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Phase IV studies: Pioneering approaches are re-engineering processes, timelines and costs

Phase IV is in a state of flux. New digital methods are on trial, there’s an explosion of data sources, and more questions about the level of evidence needed are being asked. At the same time, drug companies are trying to control costs. What’s the best way forward?

If you want to design and carry out more effective Phase IV trials studies, you need to find out what lessons have already been learned about lean protocol design, opportunities for savings and considering the patient voice, from companies like Genentech and Sanofi (see the full list). You'll also get fresh insights into how key studies have performed, and clear pointers to what could be improved.

Top Takeaways

Separate standard operating procedures are needed for Phase IV studies
Planning should start earlier for Phase IV studies to improve their effectiveness and business value
Research objectives need to be clear and focussed to avoid waste of resources
New protocols and platforms are beginning to impact on study design, data collection and methodologies
Potential for significant savings exists but these won't be realised until confidence in the methodologies improves
Including the patient's voice is easier – but there are still careful considerations required
Key real-world drug-use learnings can result from new approaches

Key Issues Explored

When should you start considering Phase IV studies in your testing processes?
How patient insights and various customer needs can result in benefits for all stakeholders
Insight into ground-breaking trials and lessons learned so far in 2 key case studies including the Salford Lung Study
The new integrated evidence pathways gaining ground and what their true long-term value is likely to be
The growth and use of databases by researchers
How new partnerships forged by drug companies to progress studies are working in practice
Concerns around quality and reliability of evidence gathered

Who needs this report?

Anyone involved in designing, recruiting, executing or analysing Phase IV studies – to see how they can be improved
Regulatory teams – to gain insights into current and new practices
Executives who want to understand evolution of best practice and explore potential cost savings
Data managers at pharma companies, CROs and associated organisations
Manufacturers and programmers of wearable medical and health devices (such as FitBit) – to understand potential future applications
Patient engagement teams – to understand new ways of involving patients

Who needs this report

Professionals charged with hiring, training, managing or evaluating MSLs and intent on fully leveraging their potential.
Executives who wish to optimise the utility of the MSL function in their organisations.
Managers looking for insights on the future of the MSL role in pharma.
MSLs who want to continue to excel in the field in the years to come.


Charlie Barr, Group Medical Director and Head, Evidence Science and Innovation, Genentech
Dr Nadir Ammour, eClinical Director, Sanofi
Chris Liebman, Vice President, HEOR, Global Market Access, Biogen Idec
Dr Shontelle Dodson, Head of Medical Affairs Excellence, Astellas US
Dr David Leather, Medical Affairs Leader in the Respiratory Franchise, GlaxoSmithKline
Dr Tobias Gantner, Director Health Economics & Market Access, Janssen Germany
Jeff Trotter, co-founder and managing director, Continuum Clinical
Mike Minor, Senior Vice President & Global Head Operations and Strategic Planning, Peri-Approval & Observational Research, ICON
Lynn Okamoto, Executive Vice-President for Late Stage research, InVentiv Health
Kai Langel, Director of patient solutions, e-clinicalhealth

About FirstWord

FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.

FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.

Table Of Contents

Harnessing the Power of Phase IV Observational Studies
1. Executive Summary
2. Research Objectives and Methodology
3. Setting the scene
3.1.Challenging healthcare inflation
3.2.Commercial implications
4. What is Phase IV?
4.1.Multiple research methods
4.2.What do Phase IV studies seek to do?
4.3.Integrated evidence collection pathways
4.4.Market access considerations
4.5.Phase II/IV studies
4.6.Multiplicity of questions
5. Key trends in retrospective data collection
5.1,Data quality rising
5.2.Infrastructures building at different rates
5.3.Database limitations
5.4.Acquiring data
6. Key trends in prospective data collection
6.1.Interventional studies
6.1.1.Case Study: Salford Lung Study
6.2.Prospective observational studies
6.3.Broadening the population
6.4.Patient registries
6.4.1.Case Study: TRUMPET registry
6.5.Disease registries rising
6.6.Cost versus benefits
7.Introducing mobile technology
7.1.Mobile healthcare tracking
7.2.Early days
7.3.Confidence building
7.4.Physician/patient recruitment
7.4.1.Case study: ADAPTABLE trial
7.5.Remote trials
7.5.1.Case study: Pfizer's REMOTE trial
7.5.2.Case Study: VERKKO trial
8. Operational challenges in Phase IV
8.1. Core questions
8.2. Lean protocol design
8.3. The registry option
8.4. Research ecosystem
8.5. Conservatism
8.6. The evidence science
8.7. Are standards too high?
10. Outsourcing trends
10. Embracing the patient voice
10.1.Patient preference analysis
10.2.Empowered patients
10.3.Patients help study design
10.4.Patient-reported outcomes
11. Future trends

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