









































       V37 N3 / 2022 

©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     11

ABSTRACT 
Some continuing medical education (CME) activities are 

developed using financial support from entities such as 

pharmaceutical companies that may have a commercial 

interest in the therapeutic area being discussed. Accordingly, 

standards intended to shield CME from industry bias have 

been in place for decades. The latest iteration of these 

standards from the Accreditation Council for Continuing 

Medical Education (ACCME) has a special significance to 

medical writers due to their emphasis on clinical content 

validity. Once a separate entity, the content validity require-

ment is now incorporated into the ACCME standards. In fact, 

it is positioned as the number 1 standard, emphasizing its 

importance. It should be relatively straightforward for writ-

ers to support the goals of the guidance—that is, to provide 

relevant and scientifically accurate content that is free from 

industry manipulation or influence. However, the standards  

as published are not prescriptive in how to achieve these 

goals, leaving writers to ponder exactly what it means to be 

“fair and balanced.” This article provides background on  

the ACCME standards with a special emphasis on their  

relevance to CME writers, describes helpful downloadable 

resources for writers, discusses some scenarios that medi-

cal writers may encounter, and provides practical advice in 

interpreting and applying the current standards when  

developing content for CME activities.

Medical writers are instrumental in the development of 

continuing medical education (CME) content. The key 

opinion leaders and expert faculty members may get pre-

mier placement on the marquee, but it is often the medi-

cal writer (staff or freelancer) generating the manuscript 

text, PowerPoint slides, clinical multiple-choice questions, 

interactive patient cases, animation storyboards, video and 

podcast scripts, and other scientific content that helps drive 

improvements in clinician knowledge, competence, and 

performance.

 These CME writing assignments are often rigid and flex-

ible at the same time. Medical writers may be asked to stay 

within the guardrails of preexisting learning objectives and 

content outlines, and their work is typically subject to multi-

ple reviews by faculty experts, peer reviewers, and CME pro-

viders. Even so, writers often find themselves in the position 

of making high-level decisions regarding content direction, 

often entirely on their own, or with a minimum of guidance.

 The nature of CME content decisions that medical writers 

tackle independently can vary widely. One day, it’s selecting 

citable peer-reviewed sources for a PDF monograph on best 

practices in diabetes management. The next day, it’s describ-

ing the complexities of therapeutic selection in a PowerPoint 

deck on relapsed/refractory multiple myeloma—a disease 

state in which (at last count) there were 30 reasonable mul-

tidrug regimens to choose from, depending on the number 

and type of previous treatments given.1

 This task of content decision making becomes even 

more challenging when writers consider the potential 

for bias in the materials they are developing. Many CME-

related writing assignments are to provide content for activ-

ities that are supported—that is to say, developed using a 

financial grant from a company or companies that likely 

have a commercial interest in the therapeutic area. Thus, 

direct industry support for an activity is a potential source 

of bias (although not the only source, eg, faculty may have 

their own conflicts of interest that need to be resolved).

 Although data from the Accreditation Council for 

Continuing Medical Education (ACCME) indicate that the 

vast majority of accredited educational activities (upwards 

of 90%) receive no commercial support at all, the total sum 

of grant funding is nevertheless large. Accredited providers 

have reported more than $700 million per year in commer-

cial support since 2016 with a grand total of nearly $723 mil-

lion in 2020, the most recent year for which this statistic is 

available.2

 With those kinds of numbers in mind, medical writers 

have a considerable responsibility to help ensure that sup-

ported CME content is scientifically sound and devoid of 

industry manipulation or influence. Toward that end, stan-

dards have been promulgated by the ACCME, the nonprofit 

Andrew D. Bowser, ELS, CHCP  /  IconCME, Philadelphia, PA

Avoiding Bias and Ensuring Content Validity in Accredited Continuing  
Education: What Do the Latest ACCME Standards Mean for Medical Writers?

CE CRAFT CORNER

http://www.amwajournal.org


AMWAJournal.org     12Avoiding Bias and Ensuring Content Validity

that accredits organizations that offer CME and recognizes 

state medical societies as accreditors of local CME programs.

NAVIGATING COMMERCIAL INTERESTS
The first set of ACCME standards intended to guide the CME-

industry relationship was released in 1992, and in 2004, more 

stringent standards were put in place to ensure the indepen-

dence of CME activities, particularly with regard to conflict 

of interest. The latest iteration, “Standards for Integrity and 

Independence in Accredited Continuing Education,”3 was 

released in December 2020 and has been adopted by 7 addi-

tional accrediting bodies across multiple health professions. 

As of January 1, 2022, all providers in the ACCME system are 

expected to comply with the new standards.

