amwa indiana chapter newsletter 2014 july
DESCRIPTION
ÂTRANSCRIPT
Indiana Chapter NewsletterJuly 2014
NewsletterExecutive Committee 2013-2014
Let us know if there is anything we can do to helpyou benefit professionally from your AMWAmembership. Volunteering to help our chapter ornational association is a great way to have funwhile meeting some wonderful people, improvingyourself and the profession, and becoming andbeing the leader you were meant to be. Join ourLinkedIn group, come to the chapter events, orclick on the name of a chapter officer orcommittee chair above to join the conversationabout medical communication and our chapter.
Officers
Committee Chairs
Barbara Lightfoot, BS, CCRPGregory Adams, IIEllen Stoltzfus, PhD
Laura Town
Esther Brooks-Asplund, PhD
David Caldwell, PhDLinda Hughes, MA
Editor
Section Editors
David Caldwell, PhD
Esther Brooks-Asplund, PhD
Gregory Adams, II
Svetlana Dominguez, ELS
William Pietrzak, PhD
Esther Brooks-Asplund, PhD
Ellen Stoltzfus, PhDQing Zhou, PhD
Links
AMWA
Please let us hear your voice!
AMWA LinkedIn
AMWA Indiana Chapter
AMWA Indiana Chapter LinkedIn
LG Hughes Blog
PresidentPresident-ElectSecretaryTreasurer
Education
Member ResourcesProgram
PublicationsSocial Media
Editing
Freelance
Medical Device
Pharmaceutical
Publication
Karen Roberts
Global English for Everyone Blog
Wednesday through Saturday, October 8 - 112014 AMWA Annual Conference
Location: Memphis, TN
Coming Attractions
AMWA Twitter AMWA Facebook
Pam McClelland, PhD
Gregory Adams, II
July 2014 | AMWA Indiana Chapter Newsletter | 3
Contents
Find AMWA members near you by searching the AMWA member directory by city or zip code.
This map of the locations of our 101 chapter members was created with BatchGeo.
An Editor Can Add Value to a Scientific GrantPatti L. Raley, MTSC, ELS
Regulatory Affairs Scientist Wins AMWA’s FirstTwitter Hashtag Contest
Indiana’s Medical Device Industry: Opportunities forMedical Writers (Part III)
William S. Pietrzak, PhD
Cover
My Career as an EpidemiologistTammie L. Nelson, MPH, CPH
Linda G. Hughes, MA
2014 AMWA Indiana Chapter Conference SummaryDavid Caldwell, PhD4
11131722
4 | AMWA Indiana Chapter Newsletter | July 2014
2014 AMWA Indiana Chapter Conference Summary
David Caldwell, PhD ([email protected])
Keynote Address: Why Isn’t Alzheimer’s Cured Yet?
Ann Hake, MD
Five drugs are available for treating the symptoms of Alzheimer’sdisease (AD) but none for treating AD itself. Researchers have ahard time trying to rationally study and cure AD because theydon’t yet know what its physical structure is – no animal naturallymodels the disease and the only definitive diagnosis of AD inhumans requires autopsy. So they are asking five intuitivequestions to help them learn how to diagnose, modify, or preventthe disease: what is the function (good or bad) of beta amyloidplaques (extracellular clumps of brain cell protein associated withAD); does regulation of tau protein cause or prevent plaques andneurofibrillary tangles (intracellular snarled threads of tau proteinassociated with AD); does preventing brain inflammation preventAD; does AD prevent natural regeneration of neurons; and is AD aform of diabetes resulting from defective mitochondria.Researchers are also exploring the familial genetics of AD andsearching for sensitive and reliable biomarkers of the disease.
Panel: Special Ethical Issues in Vulnerable Populations
Peter Schwartz, MD, PhD; Mary Ott, MD, MA; Amy Waltz, JD; EricFelde (moderator)
Ethics of clinical research is all about informed consent, aboutgiving patients information they need to decide whether to
Chapter Conference Summary
Editor’s Note: The conference was held June 6 and 7 at The ColumbiaClub in Indianapolis. An asterisk denotes a summary written by theconference speaker. Greg Adams summarized April Lavender'spresentation. Photos are courtesy of Bill Pietrzak, PhD, KarenRoberts, and Linda Hughes, MA.
