks may not have the most current information. Many 
medical writers like UpToDate as comprehensive resource 
for clinical care, but it is not suitable as an original source.
 Sources to avoid include blogs, Wikipedia, or other non-
scholarly websites; other CE/CME programs; ineligible 
companies’ websites or press releases; and of course, out-
dated or obsolete references.
 Ensuring that content is fair and balanced means that, by 
ACCME’s definition, information and recommendations or 
emphases in CE/CME “fairly represent” and are “based on a 
reasonable and valid interpretation” of information available 
on the topic.5 The box provides a checklist to help medical 
writers to develop CE/CME content that is fair and balanced.

CONCLUSION
There are many protections against bias in CME; prominent 
among them are the current ACCME Standards. On review 
of published studies, these protections would seem to be 
working, however, more rigorous and definitive research 
is warranted. In the meantime, medical writers can play 
an important role in oversight of CE/CME by ensuring that 
content they develop is fair, balanced, unbiased, and accu-
rate, with a goal of promoting safe and effective patient care.

Author declaration and disclosures: The author notes no  
commercial associations that may pose a conflict of interest in 
relation to this article. Statements and opinions presented in this 
article are the author’s own and do not necessarily reflect those 
of current or past employers or contractors.

Author contact: evejwilson1@gmail.com

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Ensuring CE/CME Content Is Fair and Balanced

•  Use the best available source materials. 
•  Avoid focus on any one treatment.
•  Give equal time to benefits and risks of treatment.
•  Avoid brand names for agents, devices, or procedures;  

if it is necessary to use a brand name for one interven-
tion, then provide brand names for all interventions.

•  Be transparent about emerging therapies, including  
what clinical trial phase they are in.

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