 Medical writers should take note of how content valid-

ity is central to the new ACCME standards (Table 1). In a 

Viewpoint published in JAMA, ACCME President Graham 

McMahon, MD, MMSc, explained that content validity 

requirements had been part of ACCME policy for many 

years, but separately from the standards. Now, McMahon 

said, content validity is included as the very first standard, 

which was intentionally done to emphasize its significance: 

“With the proliferation of medical misinformation and  

disinformation, as well as questions about the validity of 

science, issues related to content validity are more import-

ant than ever.”4

 In a nutshell, the expectations for content validity are as 

follows:

• Recommendations for patient care have to be based 

on current scientific evidence and clinical reasoning 

while providing a fair and balanced view of options for 

diagnosis and treatment.

• Any scientific research used to support or justify a 

patient care recommendation has to conform to  

generally accepted standards for study design, data 

collection methods, analysis, and interpretation.

• Although discussion and debate are appropriate, the 

education can’t advocate or promote practices that  

are not firmly based on current scientific evidence  

and clinical reasoning.

• On a related note, the education cannot advocate for 

unscientific approaches or medical practices that are 

known to be ineffective, or have risks that outweigh 

the benefits.

APPLYING THE ACCME STANDARDS
Those requirements may sound straightforward on paper, 

but they are sometimes challenging to apply in actual day-

to-day medical writing practice. The ACCME does offer 

some helpful general advice on best practices (Table 2) 

along with a helpful peer review checklist available for 

download. For example, multiple perspectives can be  

Table 1. New ACCME Standards for Integrity and Independence in Accredited Continuing Education

Standard Applicability Accredited Provider Responsibility

1. Ensure Content is Valid All accredited CE Ensure that education is fair and balanced, and that any clin-
ical content presented supports safe, effective patient care 

2. Prevent Commercial Bias and  
Marketing in Accredited CE

All accredited CE Protect learners from commercial bias and marketing in 
accredited CE

3. Identify, Mitigate, and 
Disclose Relevant Financial 
Relationships

All accredited CE Identify relevant financial relationships between 
individuals in control of educational content and ineligible 
companiesa and managing these to ensure they do not 
introduce commercial bias

4. Manage Commercial Support 
Appropriately

Accredited CE that receives 
financial or in-kind support 
from ineligible companies

Ensure that the education remains independent of the 
ineligible company and that the support does not result  
in commercial bias or commercial influence

5. Manage Ancillary Activities 
Offered in Conjunction With 
Accredited CE

When there is marketing by 
ineligible companies or nonac-
credited education associated 
with the accredited CE

Ensure that education is separate from marketing by 
ineligible companiesb and from nonaccredited education 
offered in conjunction with accredited continuing 
education

CE, continuing education.
aAn ineligible company is a company ineligible to be accredited in the ACCME system; their primary business is producing, marketing, selling, re-selling, or 
distributing health care products used by or on patients.
bIncludes advertising, sales, exhibits, and promotion.
Adapted from Standards for Integrity and Independence in Accredited Continuing Education. Copyright 2020 by the ACCME.

http://www.amwajournal.org


AMWAJournal.org     13Avoiding Bias and Ensuring Content Validity

provided to address a clinical question in which there is 

considerable debate (eg, “should routine colorectal cancer 

screening begin at age 45?”).5

 However, many questions remain that are not necessar-

ily covered in detail in formal guidance. For example,

• If one treatment is discussed in detail, does that mean 

others need equal coverage in order to be fair and  

balanced?

• What if there is only 1 relevant treatment for a specific 

disease state covered in the education?

• Is it strictly forbidden to use brand names for drugs? 

And if so, what do I do when the use of generic 

descriptors is overly complicated or confusing?

• Can I cite a company press release? And if not, how 

do I properly cite research that apparently hasn’t been 

published or presented yet?

 I consulted several medical writers and others with CME 

experience (see Acknowledgement) to review possible 

solutions to these and other issues. A summary is below. 

First, however, it’s important to emphasize that it is gener-

ally not all on the medical writer’s shoulders to parse out 

difficult situations regarding fair balance, potential conflicts 

of interest, or other issues. On the contrary, it is the accred-

ited provider of the educational activity that is ultimately 

responsible for ensuring that the overall activity is in align-

ment with the ACCME standards. The staff of the accred-

ited provider should be skilled and experienced in applying 

the ACCME standards and can be an excellent resource for 

anyone who is involved in CME content creation or execu-

tion. Accordingly, writers are strongly encouraged to reach 

out to the accredited provider for the activity when they are 

unsure how to proceed. Ideally, this would occur early on 

rather than later in the content development process, espe-

cially so that carefully crafted content isn’t unexpectedly 

sidelined by content revision needs at the last minute.