July 2014 | AMWA Indiana Chapter Newsletter | 5
participate in a study. How do we create a document that makesthem aware of the side effects and risks of participating in a studyif they have a diminished ability to decide whether to participateor if they don’t like numbers and want something more thaninformation? Should we create a “learning health care system” inwhich the same standards of informed consent apply to bothmedical treatment (such as routine surgery) and to a clinical trial?Panelists discussed these and related questions in the context ofthe Surfactant, Positive Pressure, and Oxygenation RandomizedTrial (SUPPORT).
Healthcare Brand Journalism: Connect with Your Audience
Through Storytelling*Linda G. Hughes, MA
Conference goers learned how social media provides the stage toput a human face on healthcare issues. Participants also gainedinsight into how relevant, authentic, unbiased stories that developan emotional connection and engagement can lead to more of theconversations you want. Registrants attending this interactivesession completed exercises as if they were bloggers for a day,since a blog is the center of an online newsroom. [Slides of Linda'spresentation are available on the chapter Web site.]
Chapter Conference Summary
6 | AMWA Indiana Chapter Newsletter | July 2014
Life as a Freelance Juggler (of Deadlines and Clients)*
Eric Metcalf, MPH
Eric Metcalf shared some insight on how to thrive as a freelancerthat he discovered over his career, both as an in-house writer for apublishing company and as a self employed writer and radioproducer. The principles he credited with keeping him busy wereto: always be diversifying (from your job skills to the type ofoutlets you work with to the geographic location of your clients);get to know as many industry contacts as possible; seek out workenvironments guarded by a high barrier to entry; and identify withyour skills, not your job title.
The Orthopaedic Regulatory and Clinical Affairs (ORCA)
Graduate Program at Grace College*Allyn Decker, MA; David Kreider, MS
Allyn Decker (ORCA Program Director) and David Kreider(AMWA member and Medical Writer at Zimmer, Inc.) provided aninformational session on Grace College's unique, industry-focusedgraduate program in Orthopaedic Regulatory and Clinical Affairs(ORCA). Mr. Decker provided a slide presentation overview of theone-year, accelerated master's program that equips professionalsto support medical device development through regulatorysubmissions, compliance, after-market surveillance, and clinicalstudy supervision. Mr. Kreider, a 2012 graduate of the ORCAprogram, provided a student’s perspective and highrecommendations for this cutting edge program.
Chapter Conference Summary
July 2014 | AMWA Indiana Chapter Newsletter | 7
Current Trends in U.S. and Global Regulatory Submissions for
Medical Devices
April Lavender, RAC
April Lavender, the senior vice president of regulatory affairs atCook Medical, gave an overview of the global regulatory landscapein the medical device industry. She talked about the challenges inkeeping up with and meeting fast-changing regulatory andcompliance requirements around the world, such as the OpenPayments Act in the United States and the French Sunshine Act.She also discussed the risk classifications and approval processesfor devices and offered some ideas for areas in which regulatoryrequirements could be streamlined or adjusted to benefit patientsand industry.
Copyright and Trademark Law
Brad Maurer, JD
Copyrights, which last for the life of an author plus seven years,give the author the right to exclude others from using tangibleforms of her or his work without permission. A trademark, whichcan last forever, is a legally protectable symbol (e.g., words, printeddesign, product design, packaging, sound, smell, texture, or taste)that uniquely identifies your goods or services to the public. Slidesof this presentation describing these intellectual properties andtheir benefits to medical writers are available upon request fromMr. Maurer ([email protected]).
