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Clinical guidelines are taking hold in the practice of medicine. Though not always voluntarily followed in real-world patient care, they increasingly form the basis of formulary and reimbursement decisions, as well as the continuing medical education (CME) materials used by physicians.

In this guidelines-centric culture, it is more imperative than ever for drugs to be on the guidelines, and also harder than ever to influence the data that determines them.

Best practices around clinical guideline development call for independent analysis of raw data – untainted by financial gain or academic prestige.

In this tightly controlled and highly sensitive environment, what can Pharma do to maximise the credibility and visibility of its products?






Report Overview



The Path to Product Inclusion in Clinical Guidelines: Strategies for Success

If you’ve looked for information about clinical guidelines written with Pharma in mind, you’ve probably ended your search empty-handed.

The sensitive nature of the Pharma-clinical guideline relationship has made it difficult for Pharma to talk about this important topic.

This FirstWord Dossier report addresses this critical knowledge gap, and has been designed to get Pharma up to speed with the complexities of clinical guideline development and adherence, and to be prepared for future trends. The report also provides practical insights on how to increase visibility of medicines, even in an area that is beyond commercial influence.

In spite of most companies’ reluctance to speak on this subject, FirstWord has sourced illuminating commentary from Big Pharma representatives and prominent clinical guidelines experts.

Don’t miss this ground-breaking report – available now.






Learn about

Exclusive insights from industry experts
Clear documentation of how Pharma’s footprint is being eliminated from the appraisal of evidence
Explanation of the critical importance of clinical guidelines in rationalising the use of medicine
Cautionary tales of challenges to the guidelines
Detailed description of the latest standardised methods and best practices for research and guideline development worldwide (e.g., CONSORT, PRISMA, AGREE)
Up-to-date findings on adherence to guidelines
Handy global list of websites for referencing clinical guidelines







Key Benefits

Understand and effectively respond to the profound cultural shift towards evidence-based healthcare
Know how to gain a tactical advantage by considering a product’s place in clinical guidelines before development starts
Receive expert advice on how to position data and products for better visibility
Get up to speed with the new concept of “activation of evidence”
Hear how the full and open disclosure of clinical trial results is likely to become the norm rather than the exception
Learn how clinical guidelines are moving from demonstrating best practice to best value


Key Questions Answered

What can Pharma do to make best use of the evidence they have?
What do opinion leaders want from Pharma?
What are the major trends in guideline development, and how can we ensure that our scientific messaging is in line with that thinking?
Why don’t doctors always follow the guidelines?
How holy is the holy grail of evidence-based medicine?


Who Should Read This Report

Professionals with responsibilities for:

Brand Management
Marketing
Medical Education
Pharma Publications
Medical Affairs
Clinical Trials




Expert Views Include:


Charlie Buckwell, director of McCann Complete Medical
Dr Tobias Gantner, founder and CEO of The Healthcare Futurists and a market access professional in Germany
Adam Jacobs, director of the UK consultancy Dianthus Medical
Dr Philip Mackowiak, chief of the Medical Care Clinical Centre of the VA Maryland Health Care System
Jim Smeeding, president of the TPG National Payor Roundtable
Dr Allen Sniderman, Cardiologist, McGill University Health Centre, Montreal, Canada
Dr David Williams, senior pharmaceutical physician
Senior Executive, top 20 pharma


Key Quotes

“The perspective of people who know how to manage data and the pitfalls would be valuable on [guideline] committees and I think they would also mitigate the influences where there are conflicts of interest,” Dr. Philip Mackowiak, chief of the Medical Care Clinical Centre, VA Maryland Health Care System

“[The PPSA’s policy on KOL payments] suggests that anybody who works with a pharmaceutical company is somehow doing something wrong. We are not going to move forward. We are not going to advance medical science.” Dr. Maurie Markman, senior vice president of clinical affairs, Cancer Treatment Centres of America

“The only way forward is to look at the very early phase development work, which is about defining the clinical need around which you need to design your future products.” Charlie Buckwell, chief executive, McCann Complete Medical




Table Of Contents

The Path to Product Inclusion in Clinical Guidelines: Strategies for Success
1.Executive summary
2.Rise of evidence-based healthcare
2.1. Publications practices rise to the fore
2.2. Open and complete reporting of clinical trial results
2.3. Consolidating standards
2.4. Facilitating comparison

3.Clinical guidelines: the cornerstone of EBM
3.1. Authority to withstand influence
3.2. Guideline explosion
3.3. A cautionary tale
3.4. Pitfalls of potential bias

4.Cataloguing the guidelines
4.1. Systematic guideline review
4.2. Guidelines International Network
4.3. Improving guideline quality
4.4. Well trodden paths at UK's NICE
4.5. Guideline development in the US
4.6. Setting new standards
4.7. Systematic reviews in guideline development
4.8. Clinical practice guidelines we can trust
4.9. Flaunting of IOM standards
4.10. Deciding the deciders
4.11. Conflicts of interest

5.Working with the guidelines
5.1. Relationship-building
5.2. Effect of the Sunshine Act
5.3. New ways of working with physicians
5.4. New ways of working with payers
5.5. Publication strategy
5.6. Creating credible evidence


6.The clinical care gap
6.1. Implementation of guidelines
6.2. Labour intensity of guidelines
6.3. Multi-morbidity
6.4. Activation of evidence
6.5. Guidelines inform policy
6.6. Rationalisation of treatment
6.7. Treatment pathways
6.8. Fierce data battles
6.9. Medical malpractice

7.Acknowledgements
7.1.Appendix: National and international clinical guideline websites

View This Report »

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