Why Inject Additional Risks into Clinical Trials?

Christine Tobin |

With clinical development costs and timelines continuing to escalate— averaging $2 billion and eight years to bring a drug to market¹— and regulatory standards becoming more strict with greater emphasis on trial oversight and the need  for more complex study designs to demonstrate safety and efficacy, the stakes are higher than ever for today’s pharmaceutical developers.

All this means more data, more data sources, and more systems in an environment where budgets and people are ever more strained.

Against this backdrop, clinical trial performance metrics continue to be underwhelming.  Less than 10 percent of trials end on time and nearly half of all sites under-enroll study volunteers.¹

So, at a time when trial sponsors are continually seeking ways to improve efficiencies in the clinical development process, it’s mind-boggling that some are still using outdated, and in many cases, manual approaches to collect, aggregate, and report clinical trial data when automated, centralized solutions streamline operations, improve study efficiencies and yield better results.

Uncertainties, risks and complexities result in poor clinical trial performancePaper Diaries Just Don’t Make the Cut for Clinical Trial Data Capture

Electronic Clinical Outcome Assessment (eCOA) data capture has been around for decades, its benefits widely published. It’s mind-boggling that nearly half of all studies that collect patient outcome data do so using primarily paper solutions.

Paper methods are not reliable, as they offer no controls over data entry timeliness or quality. Data from patients using paper COA are often incomplete (skipped items), illegible (poor handwriting) and illogical (inappropriate responses).

Further, patients using paper COA routinely fail to comply with study protocols regarding scheduled data entry times and end up completing diaries in batches just prior to a site visit (termed ‘parking lot compliance’syndrome’). Patients also forward-fill paper diaries; research showed that 45 percent of patients in a pain study invented data by forward filling at least once.²

eCOA overcomes all of these challenges, delivers higher quality data and improves study efficiencies. Through built-in reminders, eCOA significantly improves patient protocol compliance (as high as 97%, compared to 30% with paper²). And, its inherent ability to date/time-stamp entries eliminates doubts regarding the timeliness of data collected.

By eliminating out-of-range and incomplete responses and capturing data in real time, sponsors using eCOA eliminate the need for study teams to spend countless hours reviewing paper diary data and seeking follow-up information to confirm data accuracy before database entry, which accelerates time to study close-out.

Don’t Leave Imaging in the Dark Ages

Regulatory agencies are increasingly asking sponsors to include quantitative image analysis for the evaluation of clinical trial data. However, variability across images collected (and subsequent analyses) leads to a need for larger sample sizes, longer timelines and bigger budgets. This means imaging data must adhere to quality standards — not only to meet regulatory expectations, but also to ensure trial outcomes success.

Yet, some sponsors are sticking to traditional approaches to image collection, evaluation and management that cause compliance and data quality issues and often result in lost images, as well as subjective / variable data. But proven technology-driven solutions help sponsors overcome these challenges and bring myriad benefits to clinical studies, including accuracy, consistency, adaptability and compliance — all of which drive efficiencies and enable sponsors to make decisions about endpoints sooner.

Technology-driven imaging solutions deliver myriad benefits in clinical trials
Conclusion

While many sponsors and CROs still rely on outdated, often paper-based data collection and management approaches, the pressure to improve trial efficiencies will bring about changes in how they approach these critical aspects of clinical development.  

In order to keep up with evolving trends – a more competitive marketplace, stricter regulatory standards and the need for more complex study designs to demonstrate safety and efficacy –- trial leaders will need to rethink their current approaches in order to accelerate research and lower development costs.  Only then will they remain competitive and be positioned for success.

Download ‘Minimizing Risk and Uncertainty in Clinical Research’ for 10 tech-driven, easily implemented approaches that give trial leaders confidence in meeting their clinical development goals and help them achieve higher quality data, lower costs and shorter study timelines.

1. “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance,” ISR, 2015.
2. “Patient Non-compliance with Paper Diaries,” British Medical Journal, Stone, A., 2002.

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