The Evolution of Patient-Centered Clinical Trials

Getting the science right in clinical trials is just the beginning. With R&D costs jumping 15% to $2.3 billion per drug¹, pharmaceutical companies are discovering that scientific excellence alone isn't enough to guarantee success. Even more concerning, the return on investment for new drugs has plunged to the lowest percentage recorded in 13 years of tracking.¹

Why Patient Engagement Matters Now More Than Ever 

The statistics paint a clear picture of an industry at a crossroads. While total R&D spending by pharmaceutical companies reached approximately $245 billion in 2023², the returns on these massive investments remain uncertain. Everyone wins when trials align with patient needs and capabilities: researchers get better data, sponsors see faster completion rates, and patients receive better care throughout the trial journey.

The Hidden Costs of Poor Patient Engagement 

Extended Trial Timelines

Each protocol amendment (a formal change in trial protocol after the trial has begun) costs approximately $200,000 and adds 2-3 months to development time.³ Making matters worse, protocol design complexity has increased by 44% over the past decade,³ creating more opportunities for costly adjustments when patient needs aren't properly understood.

Recruitment Challenges

Studies show that approximately 19-30% of clinical trials fail due to patient recruitment difficulties⁴, so traditional recruitment methods are clearly failing. The shift toward precision medicine and targeted therapies makes patient recruitment even more challenging, requiring a deeper understanding of patient decision-making processes and practical barriers to participation.

Data Quality Issues

Regulatory authorities now emphasize that patient perspectives provide valuable insights on treatment benefits and risks.⁵ When trials fail to capture these insights adequately, a cascade of complications results, from protocol amendments to regulatory delays.

The Power of Specialized Patient Research  

Pharmaceutical and Biotech companies that partner with specialized research firms have found undiscovered insights that traditional methods easily miss, resulting in significant improvements in recruitment timelines and patient retention rates that exceed industry averages. This is where firms like MDRG are changing the game. Research shows that patient engagement can significantly reduce protocol amendments, which typically cost between $150,000 and $500,000 each⁶ —demonstrating why specialized research expertise is essential in the complex clinical trial landscape.

Looking Ahead with MDRG 

In Part 2 of our series, The Smart Company's Guide to Patient-Centered Clinical Trials, we'll reveal how leading pharmaceutical companies are using real-time patient feedback to transform their ongoing trials and share innovative methodologies that separate industry leaders from the competition. 

Want to get ahead of the curve? Contact us today to learn how our specialized research expertise can help you build stronger, more patient-centered clinical trials.

References 

1. "The Unbearable Cost of Drug Development: Deloitte Report Shows 15% Jump in R&D to $2.3 Billion." February 28, 2023. https://www.genengnews.com/topics/drug-discovery/the-unbearable-cost-of-drug-development-deloitte-report-shows-15-jump-in-rd-to-2-3-billion/

2. "Global Trends in R&D: Overview through 2023." April 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2024-activity-productivity-and-enablers 

3. "Impact Report: Rising Protocol Design Complexity Is Driving Rapid Growth in Clinical Trial Data Volume." January/February 2023. https://f.hubspotusercontent10.net/hubfs/9468915/TuftsCSDD_June2021/pdf/Rising+Protocol+Design+Complexity+is+Driving+Rapid+Growth+in+Clinical+Trial+Data

4. "Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review." 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/