Strategies for Expediting Review of New Medicines*
Esther Brooks-Asplund, PhD
The FDA embodied its 1988 thinking about expediting theavailability of promising new drugs and biologics for serious
Chapter Conference Summary
8 | AMWA Indiana Chapter Newsletter | July 2014
Chapter Conference Summary
conditions (21 CFR 312, subpart E) in four programs—breakthrough therapy (2012), priority review (1992), acceleratedapproval (1992), and fast track (1997)—detailed in the 2013 FDAGuidance for Industry: Expedited Programs for SeriousConditions – Drugs and Biologics. Likewise, the FDA embodiedthe 1983 Orphan Drug Act and corresponding rules (21 CFR Part316), which promote development of new therapies for thetreatment of rare diseases or conditions, by establishing the Officeof Orphan Products Development. (Sponsors apply for orphandesignation in both the US and EU through FDA form 3671 11/11.)Of the 27 drugs and biologics approved by the FDA in 2013, 15(56%) were approved through the first three programs (Mullard A.2013 FDA drug approvals. Nat Rev Drug Discov. 13(2): 85-89; 2014)and 9 (33%) were approved through the orphan program; sponsorsreceived 70 fast track designations (FDA-TRACK).
How to Maximize Acceptance of Your Manuscript in a Peer-
Reviewed Journal*William S. Pietrzak, PhD
Peer-reviewed journals are extremely selective in what theypublish making it imperative for medical writers to understandmeans to increase their chances of acceptance. The nuances of thepeer-review process were described, the mind-set of reviewers wasdiscussed, and effective approaches to responding to the editor'sdecision, be it "revise" or "reject", were examined. Real-worldexamples were provided for illustration.
From Medical Editing to Business Logistics: How Transferable
Skills Can Enhance Your CareerSvetlana (Lana) Dominguez, BA, ELS
Give others your best and give yourself room to move bydeveloping skills (such as negotiation, critical thinking, project and
July 2014 | AMWA Indiana Chapter Newsletter | 9
Chapter Conference Summary
time management, and the ability to see the big picture or to dealwith shades of gray) needed for many different careers. For helpwith identifying your skills, take a look at these resources:
Marcus Buckingham, Donald O. Clifton. Now, Discover Your Strengths.The Free Press, 2001.
Tom Rath. StrengthsFinder 2.0 (from Gallup’s Now, Discover YourStrengths). Gallup Press, 2007.
Transferrable Skills Checklist: Rouge Community College
Transferrable Skills: Bringing Your Skills to a New Career
How to Identify Your Transferrable Skills.
Chapter Conference Committee Members
Laura Town (conference organizer; chapter education chair)Ellen Stoltzfus, PhD (committee member; chapter secretary)Barbara Lightfoot, BS, CCRP (committee member, chapter president)
10 | AMWA Indiana Chapter Newsletter | July 2014
Chapter Conference Summary
Lunch at The
Columbia Club
Conversation with
new and old friends
July 2014 | AMWA Indiana Chapter Newsletter | 11
Contest Winner
Regulatory Affairs Scientist Wins AMWA’s First
Twitter Hashtag Contest
Linda G. Hughes, MA ([email protected])
Zhengbin “Justin” Xu, PhD, follows the US Food and DrugAdministration (FDA) on Twitter. So, Justin hears their news beforeothers who only visit the FDA website. “It’s very convenient. And Ican get the newest thinking earlier, on the go, wherever I am,” saysthe regulatory affairs scientist at MED Institute in West Lafayette.
Smartphones. Forget the name, they’re only as bright as youprogram them to be. This biotechnology whiz kid has hissmartphone serving as a mind-reading personal assistant. Hemutes his phone so he doesn’t hear FDA notifications while he’sworking. Then when he’s ready, he checks the queue or messagesin reminders for FDA updates. During a normal working day, hegets about five tweets from the FDA and he might check one ortwo of them.
“For me, Twitter is a time-saving way to screen the most importantinformation,” says the China native. Justin says he can quicklyscreen out what is most important or what he wants to follow upon.
Thanks to the Internet, anybody can publish. But he says nobodycan ever read everything, not even everything they’re interestedin. So, Justin bookmarks articles he likes. Then whenever he comesacross a problem or an issue, he’ll remember reading somethingabout that on Twitter and he’ll search for that information again.
The patent-holding inventor wants to stay informed aboutimportant things, so he follows top experts as they have a higherprobability of influencing our lives. You’ll be the first to get news ifyou follow the right people on Twitter.
