CDG e Conferences & Workshops

How to Write A Clinical Evaluation

A Workshop by Dr. Nancy J Stark
Available Now on CD

 Available at: http://www.clinicaldevice.com/mall/Workshops.aspx.

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.

Additional Items
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

 

  

 

 

 

        

CRO Capabilities from Clinical Device Group

CRO Services from Clinical Device Group -- Click for Help
Clinical trials are not designed by one person, they take a team. Consider the big-ticket items you need:
[1] Project Management,
[2] Investigator's Brochure or Report of Prior Investigations,
[3] Study documents,
[4] Pre-IDE meeting with FDA (optional but recommended),
[5] Approvals,
[6] Study conduct.

On average, a new clinical trial takes 6-9 months to initiate; as much as 75% of your clinical trial labor will be spent on study start-up. You'll need people from toxicology, regulatory, clinical research, manufacturing, marketing, and R&D to pull this all together.

CDG's Biological Safety Rescue Squad

Medical Device Biological Safety
The biocompatibility of medical devices is approached differently in the States than it is in Europe. FDA prefers a data-based approach. Europe prefers a literature-based defense. In either case, following the ISO 10993 or ISO 10993/G95 matrixes is only a beginning; the data supporting the biological safety of the final device must give ‘reasonable assurance’ of its safety in real use situations. You need to play ‘devil’s advocate’; thinking of all the ways your device might cause a biological reaction with the body and then address each possibility with data, proposed labeling, and a plan for mitigation.

For example, FDA raised the question if an implanted material might have a local oxidative effect. The question required the design of a unique animal test and a focused literature search reviewing the chemistry of the materials. In another example, FDA wanted to know the concentration of unreacted monomers, bimers, and trimers to the ppb level in a plastic, the analytical testing required a unique design. In a third example, reviewers wanted to know the possibility of an implanted material injuring a nerve, the solution required a sub-chronic test in which devices were implanted in dogs.

Clinical Device Group’s Rescue Squad

 

Your first contact with Clinical Device Group will be with Nancy J Stark, PhD. With a doctorate in biochemistry, Dr. Stark will assess your biological safety questions and determine if the firm is able to help you. She will answer your initial questions about the company, its history, services, and rates; will sign a confidentiality agreement and negotiate a service agreement with you. Once the administrative end of the relationship is in place, you’ll be referred to our primary toxicologist, Dr. Daniel McLain.

The Expert Himself

Next you’ll be referred to Dr. Daniel McLain, MS/PhD, Nutritional Toxicology and Preventive Medicine, who will begin immediately to assess your issues and recommend strategies and solutions. He may recommend a literature review, he may provide expert interpretations of laboratory reports, he may recommend additional testing at the test house of your choosing, he may assist in writing unique protocols for sub-chronic or chronic tests, or he may provide expert justifications of safety based on the data you have now. Dan can prepare risk assessments, preclinical strategies, or prepare the biological safety sections of 510(k)s, PMAs, or BLAs.

Dr. McLain is an internationally recognized toxicologist in the medical device industry and currently serves as the Convener for ISO 10993: Biological evaluation of medical devices – Part 11: Systemic toxicity evaluation. It is an extreme honor to serve as a convener, because it is a nomination of your peers, recognizing your expertise in the technical area and ability to work with people to bring them to consensus. He has had extensive interaction with global regulatory bodies as it pertains to product safety submissions and is held in high regard for his development strategies and commitment to product safety.

Now for Some Fun

First, click on the image to the right to solve the puzzle of biological safety.

Second, take Poll du jour 6, a 30-second quiz about FDA's views on biological safety and see how your answers compare to others.

Contact Us
Clinical Device Group Inc
773-489-5721
mailto: [email protected]