Talking about technology

Rachael King, CEO, CRF Health

Q. Partnerships between CROs and research sponsors are increasingly punctuating the clinical trial industry. How important are partnerships between CROs and their technology providers?
Very. It is important that CROs have full confidence and trust in their technology partners. A good technology partner will help strengthen the reputation of the CRO with the sponsor. Building and nurturing a strategic partnership requires work on both sides to make sure that customers understand the proposition, and after a buying decision, receive the value they are expecting. From the sponsor’s perspective, the technology provider should appear to be a truly integrated component of the CRO offering. This must include full data integration so that the CRO and sponsor can make data driven decisions without ‘cutting and pasting’ from multiple reports. In addition, the efficiencies for tight integration of technology solutions can help CROs deliver more cost effective and efficient trials to their clients.

Q. Monitoring patients in their own home is thought to be the answer to growing clinical trial costs. How can ePRO ensure that at-home patients comply, and supply the most accurate data to the study investigators?

Electronic patient reported outcome (ePRO) systems can ensure compliance to clinical trial schedules in ways that are impossible with paper solutions. CRF Health has developed some unique methods to encourage data collection with a reward system. This can be combined with text message and email alerts and gentle reprimands when observations are missed. Integration with other medical devices, such as spirometers, can reduce the burden on the subject and also ensure different data types are closely linked and visible together. In addition, a level of competition can be encouraged by sharing compliance data between individuals and site and study staff. Finally, making data visible in intelligent ways that highlight areas of concern or lack of compliance can also facilitate oversight by medical personnel.

Patients have become more interested in participating in their treatment, and that is an opportunity as well as a threat to pharmaceutical companies. Patients’ expectations for a clinical study have increased. Satisfaction with a study is driven by factors like patientphysician interaction, but also on how well the study is catering to the patients’ desire for learning more about their condition and treatment options, and how respected they feel. Patients want to be considered partners in research, rather than objects of study procedures. The other side of the coin is that patients are less satisfied if they are not actively engaged in the study. Dissatisfaction means lower compliance and higher drop-out rates. Therefore, the supporting and the engaging of patients becomes increasingly important.

Q. Describe how CRF Health is working with the regulators to ensure its products are able to get as close to the patient as possible?
CRF Health has recently registered as a medical device manufacturer. Our registration covers medical device databases and medication reminders. In addition, CRF Health is one of the founding members of the ePRO consortium helping to promote best practices in PRO collection. The ePRO consortium is formed under the auspices of C-Path and driven by the US FDA.

Q. Is CRF Health planning to launch any new products in the next 12 months? How will these bring innovation to the clinical research community?
CRF Health is launching a number of new offerings in 2012. The first is in January, when we will announce TrialMax Web™, our late-phase offering. We will also be launching TrialMax® 5.0 with many new features including intelligent reporting and subject engagement and retention tools. New user interfaces for all devices will also be launched. All of CRF Health’s new products will enable the pharmaceutical companies to engage patients and sites into more active study participation.

Q. What challenges do you see for the technology provider space in 2012, how do you plan to overcome these next year?
With growing interest in outcome data within the pharmaceutical industry and the pressure from regulators to collect efficacy data directly from subjects, the environment is very positive for technology providers. The pressure is to provide high quality, cost effective solutions that fully integrate with other eClinical systems. CRF Health has seen growing uptake in the use of TrialMax Synapse™ to integrate data in real time to both EDC and back-end systems. In 2012 we foresee this growing further and possibly integrating into safety systems.

The challenges and the rewards in eClinical, and especially in patient technologies, is balancing between the cutting edge technology and simplicity, reliability, and robustness required in global clinical studies. Our approach is to work with the community, including patients and sites, to optimise our product offering.