Justin learnsFDA news on
his phoneearlier, on the
go
Contest winnerZhengbin “Justin”Xu
12 | AMWA Indiana Chapter Newsletter | July 2014
Contest Winner
Justin also likes the character limit on Twitter, a concise 140characters. This keeps the Purdue Boilermaker focused on themost important information. Then he doesn't have to spend a lotof time deciding what he wants to say when he tweets.
Congratulations, Justin, for winning AMWA’s first hashtag contestin its history. The hashtag #amwainoh giveaway promoted ourchapter conference in June. I'm working with AMWA now to scalethe promotion for the 74th Annual Conference in Memphis,October 8-11. So, Twitter account holders, stay tuned to@AmMedWriters and hashtag #AMWA14.
Zhengbin “Justin” Xu, PhD ([email protected]) is a regulatory affairsscientist at MED Institute, Inc. in West Lafayette.
Linda G. Hughes, MA is a healthcare brand journalist at LG Hughes,LLC in Indianapolis.
Indiana Chapter Conference Survey
We appreciate all of you who attended our 2014 chapter conference at the ColumbiaClub. To better understand and meet your needs next year, please take five minutes tocomplete and return this survey by email ([email protected]) or anonymously bymail (see the survey).
Chapter Conference Workshop Leader
Susan Aiello, DVM, ELS (editor-in-chief of The Merck Veterinary Manual; medicalpublishing consultant and trainer; winner of AMWA's Golden Apple Award for teachingexcellence)
Workshops: Organizing the Medical Paper, and Sentence Structure and Patterns
You’ll be thefirst to getnews if youfollow theright peopleon Twitter
July 2014 | AMWA Indiana Chapter Newsletter | 13
Grant Applications
An Editor Can Add Value to a Scientific Grant
Application
Patti L. Raley, MTSC, ELS ([email protected])
What Is a Grant?
Have you heard about grant proposals, but are not sure what theyare? While many types of grants are available for purposes thatspan the arts, education, humanities, and sciences, this brief articleprovides a glimpse into grants for scientific research,characteristics of effective grant proposals, and ways an editor canadd value to the grant application process.
A clinical or basic scientist writes a grant proposal to requestmoney to do research and submits it to an agency that may fundthe work. If the proposal receives funding, then the scientist beginsthe research project described in the proposal. At the end of theproject, the scientist writes and submits a final report to the groupwho provided the funding. The scientist also will write and publisha manuscript to share the results of the project in a peer-reviewedjournal. These results give rise to more research questions thatbegin a new cycle of grant writing.
Depending on the requirements of the funding agency, agrant proposal may be a simple letter, a brief, 3- to 5-pagedescription of the project, or a more complex application thatincludes a 15- to 20-page description of the project, along withmany forms and appendices. The following links will take you tosites that list available grants, requirements for applying,application deadlines, and the process for submitting documentselectronically.
• Proposal Central (smaller agencies and foundations):https://proposalcentral.altum.com/.
• Grants.gov (large government grants):http://www.grants.gov/web/grants/search-grants.html.
14 | AMWA Indiana Chapter Newsletter | July 2014
Grant Applications
Research scientists who need large grants to fund long-termprojects often apply to government agencies, such as theDepartment of Defense (DOD) or the National Institutes of Health(NIH). The following links will take you to NIH sites where youmay explore the types of grants and the application process:
• National Institutes of Health (NIH):http://grants.nih.gov/grants/guide/index.html?CFID=51636574&CFTOKEN=24157527&jsessionid=f630ba89216f73efb0451c565d682662a595
• NIH grant process:http://grants.nih.gov/grants/grants_process.htm#process.
Grant Proposals Must be Clear, Succinct, and Compelling
Regardless of the type of grant or the amount of fundingrequested, a grant must describe the project clearly and succinctlywithin a strict page limit. The description must be compellingenough to convince reviewers to fund the project. Because theapplication process is competitive and many people apply, onlythe most persuasive proposals receive funding.
