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A Workshop by Dr. Nancy J Stark
Available Now on CD
Clinical Evaluations—for Europe and the States
Clinical evaluations are required in Europe to justify the design of new clinical investigations and to apply for certification and CE Marking from Notified Bodies. Literature evaluations are required to justify the use of animals in biological safety testing or in preclinical studies.
In the States, clinical evaluations have been a staple of technology assessments from the Agency for Healthcare Research and Quality (AHRQ) at www.ahrq.gov for years. Take a look at the technology assessment for negative pressure wound therapy devices (http://www.ahrq.gov/Clinic/ta/negpresswtd/references.htm#ref65) to get an idea of the complexity of a comprehensive clinical/literature evaluation. AHRQ plays a pivotal role in obtaining Medicare reimbursement in the States; their reports are reviewed by the the Centers for Medicare and Medicaid who, in turn, make reimbursement decisions.
In 2010, AHRQ received $500,000,000 to conduct comparative effectiveness reviews of existing drugs, devices, and biologics. Take a look at a recently published draft assessment titled "Comparative Effectiveness of Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women" (http://effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/comment-draft-reports/?pageaction=displaydraftcommentform&topicid=202&productid=770&documenttype=draftReport). This document compares stress electrocardiography, echocardiography, single proton emission computed tomography, cardiac magnetic resonance, and computed tomography angiography—all medical device technologies with an established history of use. The reviewers point out that of the 98 studies reviewed not a single one was a randomized, controlled trial (RCT).
Independent "interested parties" are welcome to submit their own data, publications, assessments, reviews, or other documents during the draft period of these publications. I highly recommend that medical device manufacturers do so.
A How-to Workshop on CD
Clinical evaluations are going to have a major impact on the availability of both new and old technologies to European and American patients. And medical device manufacturers should arm themselves with clinical trials and clinical evaluations so that systematic reviews are fair, balanced, and not only written by other people. You can read more about clinical evaluations on my whitepapers blog (http://clinicaldevice.typepad.com/cdg_whitepapers/2011/09/literature-evaluations-for-biological-safety.html), but to get serious help on writing a clinical evaluation you should purchase the "Clinical Evaluations Workshop" on CD.
You will learn
[✔] When literature reviews and clinical evaluations are required in Europe and in the States.
[✔] What are the major "how-to" and regulatory documents.
[✔] Who should be on the clinical evaluations team.
[✔] How to select objectives.
[✔] How to identify key questions and keywords.
[✔] What are the suggested key questions.
[✔] How to select and search databases.
[✔] Educational but unusable databases.
[✔] How to manage citations in an Excel spreadsheet.
[✔] How to do a manual search.
[✔] How to filter abstracts.
[✔] A source for efficiently retrieving full-text articles.
[✔] How to appraise (value) and weight (add up the values) of full-text articles.
[✔] How to evaluate the literature.
[✔] How to apply the risk management principles of ISO 14971.
[✔] How to appraise sponsored clinical studies.
[✔] How to compile the clinical evaluation; including format and content.
[✔] Quality assurance steps.
[✔] How to do a biological safety literature evaluation.
[✔] A proposed evaluation strategy.
[✔] The regulatory logic behind clinical evaluations.
[✔] Metrics.
You will recieve
[✔] PowerPoint slides (as pdf).
[✔] An expert 3-4 hour recorded presentation by Dr. Nancy J Stark.
[✔] How-to standard ISO 10993-01 (2009) Annex C.
[✔] How-to document GHTF SG5 "Clinical Evaluation".
[✔] How-to guidance MEDDEV 2.7.1 r3 "Clinical evaluation: a guide for manufacturers and notified bodies" (2009).
[✔] How-to AHRQ "Methods Guide for Effectiveness and Comparative Effectiveness Reviews" (2008).
[✔] AHRQ Technology Assessment for Negative Pressure Wound Therapy (2010).
[✔] Medicare coverage statement for NPWT.
[✔] Literature Review Flowchart.
[✔] Risk Management Flowchart.
[✔] 93-42-EEC (2007) regulatory logic.
[✔] 90-385-EEC (2007) regulatory logic.
[✔] A 15-question quiz.
[✔] Opportunity for feedback.
[✔] One certificate and 0.4 CEUs.
For a small, additional fee you may obtain templates for this required documentation:
[✔] Procedure, protocol, and template for clinical evaluations, provided in Word and completely editable so you can make them your own.
Presenter
Dr. Nancy J Stark is President and founder of Clinical Device Group, a CRO and consulting firm that has been in business since 1990. Her curriculum vitae can be found at www.nancystark.com.
System requirements
[✔] Personal computer.
[✔] Adobe Media Player 1.8 (http://help.adobe.com/en_US/AdobeMediaPlayer/1.8/Using/index.html).
Best regards,
Nancy J Stark, PhD
President, Clinical Device Group Inc