Electronic Patient Diaries: Driving Clinical R&D and Post-Launch Marketing Efforts

SUMMARY

INTRODUCTION

This Brief assesses the value of electronic patient diaries relative to theirpaper counterparts in clinical trials and post-marketing. An overview of thecurrent patient diary market, as well as the industry's best practices, isprovided. Several vendors within the space are evaluated based on theirofferings and business approaches.

SCOPE OF THIS REPORT

• Primary interviews with executives from key vendors in the electronicpatient diary market
• Communication with FDA in regards to electronic diaries and their papercounterpart
• Coverage: US, Europe, Asia-Pacific

REPORT HIGHLIGHTS

Datamonitor estimates that patient diaries, both paper- and electronic-based,are currently used in 25 to 30 percent of clinical trials.

A recent study sponsored by the National Cancer Institute found low levels ofpatient compliance with paper diaries and a greater level of compliance withelectronic diaries.

Datamonitor forecasts that 25 percent of patient diaries used in clinicaltrials will be electronic-based by 2007.

KEY REASONS TO BUY THIS REPORT

• Evaluate the benefits electronic patients diaries can offer over theirpaper counterparts
• Understand the current status of the patient diary market and how it willevolve
• Determine whether investment in electronic patient diaries should bepursued

TABLE OF CONTENTS

 Introduction

 Scope Report

 Highlights

 Reasons to Purchase

Drivers and trends

Patient diaries are an important component of a significant proportion ofclinical trials. Datamonitor estimates that 25 to 30 percent of all clinicaltrials currently use diaries, whether paper or electronic, to collect patientself-report data. At the moment, the proportion of patient diaries that use theelectronic format is approximately three percent. This proportion is likely togrow as electronic patient diary technology transitions past its pilot period.As pharmaceutical companies finalize their strategies to implement electronicpatient diaries, the transition from paper to electronic-based patient diarieswill occur more readily. This shift is likely to occur given the advantages thatthe electronic format provides over paper.

The brief analyzes the future growth potential of the electronic patientdiary market and answers what the industry' s best practices are:

• What benefits do electronic patient diaries offer over their papercounterparts?
• How can electronic patient diaries be used in the collection ofself-report data during the clinical trial process and in regulatorysurveillance?
• What is the current size of the patient diary market and the penetrationof electronic diaries?
• Which format of electronic patient diaries, in terms of hardware andsoftware, is ideal for a given clinical trial?
• Who are the main players in the current electronic diary space and howwill the vendor market evolve?

CHALLENGING THE PARADIGM OF PAPER

• Electronic patient diaries fully or partially resolve many problemsassociated with their paper counterparts. They can potentially providebetter data quality, faster time to data lock and improved subjectcompliance. These advantages of electronic diaries allow for improvedefficiency in collecting and processing patient self-report data, which canreduce the length of the clinical development process. Reducing the time tomarket helps to maximize revenues from a prospective product.
• A recent study sponsored by the National Cancer Institute (NCI) confirmedthe problem of patient non-compliance with paper-based diaries and theprospective advantages of the electronic form
• A representative from the Center for Drug Evaluation and Research, thedivision of the FDA responsible for evaluating new drugs, reported toDatamonitor that, for certain trials, electronic diaries can potentiallyprovide more accurate data than their paper counterpart
• Datamonitor predicts that 25 percent of patient diaries used in clinicaltrials will be electronic-based by 2007

THE FUTURE VENDOR MARKETPLACE

• As the pharmaceutical industry scales up its electronic diary use, thevendors offering scalability and end-to-end clinical development solutions,either organically or through partnerships, will survive the marketshakeout. In deciding which vendor to employ, companies should considerwhich hardware and operating platform is most applicable to their clinicaltrials and the depth of information to be collected. Future productpipelines and advances in supporting infrastructure should also beconsidered, particularly when choosing a vendor for a technology license.
• There are currently four principal types of electronic patient diariesbased on the type of hardware used: mobile phones, handheld devices, tabletPCs and desktop computers
• The vendor market may be segmented based on hardware, business model andwhether or not they are pure-play electronic patient dairy providers
• The current trend of partnerships and mergers and acquisitions activitywith electronic data capture vendors is likely to continue within theelectronic patient diary space, potentially creating end-to-end clinicaldevelopment solutions

ACTION POINTS

Three key action points for pharmaceutical companies

• Action point 1 – As the advantages of electronic patient diariesover their paper counterparts are increasingly recognized, the market forsuch devices will expand over the next five years
• Action point 2 – In selecting a vendor to provide electronic patientdiaries, pharmaceutical companies should consider the appropriateness of thehardware and operating platform to the given clinical trial
• Action point 3 – The current trend of partnerships and mergers andacquisitions activity with electronic data capture vendors will likelycontinue within the electronic patient diary market, offering the prospectof end-to-end clinical development solutions

DATASETS

• Figure 1: Electronic patient diaries have the potential to resolve many ofthe problems associated with paper-based diaries
• Figure 2: Datamonitor forecasts that the proportion of patient diariesthat are electronic-based will increase as their use moves out of the pilotphase
• Figure 3: The appropriate form of electronic patient diary is dependent onthe complexity of the self-report data and frequency with which it must becollected