The audience for a grant proposal is a review committee. At aprivate foundation, an internal committee will review theapplications. These reviewers are people who sit on the board ofthe organization and who may or may not be scientific experts. Ata large agency, such as NIH, scientific experts from the profession-at-large review grant applications and score each proposalaccording to a set of criteria. In addition to a score, these reviewersprovide feedback about the strengths and weaknesses of theproposal. Proposals with a favorable score and feedback receivefunding. To aid reviewers, a grant proposal must be free ofdistractions such as typographical errors, faulty syntax, andawkward language.
Only the mostpersuasiveproposals
receivefunding
July 2014 | AMWA Indiana Chapter Newsletter | 15
Grant Applications
How Can an Editor Add Value to the Grant Process?
Typically, the scientist who will conduct the project writes thegrant. However, scientists have many more responsibilities thatinclude preparing progress reports and manuscripts for previousprojects, conducting research, teaching, consulting, and attendingand presenting at conferences. They can benefit from having aneditor review their grants before submitting them. Here are waysan editor can add value to a grant application:
• An editor can ensure the grant adheres to the specificationsfor font, type size, page length, margins, and figure formats.
• An editor can review the description of the project, also calledthe narrative, to ensure that the writing is clear and concise.The narrative tells the reviewer why, what, how, and whenthe project will be conducted. The quality of the narrative iscritical for helping the grant reviewer decide whether tofund the project.
• If an author’s first language is not English, an editor may needto do additional editing to ensure clear, succinct writing.However, an editor needs to be cautious: edit for clarity, butbe careful to maintain the author’s style throughout thenarrative. Use of queries is a good strategy for suggestingalternative phrasing or word choices. With grants, it isimportant to let the author choose.
• An editor can help by preparing the nontechnical descriptionsof facilities and equipment in required templates. Thisinformation can be used in other grants.
• An editor can prepare brief biographical descriptions, alsocalled biosketches, from lengthy curricula vitae. A specificformat or template may be required for biosketches.
• If a proposal deadline is looming and time is limited, an editorwho can do an excellent job of proofreading may be ofimmense help. Reviewers of proposals are detail-orientedand many are editors of journals—the little things will jumpout at them. They may forgive a long paragraph or anoccasional awkward sentence, but they may reject aproposal that has too many misspelled words ortypographical errors.
The quality ofthe narrative
is critical
16 | AMWA Indiana Chapter Newsletter | July 2014
Grant Applications
Because grants are a major source of funding for researchscientists, a grant that is clear, succinct, and compelling will have abetter chance of being funded. Well-written grant proposals alsowill enhance the scientist’s credibility, which, in turn, will makereviewers look forward to future grants from the same person.Your own credibility as a grant editor will build over time. One ofthe highest compliments—and a testament to the value an editorcan add—is to receive a comment from a reviewer who thought aproposal was extremely well edited and is worthy of being funded.
Patti Raley has been a biologist, a scientific writer, and a medical writersince the 1980s. She has been a board-certified editor in the life sciencessince 1996. She now reviews and edits grants and manuscripts fortraumatic brain and spinal cord injury research at the IU School ofMedicine.
Volunteer?AMWA exists only because medical communicators like you volunteer tobuild and maintain their profession. Our chapter offers lots ofopportunities to meet interesting people, share your wisdom, learn moreabout our profession, and improve your leadership skills. Distance is notan obstacle; most volunteer activities can be performed electronically.Don’t worry about whether you know enough to participate – you do! Ifyou would like to join in the fun and help our chapter while helpingyourself, please let our incoming president, Greg Adams([email protected]), know as soon as possible.
A clear,succinct,
compellinggrant has a
better chanceof beingfunded
July 2014 | AMWA Indiana Chapter Newsletter | 17
Clinical Device Evaluation
Indiana’s Medical Device Industry: Opportunities
for Medical Writers (Part III)
William S. Pietrzak, PhD ([email protected])
The April (2014) issue of the AMWA Indiana Chapter Newslettersummarized several of the more common types of services thatmedical writers perform for the medical device industry. The firstone that was described, i.e., Clinical Evaluations, will be examineda bit more in-depth here.