 Although the following tips should not be taken as 

gospel or unassailable expert advice, they may offer a path 

forward that may be acceptable for your dilemmas regard-

ing content validity:

Provide fair balance—but not necessarily equal time. 
Although it’s important to avoid focusing on a specific treat-

ment and to discuss efficacy as well as safety data, there is 

no need to discuss each treatment option with exactly the 

same emphasis. Let the strength of evidence and US Food 

and Drug Administration (FDA)-approved indications guide 

the weight of discussion. For example, 2 treatments for a 

specific dermatologic condition may appear to have simi-

lar rates of response and tolerability, although upon closer 

inspection, the evidence for treatment A is from a random-

ized, placebo-controlled phase 3 trial, whereas treatment 

B is supported by a single-arm phase 2 trial. Furthermore, 

treatment A may have a specific FDA indication for the der-

matologic condition, whereas treatment B is used off-label 

to treat the condition (off-label use is common and some-

times necessary, but the education should be upfront about 

that, and ideally refer to the evidence supporting the unap-

proved usage).6 High-quality review articles and clinical 

practice guidelines may offer clues in terms of cataloging 

the evidence to date, although caution is advised in relying 

on stale information, particularly in fast-moving areas like 

immuno-oncology in which new data are always a meeting 

away (or less).

 In some cases, a therapeutic area may be so under-

served that there is only 1 relevant emerging or novel treat-

ment option (eg, in a rare disease in which the previous 

standard of care was supportive care). In that case, provid-

ing fair balance may be a discussion of emerging therapeu-

tic options in earlier stages of clinical investigation. Failing 

that, balance can be provided by ensuring adequate discus-

sion of the potential risks of therapy alongside the potential 

benefits (as is good practice for CME writing in any case).

Table 2. New ACCME Standards for Integrity and Independence 
in Accredited Continuing Education

Focus Area Recommendation

Level of Evidence Clearly describe the level of evidence 
on which the presentation is based 
and provide enough information 
about data (study dates, design, etc.) 
to enable learners to assess research 
validity

Sources Ensure that, if there is a range of 
evidence, that the credible sources 
cited present a balanced view of the 
evidence 

Recommendations If clinical recommendations will be 
made, include balanced information 
on all available therapeutic options

Risks and Adverse 
Effects

Address any potential risks or adverse 
effects that could be caused with any 
clinical recommendations

Evidence Base If the evidence base is low (or absent) 
for a topic or treatment, consider 
alternate strategies, eg, a debate or 
dialogue between multiple faculty 
representing a range of opinions and 
perspectives

Adapted from the Toolkit for the Standards for Integrity and Independence 
in Accredited Continuing Education. Copyright 2020 by the ACCME.

http://www.amwajournal.org


AMWAJournal.org     14Avoiding Bias and Ensuring Content Validity

Cite credible and acceptable sources. Experienced CME 
writers generally recognize a hierarchy of evidence and 
sources, although caveats apply at each level:

• Peer-reviewed and PubMed-indexed medical jour-
nal articles are usually considered highly citable, but 
some judgment is required on the part of the writer, 
as not all peer-reviewed research is of high quality, 
and not all journals are as impactful as others (did that 
promising-looking study end up in the New England 
Journal of Medicine or in a little-known journal?).

• Clinical practice guidelines also rank high, particularly 
if provided by well-known medical societies or orga-
nizations (such as the American Heart Association), 
although not all guidelines are rigorously developed. 
Look for methodologies such as the GRADE (Grading 
of Recommendations, Assessment, Development, and 
Evaluations) system, which can be used to evaluate 
evidence quality and quantify the strength of health 
care recommendations.7

• Medical meeting presentations are generally consid-
ered fair game. However, the information in a meet-
ing abstract may not be peer reviewed. In addition, 
the conclusions of the research may change substan-
tially from the submission of a meeting abstract to the 
actual meeting presentation, and sometimes, to the 
subsequent publication of those results in a peer- 
reviewed journal.

• Many agree that company press releases are not 
appropriate to cite, although as a result, it can be tricky 
to develop a state-of-the-art CME presentation when 
a potentially practice-changing clinical trial result is 
available only in the form of a press release. Although 
there are no easy solutions, one approach may be to 
reference publicly available details of the clinical trial 
design (eg, from the ClinicalTrials.gov database) and 
state in the activity that published/presented results 
are awaited.

Avoid corporate logos and (usually) brand names. When 
it comes to avoiding industry influence in CME activities, 
it’s a no-brainer to omit corporate logos, and it’s consid-
ered best practice to eschew brand names—although this is 
not always straightforward or without challenges. Medical 
devices, biosimilars, and proprietary formulations of 
common drugs are just 3 of the categories of products that 
are sometimes difficult to discuss without dropping brand 
names. The COVID-19 vaccines present a new wrinkle, as 
they are widely referred to by the manufacturer’s name, so 
many learners won’t immediately know whether the Pfizer 
mRNA vaccine is BNT162b2, mRNA-1273, or Ad26.COV2.S 
(it’s BNT162b2). Finally, some audiences may know a  

specific drug only by its brand name, making education 
based on generic names an uphill battle. If the brand name 
can’t be avoided, make sure to apply the standard equally, 
for example, don’t use a brand name for one drug and a 
generic name for the others.

