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Better, Faster, Stronger

EPC: What is the biggest challenge in your role at the moment?

Jim Carroll: Solving the ongoing challenges around patient enrolment timelines, which represent a significant rate-limiter in bringing new treatments to market. While clinical trials usually proceed through a linear series of steps, our customers are demanding novel strategies that support shorter timelines through parallel processing of critical path activities. Our business is focused on helping customers speed up the patient enrolment timeline in a predictable manner.

Which part of your role is the most rewarding?

When our customers realise that the unique set of capabilities we provide will help solve the greatest challenges in meeting, and even exceeding, patient enrolment timelines for their trials. Ultimately though, it is all about helping customers accelerate research progress, and putting new treatments into the hands of patients who need them the most.

What do you think the clinical trials sector needs to focus on at the moment?

Innovation. The industry is taking steps in the right direction, but too often sponsors rely on yesterday’s approaches to address the greater complexity of today’s trials. For a long time, biopharma companies have been making the wrong assumptions – on how long it takes to enrol a trial, how many sites are needed in which countries, and how many patients per site.

The biggest mistake is assuming that investigators themselves will produce the patients; this has proven to be wrong. For example, it is known that nearly 50% of sites are unable to meet their enrolment objectives, yet under-performing investigator sites are still being selected for trial participation. Today, novel data, analytics and modelling capabilities can all be utilised to better understand which investigators to choose, and the implications the chosen group will have on overall patient enrolment timelines.

What should pharma be doing to accelerate recruitment and reduce study timelines?

Get ahead of the problem. First, select those sites that have a demonstrable track record of success. At the same time, take a proactive, patient-centric approach in order to understand expected barriers that patients might face, and create a comprehensive recruitment strategy to mitigate them prior to the study start. Protocols today are unique in their level of complexity, and this warrants a unique assessment and an extensive plan that can deliver the right results faster.

How are new mobile technologies and social networking methods improving patient retention and engagement?

Today, mobile technologies and social networking represent primary channels for patients seeking information and engaging with others around their condition. Historically, patient recruitment was about finding patients and motivating them to take steps towards participating in a trial. Often, mass media were used, but served as a rather blunt instrument in attracting the right patients.

Through mobile and social channels, finding the right patients and motivating them to pursue participation happens significantly faster. Using these platforms to communicate with patients about study-related information is extremely effective from an overall engagement perspective, while supporting both recruitment and retention needs.

What motivates you?

Seeing our customers accelerate patients’ access to life-saving treatments. There is a tremendous amount of resources and determination that goes into bringing new treatments to market. Helping to accelerate this is something that is easy to be passionate about.

How do you think the pharma industry as a whole will change over the next 10 years?

There will be greater emphasis on developing treatments for rare conditions and special populations with unmet medical needs. We can also expect continued focus on building infrastructure to support emerging markets where there are sizable populations with limited access to care. Treatments are readily available for many of the large chronic disease categories but, in many cases, additional, population-specific research is needed. Creating access to these treatments globally must be increased.

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Jim Carroll, Vice President Product Management and Marketing for iCTRS, brings more than 20 years of healthcare, data analytics, technology and product marketing experience to his role at inVentiv Health. He is a founding member of iCTRS and has oversight responsibility for all aspects of the company.
Jim Carroll
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