In a nutshell, foreign countries typically require documentedclinical evidence that supports the safety and performance of amedical device before it can be sold, or can continue to be sold, inthat country. The European Union (EU) represents one of thelargest foreign markets for medical devices. As such, preparingClinical Evaluation Reports (CERs) for the EU is one of theprimary functions of medical writers in the device industry andwill be our focus here.
The EU Medical Device Directive (2007/47/EC revision to MedicalDevice Directive 93/42/EEC) was established to provide theharmonized standards to be met for a manufacturer to legallyplace a medical device on the European market. In general, themanufacturer prepares a Design Dossier which is a large,multisection document that provides the required information,with the CER being one of the sections. The Design Dossier isreviewed by a Notified Body, which is an accredited third-partyorganization. Following successful review, the Notified Body willissue an EC Design-Examination Certificate, which states that thedesign conforms to the requirements of 93/42/EEC and thenenables the manufacturer to place the CE Mark on the device sothat it can be sold and distributed in the EU. Once the CE Mark isobtained for a new product, the story is not over. The CE Markwill still require subsequent CERs in the future to support CEMark renewals at 5 year intervals.
Preparingclinical
evaluationreports is a
primaryfunction of
medicalwriters in the
deviceindustry
18 | AMWA Indiana Chapter Newsletter | July 2014
Clinical Device Evaluation
Per the MDD, devices are classified according to risk, in the orderClass I < Class IIa/b < Class III. Class III device CERs requireNotified Body approval. CERs written for Class I and IIa/b devicesare maintained in the medical device company’s technical files,which can be audited by the Notified Body. It is important to befamiliar with MDD Annex I which lists the Essential Requirementsthat must be considered in the context of the medical device beingevaluated.
MEDDEV 2.7.1 Rev 3 (December, 2009) provides the guidelinespertaining to the creation of CERs which are defined as ‘theassessment and analysis of clinical data pertaining to a medicaldevice in order to verify the clinical safety and performance of thedevice’. (See also MDD Annex X.) The CER is meant to be acomprehensive, objective evaluation of the clinical performanceof the device based on clinical data available in the public domainas well as that contained within the company. So as not to beredundant with the guidance provided in MEDDEV 2.7.1 Rev 3, Iwill focus on some lessons learned after years of writing andreviewing CERs as well as dealing with Notified Bodies.
It is important to remember that many medical devices are part ofcomplex systems that can include implants of various sizes andconfigurations, as well as the instruments required to surgicallyplace them. As such, it is important to describe the device(s) withsufficient detail and clarity so that the reviewer gains sufficientunderstanding to be able to make sense of the rest of thedocument. The CER should have a beginning, middle, and an endso that it logically flows to the conclusion. Whereas the conclusionideally will be that the device(s) is safe and performs as expected,with a favorable risk/benefit ratio, you must go where the datatakes you and should not work backward from your desiredconclusion.
The types of clinical data to consider include peer-reviewedpapers obtained through a PubMed and/or Google Scholar search,the complaint and sales history obtained within the company, andinternal data regarding IDE (Investigational Device Exemption)
Rememberthat many
medicaldevices are
part ofcomplexsystems
July 2014 | AMWA Indiana Chapter Newsletter | 19
Clinical Device Evaluation
studies or post-market studies. In the case of total jointreplacement devices (arthroplasty), many countries have nationaljoint registries that provide data on usage and survivorship thatshould be consulted. Some of this information will be provided toyou by others within the company such as sales data from thepost-market surveillance department, clinical study data from theclinical department, complaints from the complaint department,etc. You may obtain some of the information yourself, byperforming PubMed searches, obtaining the papers, andsummarizing and evaluating the studies. How much clinicalevidence you obtain yourself or is provided to you by others willdepend on how your company is structured. In any event, it willbe beneficial for you to create a generic checklist to help ensurethat you don’t inadvertently overlook a piece of clinical evidencefor your CER.
Ideally, one would want to have long-term (10-year) clinical dataavailable for the Subject Device. However, if there is little dataavailable, then one or more Equivalent Devices will have to beidentified and compared to the Subject Device per MEDDEV 2.7.1Rev 3 to establish such equivalence. Then clinical evidence for theEquivalent Devices can be used as a surrogate for the SubjectDevice. It is important, however, to critically examine thedifferences between the Subject Device and Equivalent Device andsuggest how these differences may, or may not, affect the clinicalperformance.