Don’t forget about the other standards. Content validity 
is just 1 puzzle piece (although an important one) in the 
new ACCME Standards for Integrity and Independence 
in Accredited Continuing Education. There are important 
intersections between this guidance and the medical writ-
er’s work. Writers should make sure that disclosure infor-
mation, including their own, is provided in the activity they 
are developing (Standard 3: Identify, Mitigate, and Disclose 
Relevant Financial Relationships), and may need to solicit 
that information if it’s not already available. Another exam-
ple: a faculty member tries to add a PowerPoint slide that 
their local drug rep said would be “just perfect” for the 
accredited activity; the writer should decline and remind 
faculty that decisions regarding the education must be 
made without influence or involvement from pharmaceuti-
cal company employees (Standard 2: Prevent Commercial 
Bias and Marketing in Accredited CE).

CONCLUSION
Medical writers are often on the front lines of develop-
ing accredited continuing education. Accordingly, writers 
must help ensure that the fundamental principles of integ-
rity and independence govern the development of spe-
cific educational activities. Toward that end, writers should 
have a thorough working knowledge of the latest ACCME 
Standards for Integrity and Independence in Accredited 
Continuing Education. Reviewing available ACCME 
resources (including the aforementioned guidance and 
checklist for clinical content validity) will help writers apply 
the standards to their current projects and navigate some of 
the nuances described in this article. With that background, 
medical writers will be better prepared to develop clinical 
CME content that is fair and balanced, unbiased, and sup-

portive of safe and effective patient care.

Acknowledgement
The author thanks the following individuals for their 

insights and perspectives on the topic of this article:

• Esther L. Langmack, MD, FCCP, CHCP, Langmack 

Medical Communications LLC

• Jan Schultz, MSN, RN, FACEHP, CHCP, Jan Schultz 

Associates

• Alexandra Howson MA, PhD, CHCP, Thistle Editorial, 

LLC

http://www.amwajournal.org
http://ClinicalTrials.gov


AMWAJournal.org     15Avoiding Bias and Ensuring Content Validity

• Eve Johnson Wilson, PhD, CHCP, FACEHP, 

PlatformQ Health

• Donald Harting, MA, MS, ELS, CHCP, Harting 

Communications LLC

Author declaration and disclosures: The author notes no  
commercial associations that may pose a conflict of interest in 
relation to this article.

Author contact: abowser@iconcme.com

References
1.   National Comprehensive Cancer Network. Multiple Myeloma. 

Version 5. National Comprehensive Cancer Network; 2022. 
Accessed April 28, 2022. https://www.nccn.org/professionals/
physician_gls/pdf/myeloma.pdf

2.   Accreditation Council for Continuing Medical Education. 
ACCME Data Report: Rising to the Challenge in Accredited 
Continuing Education - 2020. ACCME; 2021. Accessed April 
28, 2022. https://www.accme.org/sites/default/files/2021-
06/902_20210615_2020%20Data%20Report.pdf

3.   Accreditation Council for Continuing Medical Education. 
Standards for Integrity and Independence in Accredited Continuing 
Education. ACCME; 2020. Accessed April 28, 2022. https://
accme.org/sites/default/files/2021-06/884_20210624_New%20
Standards%20Standalone%20Package.pdf

4.   McMahon GT. Changes to the Standards for Integrity and 
Independence in Continuing Medical Education. JAMA. 
Published online April 15, 2021. doi:10.1001/jama.2021.0213

5.   Wender RC. Should routine screening for colorectal cancer start  
at 45 years of age? Yes: lowering the starting age is a settled issue. 
Am Fam Physician. 2022;105(2):120–121.

6.   United States Food and Drug Administration. Understanding 
unapproved use of approved drugs “off label.” US Food and Drug 
Administration website. Updated February 5, 2018. Accessed 
May 19, 2022. https://www.fda.gov/patients/learn-about-
expanded-access-and-other-treatment-options/understanding-
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7.   Brozek JL, Akl EA, Alonso-Coello P, et al. Grading quality of 
evidence and strength of recommendations in clinical practice 
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RESOURCES

• ACCME Standards for Integrity and Independence in 

Accredited Continuing Education (PDF)

• Toolkit for the Standards for Integrity and 

Independence (in particular, pages 7-8, “Guidance for 

Planners, Authors, and Faculty: Ensuring that Clinical 

Content is Valid”)

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http://www.amwajournal.org
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https://accme.org/sites/default/files/2021-06/884_20210624_New%20Standards%20Standalone%20Package.pdf
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