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European Pharmaceutical Contractor

Dial-a-Trial

Mark Taggart and Patrick Hughes at Exco InTouch look at the evolution of ePRO technology in clinical trials

The introduction of electronic patient reported outcomes (ePRO) tools has helped to revolutionise the clinical trials industry by facilitating data collection and improving the quality of patient reported data. Traditional paper-based methods of collecting patient data are gradually being replaced by new electronic technology, including handheld devices, interactive voice recognition (IVR) and internet eDiaries.

Sponsors and CROs understand that mobile phones have become as important as car keys and wallets to everyday life. Companies are now using this dependence to streamline the collection of patient data in clinical trials.

This article will provide an overview of traditional and existing methods of patient data collection and will discuss emerging solutions that can help to improve and streamline the clinical trials process.

PATIENT DATA COLLECTION IN CLINICAL TRIALS

Traditionally, patient data in clinical trials has been collected by the use of paper diaries completed by the patient with details of the medication’s effects. Paper diaries are simple to complete and individual templates for specific therapy areas can be easily developed. However, data quality is a common issue as many trial participants simply forget to complete the diary at the necessary time, resulting in inaccurate or incomplete information. In addition, paper diaries are easily mislaid by patients or clinic staff, resulting in incomplete files. These factors can have a detrimental impact on the outcome of the trial and highlight the need for sponsors and CROs to develop alternative methods that are capable of improving patient data collection.

To overcome some of the limitations of paper diaries, handheld electronic devices have been adopted by many sponsors and CROs for ePRO collection. These devices, typically containing a simple electronic diary, are based on PDAs and have become synonymous with ePRO solutions over the last few years. The rise in use of this type of device was born primarily out of the challenges experienced when using paper diaries and the struggle to maintain patient compliance for ePRO collection.

Handheld devices are typically installed with an electronic diary application specific to the study being carried out. The patient accesses this application and inputs diary data directly into the device as required by the study guidelines. When using handheld diary devices, date stamps can be implemented on each entry to ensure that the data has been collected and recorded at the appropriate time. Data recorded on these handheld diary devices can also be easily transferred without the risk of transcription errors which often occur when using traditional paperbased diaries.

Despite the advantages of handheld ePRO devices, a number of logistic and operational issues can arise which present challenges to clinical trials sponsors and CROs. The cost and time it takes to deliver these devices, combined with other logistical hassles, have made adoption slow, except for in critical path studies where the primary or secondary end points require PRO.

In the current economic climate, sponsors and CROs are looking for ways to streamline the clinical trials process at the same time as minimising expenditure. While handheld devices offer a more reliable means of data collection compared to traditional paper diaries, there are substantial cost implications. For example, an average Phase III clinical trial requires between 300 and 3,000 patients, depending upon the medical condition studied. As sponsors need to provide an ePRO device to each patient, this can add significant expense to the trial.

As well as the cost of purchasing and configuring these ePRO devices, shipping to clinic sites adds further expense. As an average 40-foot shipping container can only transport approximately 400 PDA devices, a trial with 1,000 or more patients would incur considerable transport and import/export costs, particularly where trials are coordinated in emerging markets such as Brazil, China and India. These logistical challenges are furthered by the issue of storage at the investigator sites. Many sites also double as clinics or doctor surgeries, which means that storing several hundred ePRO devices can be impractical.

The ease of use of ePRO devices is another key consideration for sponsors and CROs. Using traditional paper diaries is straightforward and does not require indepth training for the user. However, depending on the type of ePRO device used, significant training can be required for both patients and site staff. The ease of use of a device to record patient diaries in clinical trials can have a significant effect on patient compliance. For example, if a patient finds the device difficult to use, they will be less inclined to input data regularly and may even cease completing the diary. Similarly, if staff at the investigator sites are not fully trained to record and analyse the patient data, transcription inaccuracies can occur.

EMERGING ePRO TOOLS

The use of ePRO solutions such as handheld devices has highlighted the capability of these tools to overcome many of the limitations of traditional paper-based diaries. However, the challenges associated with handheld devices are leading sponsors to seek alternative ePRO technologies.

New technology, such as interactive voice response (IVR) systems, has been successfully implemented to optimise the collection of clinically valid and sensitive data directly from participating patients. IVR automates interactions with telephone callers through a set of predefined questions and allows a computer to detect patient responses through voice and telephone keypad inputs. IVR assessments offer several advantages over traditional paper diaries. Questions are standardised, asked and scored through automated methods and patients can access IVR assessments via telephone at investigator sites or from their own home.

Like most ePRO methods, IVR has some limitations. The systems are not designed to support complex questions or lengthy patient responses. The use of IVR also presents a challenge to patients based in countries lacking a robust telephone infrastructure. Patient non-compliance can also be an issue as IVR requires the patient to take the first step in dialling into the system. As with paper diaries and handheld devices, site staff are often required to send out reminder letters or make phone calls to patients to prompt them to complete the IVR assessment.