Many medical devices have multiple indications listed on theirPackage Inserts or Instructions for Use. Ideally, clinical evidenceshould be presented on behalf of each of the indications. It can bedifficult, though, to find clinical data on each indication all of thetime. However, if a sound clinical argument can be made thatsuggests one of the indications is “worst case”, then clinicalevidence for that indication may be sufficient for the “lesser”indications as well, but this is a grey area.
When evaluating the disparate types of clinical evidence that areobtained, it is not uncommon to come across a study whereby the
Criticallyexamine thedifferences
between thesubject device
andequivalent
device
20 | AMWA Indiana Chapter Newsletter | July 2014
Clinical Device Evaluation
outcomes were poor and/or there was a large complication profile.While such negative studies must be included in the CER, it isimportant to not minimize them, but rather, objectively evaluatethem and build them into the fabric of the CER. Such negativestudies should be scrutinized closely. It may be the case that theresults were negative because the patient population was especiallychallenging, e.g., elderly, with significant co-morbidities, or beingin an otherwise severely compromised state. Discussing this in theCER will help put the negative results into perspective and canhelp the reviewer understand the extenuating circumstances.
While the various types of clinical data are often placed in theirown sections of the CER, e.g., one section for complaints, one forsales data, one for the literature search, one for literaturesummaries, etc., it is important that all of this data be integratedand cross-referenced toward the end of the CER to tell acompelling, well-documented story of safety and performance. Ilike to call this the “30,000 foot view”.
After the CER is written, it is helpful to have it reviewed by otherswithin the company to ensure that it is both comprehensive andclear, and that nothing was inadvertently omitted.
Once the Design Dossier, which contains the CER, is submitted theNotified Body has 90 working days to respond. There are ways tospeed up the process, such as a fast-track review, expedited review,or on-site review by the Notified Body, but these incur additionalcosts.
It is typically the exception, rather than the rule, that the NotifiedBody will accept the CER without any questions. More commonlythere were will be questions regarding the Design Dossier ingeneral and the CER in particular. It may take multiple rounds ofquestions and responses before all issues are finally closed.Sometimes you may not understand the question. In that case, itcan be beneficial to place a call to the reviewer and obtainclarification. Eventually, you will have a CER that is accepted bythe Notified Body. But you won’t be able to get comfortable for
Tell acompelling,
well-documented
story of safetyand
performance
July 2014 | AMWA Indiana Chapter Newsletter | 21
Clinical Device Evaluation
long, because you likely have a backlog of several more CERswaiting for you to write!
As a final note, it is apparent that much coordination andinteraction between various groups within the device company isrequired for the medical writer to properly write a CER. This ischallenging enough for a medical writer employed by the devicecompany. It is even more challenging for an outside medicalwriter, either freelance or from an agency, since that writer istypically off-site. As such, it is important that there be someone atthe company that is primarily responsible for gathering andsending the input data to the outside writer, with the writer havinga listing of key contacts (e.g., Engineering, Marketing, Clinical,Regulatory, etc.) within the company to directly interface withshould questions or issues arise.
Additional references
Achakri H, Fennema P, Udofia I, Generating clinical evaluationreports. A guide to effectively analysing device safety andperformance. BSI/UK/417/ST/0314/en/HL
Tariah I, Pine R, Effective post-market surveillance. Understandingand conducting vigilance and post-market clinical follow-up.BSI/UK/440/ST/0614/en/HL
William Pietrzak is a research scientist at Biomet, Inc. and an adjunctresearch professor of bioengineering at the University of Illinois atChicago.
Coordinationand
interactionbetween
groups withinthe companyis required to
write a CER
22 | AMWA Indiana Chapter Newsletter | July 2014
My Career as an Epidemiologist
Tammie L. Nelson, MPH, CPH ([email protected])
As a graduate student working toward a career in clinical medicine,I learned of an upcoming presentation about the IndianaUniversity School of Medicine’s public health program (now theIU Fairbanks School of Public Health). I attended with an interestin learning more, and found myself excited about the possibility ofimproving population health, as compared to caring for a subset ofpatients in clinic. I pursued further information, finally decidingthat public health was a better match for me.
