The Path to Product Inclusion in Clinical Guidelines: Strategies for Success
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?
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
“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
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?
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
- 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
- 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?
“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
EXECUTIVE SUMMARY
RISE OF EVIDENCE-BASED HEALTHCARE
Publications practices rise to the fore
Open and complete reporting of clinical trial results
Consolidating standards
Facilitating comparison
CLINICAL GUIDELINES: THE CORNERSTONE OF EBM
Authority to withstand influence
Guideline explosion
A cautionary tale
Pitfalls of potential bias
CATALOGUING THE GUIDELINES
Systematic guideline review
Guidelines International Network
Improving guideline quality
Well trodden paths at UK’s NICE
Guideline development in the US
Setting new standards
Systematic reviews in guideline development
Clinical practice guidelines we can trust
Flaunting of IOM standards
Deciding the deciders
Conflicts of interest
WORKING WITH THE GUIDELINES
Relationship-building
Effect of the Sunshine Act
New ways of working with physicians
New ways of working with payers
Publication strategy
Creating credible evidence
... that payers want
THE CLINICAL CARE GAP
Implementation of guidelines
Labour intensity of guidelines
Multi-morbidity
Activation of evidence
Guidelines inform policy
Rationalisation of treatment
Treatment pathways
Fierce data battles
Medical malpractice
ACKNOWLEDGEMENTS
Appendix: National and international clinical guideline websites
RISE OF EVIDENCE-BASED HEALTHCARE
Publications practices rise to the fore
Open and complete reporting of clinical trial results
Consolidating standards
Facilitating comparison
CLINICAL GUIDELINES: THE CORNERSTONE OF EBM
Authority to withstand influence
Guideline explosion
A cautionary tale
Pitfalls of potential bias
CATALOGUING THE GUIDELINES
Systematic guideline review
Guidelines International Network
Improving guideline quality
Well trodden paths at UK’s NICE
Guideline development in the US
Setting new standards
Systematic reviews in guideline development
Clinical practice guidelines we can trust
Flaunting of IOM standards
Deciding the deciders
Conflicts of interest
WORKING WITH THE GUIDELINES
Relationship-building
Effect of the Sunshine Act
New ways of working with physicians
New ways of working with payers
Publication strategy
Creating credible evidence
... that payers want
THE CLINICAL CARE GAP
Implementation of guidelines
Labour intensity of guidelines
Multi-morbidity
Activation of evidence
Guidelines inform policy
Rationalisation of treatment
Treatment pathways
Fierce data battles
Medical malpractice
ACKNOWLEDGEMENTS
Appendix: National and international clinical guideline websites
