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Bridging the Gaps in Study Conduct

by Dan McDonald

Today’s Challenges

There are some amazing things happening in the field of clinical research right now. The hottest topics at the conferences I’ve attended over the past 18 months have been those focused on disruptive innovations. All of the data points to trials becoming increasingly complex; from the number of procedures, to the geographic footprint, to the burden of proof required. We have all seen it.

The number of trials in rare and orphan indications, as well as oncology, including rare types of cancer – has exploded. These are challenging studies and innovative companies are emerging to help meet that demand. Big data, virtual trials, risk-based monitoring, the use of artificial intelligence, etc. — it’s all very exciting. It’s also a very small, arguably tiny fraction of all trials taking place. In most of the terrific stories you hear, such advancements don’t reflect critical mass. And, clinical operations teams often face big hurdles internally when introducing change. The future is bright, but the present is very challenging. Let’s talk about how Imperial is helping firms like yours address the most common and disruptive challenges.

Industry metrics communicate clear trends where there are still issues with various critical elements of study conduct. The time required to take new compounds from the bench to the bedside is taking longer than ever.

Reports on trends in study conduct activities across the industry have almost become predictable. Time and again, the survey findings that fuel these reports point to things like regulatory challenges, delays in contracting, delays in site initiation, delays in enrollment, attrition problems, and supply chain issues. The same culprits, again and again!

Our business development teams and operations teams here at Imperial are regularly meeting with clinical operations teams at sponsors and CROs across North America and Europe. Without a doubt, the issues we hear that clinical teams are challenged by the most include:

  • Delayed site initiation and first patient in
  • Not meeting enrollment timelines and targets
  • Losing ground with compliance and attrition issues
  • Struggling with the complexities of increasingly global trials      

Patient Engagement

Think about the function of patient recruitment and retention — what we refer to today as patient engagement. It’s a critical function of study conduct support and one where many organizations have struggled. During the late 1990s and throughout the 2000s, patient recruitment agencies arose and came to prominence. The topic of proactive patient recruitment was a novel one, and these agencies led the charge in educating the drug development industry about the importance of such an approach. They carved out a unique service category niche and they thrived.

Eventually — and essentially — the industry embraced the need for proactive recruitment and retention strategies to occur as early in the study planning process as possible. The concept is not novel anymore. Sponsor study teams develop their own strategies and determine what approaches they want to find, enroll, and keep patients in studies.

Today, this gap in the market is fulfilled by service providers who understand and can deliver the select set of services that sponsors want to meet a particular need. A study brand. A study website. Recruitment materials. Written, translated, formatted, designed, printed or digitally produced in one place. It’s one of the gaps we are helping to bridge here at Imperial. We plug in and often act as the backroom engine behind these bright study teams and the strategic approach they have chosen for driving enrollment.

There are similar stories for the issues of on-time study startup, site initiation visits, and first patient in. Stories of dealing with the complexities of global trials, such as challenges with supply chain, language, and logistics, etc. — those are stories for another time.

If you’d like to hear more and discuss how Imperial is bridging these critical gaps in study conduct, please come speak with us at the 2019 DIA Annual Meeting. You can find us at Booth 1812 (AND you could win a gorgeous Coach Ava tote!). We look forward to seeing you!

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