I chose the path towards epidemiology for the same reasons I hadpursued medicine—to study the cause, effect, and patterns ofdisease, and to support the development of evidence-basedstrategies by which to address threats to population health.William Foege (Epidemiologist credited with the strategy leadingto smallpox eradication) called epidemiology the “Scientific base”1of public health and the data-rich, evidence-based, multidisciplinefocus satisfies me intellectually. In other words, I get to geek-out!
Most organizations require that their epidemiologists hold at leasta Master’s degree. My degree is a Master of Public Health, withepidemiology as my study concentration. In further preparation, Icompleted two doctoral level epidemiology courses on studydesign and advanced biostatistical methods, as well as severalprogramming and writing courses (both technical and medical).Experience with advanced statistical software is essential. In myexperience, SAS is the software of choice. It is used exclusivelywithin my organization, as well as among others with which I havecollaborated. Finally, while not yet required, public healthpractitioners may sit for a qualifying board exam in order to setthemselves apart from others in the field. I earned my CertifiedPublic Health credential and complete mandatory continuingeducation units in order to maintain it.
Epidemiologist
Epidemiologyis the
scientific baseof public
health
July 2014 | AMWA Indiana Chapter Newsletter | 23
Epidemiologists typically have a specialty area in which they focus.My primary area of expertise is HIV/AIDS, sexually-transmittedinfections (STI), and their related comorbidities. In addition tomorbidity and mortality throughout the Indianapolis-CarmelMetropolitan Statistical Area, I investigate and report on socialdeterminants, behavioral risk factors, and interventions; racial,ethnic, and socioeconomic disparities; and, availability andutilization of core medical and supportive services for peopleliving with HIV/AIDS. My duties in these areas include datacollection; providing quality control over complex databases;epidemiological and situational analyses; preparing variousreports; providing health department staff and communityorganizations with information needed for decisions that affecthealth throughout Central Indiana; developing and assistingdevelopment of research projects and special studies; serving assubject matter expert for internal and external stakeholders; and,supporting various grants.
While it may sound as if I pore over data at every availablemoment, that is not the case. Some of my time is spent workingwith external stakeholders and community-based organizationsdelivering educational/awareness presentations and/or datarequired for external grants. I offer consultations on study designand program evaluation. I also, of course, write and edit. Some ofthese activities are for routine or ad hoc reports and grants. Thebulk of my writing in this position so far, however, has been as co-author of our Ryan White Part A, Minority AIDS Initiative, andPart C grant applications each year, some of the largest grantsawarded to the health department ($4-$4.5 million annually).
If you would like to know more about epidemiology, or publichealth in general, feel free to contact me.
1 Foege, W.H. (2011). House on fire: The fight to eradicate smallpox. (1st ed.).University of California Press. p. 16.
Epidemiologist
Epidemiologiststypically
specialize
24 | AMWA Indiana Chapter Newsletter | July 2014
Tammie Nelson is an epidemiologist with the Marion County PublicHealth Department (3901 Meadows Drive, H108 Indianapolis, IN 46205Tel: (317) 221-3556).
Thank You!We sincerely thank our education committee for planning ourexcellent 2014 Indiana chapter conference: Laura Town (chair),Sarah Felde, Barbara Lightfoot, Rachael Mann, Kit Solotkin, andEllen Stoltzfus.
Special thanks to:
The Columbia Club (who squeezed us in without their typicalrequired notice);
Markey’s AV (who, without being contracted/compensated,went above and beyond the call of duty to help peoplepractice their talks);
Jennifer Kost-Barker (who served as our workshop proctorand on-point hospitality person);
Eric Felde (who lined up our Friday panelists);
Susan Aiello (who led two workshops); and
All open session speakers and roundtable leaders (LauraTown, Greg Adams, and Laura Oberthur Johnson).
Epidemiologist