As an alternative to handheld diary devices and IVR systems, many large pharmaceutical sponsors are implementing mobile phone technology to collect patient data. Mobile phone technology is a flexible ePRO tool that can be used in a number of different ways depending on the study requirements. As the technology is implemented via the patient’s own mobile phone, devices do not have to be shipped to the sites, which can help to minimise costs. With an estimated 3.5 billion mobile phone users worldwide, these devices are familiar and easy to use, removing the need for patient and site staff training.

In a typical application, mobile phone-based ePRO technology can be customised to suit the requirements of the trial. Where specific and targeted data collection is required, patients can complete diary questionnaires via a series of text messages sent to their own mobile phone. If a response is not received by the patient within a certain timeframe, a text message reminder can be sent automatically in order to prompt a response. The ability to capture patient data in ‘real time’ means that investigator site staff can be alerted to abnormal patient data and react to ensure patient safety. This approach is typically used for health outcome programmes or those requiring frequent and simple data collection.

Where more complex patient data is required, mobile internetbased eDiaries can be deployed. Patients receive a text message which contains a link to a secure mobile website containing the eDiary. The patient then connects to the eDiary site via mobile internet and enters a unique PIN number to access an ePRO questionnaire. This type of technology enables a wide range of questions to be presented and viewed on any mobile phone. Online eDiaries also allow for more complex questionnaires and lengthier patient responses. In addition, questionnaires can be customised to improve ease-of-use for the patient by including widgets such as radio buttons and check boxes. Real-time reporting can be easily built into the system, which enables the sponsor to view eDiary responses as they are submitted and respond quickly to any issues.

For clinical trials requiring extremely complex or extensive patient data collection, downloadable mobile phone applications containing eDiaries are now available. These applications are simple to set up and can be easily tailored to a particular area of study. Using this tool, patients are automatically sent a link which allows them to download a diary application directly to their mobile phone. The application runs on the mobile phone and only connects to the internet when transmitting ePRO data to study sites. Unlike many ePRO solutions, mobile phone-based eDiary applications can handle complex data calculations based on patient responses, and are capable of displaying visual prompts to make completion simple for the patient. Some eDiary applications are also capable of using validated scales specific to therapy areas, for example the Western Ontario and McMaster Osteoarthritis (WOMAC®) scale.

Recent studies have shown that mobile phone-based eDiaries can increase patient compliance rates by up to 95 per cent, as well as reduce overall clinical development costs. The issue of patient non-compliance can also be overcome by configuring mobile phone technology to send automated text message reminders directly to the patient’s mobile phone. Reminder messages can be tailored to the individual and can include information such as dosage, frequency and advice on taking the medication safely.

The challenge with adoption of a new ePRO solution approach, such as using the mobile phone, is that study teams well remember the challenges of early ePRO and devices without secure digital cards, and may be apprehensive of re-learning how to undertake ePRO. Mobile phone operating systems have been developed by network operators to cope with data transmission as well as downloading and playing material such as ringtones, music and games, so devices are easily configured for use within an ePRO environment.

With the help of data sending and the surge in text message usage, the mobile phone industry is soon expected to exceed sales of $1 trillion and network providers are continuously developing devices that will make mobile phone technology even more essential to daily life. These factors mean that mobile phone technology is becoming an effective device for the collection of ePRO data.

REGULATORY CHALLENGES

The pharmaceutical industry is strictly regulated and all methods of data collection and evaluation must meet the industry’s stringent guidelines in order to be suitable for use in clinical research. It is important that all electronic methods of patient communication are developed in accordance with the regulatory requirements of FDA 21 CFR 11 as well as the US Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Directive 2002/58/EC on privacy and electronic communication.

CONCLUSION

Methods for collecting patient reported outcomes during clinical trials have evolved significantly over the years, with new technology being introduced to reduce costs and improve the quality of patient data. Using emerging technology such as mobile phone-based methods for ePRO collection can help to lower the overall costs of a trial and ensure high-quality patient data. The familiarity and ease of use of mobile phone devices helps to improve patient compliance rates, while patient reporting via mobile phone technology has also been demonstrated to improve data integrity.

As ePRO technology evolves, no single modality for the collection of patient reported outcomes will fulfil the complex requirements of sponsors and CROs. However, in the future, different combinations of emerging technology will enable sponsors and CROs to obtain a complete picture of the effects of specific drugs on a patient population.


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Patrick Hughes joined Exco InTouch as an Executive Director in 2007. Previously, Patrick worked for the clinical technology organisation ClinPhone plc in various senior management roles including sales and marketing, product management and strategic business development. These roles focused on the commercial management and strategic direction of IVR, ePRO, EDC, patient recruitment and CTMS technologies.

Mark Taggart joined Exco InTouch in April 2009 as Sales Director. Mark has been involved in the ePRO industry since 2000. Prior to joining Exco InTouch, he was at CRF Box (CRF Health) and then etrials, helping many pharmaceutical clients adopt the wider use of ePRO. Mark is involved with the development of Exco InTouch’s patented technology and simplified approach to ePRO, which solves many of the traditional burdens.

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