Are Clinical Trials Costly in 2023?

Yes, clinical trials are very costly in 2023. With the increasing number of clinical trials worldwide, the costs of conducting these trials are also increasing. As more research is conducted and new treatments are developed, the demand for clinical trials has risen. 

Over the years, various articles and market research reports have mentioned contradicting prices for clinical trials and globally bringing new drugs to the market. According to a report by the National Institute of Health (NIH), “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018”, the average cost of developing a new drug lies between $314 million to $2.8 billion. On the other hand, in a report by the Pharmaceutical Research and Manufacturers of America” titled  “Biopharmaceutical Research & Development: The Path to New Medicines”, the average cost to research and develop each successful drug is estimated to be $2.6 billion. 

What are The Most Expensive Therapeutic Areas?

According to an ASPE report titled “Examination of Clinical Trial Costs and Barriers for Drug Development”, the respiratory system represents the therapeutic area that demands the most significant clinical research efforts across all stages, with a financial commitment of $115.3 million. Subsequently, pain and anesthesia trials require $105.4 million, and oncology trials necessitate $78.6 million in expenses.

Besides the per-study costs by therapeutic area of medication, according to a Statista report – “Projected top therapy areas worldwide in 2027, by spending(in billion U.S. dollars)”, it is estimated that in 2027 the global spending on this therapeutic area will reach $377 billion. The anticipated expenditure for Immunology is expected to rank second, amounting to approximately $177 billion.

Strategies to Reduce Clinical Trial Costs: 

Reducing the cost of clinical trials is a challenge. Still, there are a number of ways to make trials more cost-effective without sacrificing the quality or integrity of the research.

• Using lower-cost facilities: Reducing clinical trial costs involves embracing lower-cost facilities like community clinics and regional medical centers and leveraging in-home testing to eliminate frequent site visits. Decentralized clinical trials (DCTs) utilize virtual and remote technologies, allowing participants to stay home, cutting expenses tied to site infrastructure and staff. Virtual visits, telemedicine, and wearable devices can further reduce costs while ensuring data collection and monitoring efficiency. These measures can improve cost-effectiveness without compromising trial quality or participant safety. According to the ASPE report, utilizing low-cost facilities can reduce per-trial costs by up to 16% in Phase 1, 22% in Phase 2, and 17% in Phase 3, depending on the therapeutic area.
• Patient recruitment and retention strategies: By retaining patients, the need for costly and time-consuming recruitment of replacements diminishes. Additionally, enhanced data quality from long-term participation leads to more accurate results, reducing potential expenses incurred from data cleaning and corrections. High patient retention rates increase the chances of trial success, saving resources and funds invested in unsuccessful trials. Furthermore, utilizing remote monitoring technologies minimizes travel costs, making participation more accessible for patients and reducing expenses associated with site visits.
• Partnering with CROs: Partnering with Contract Research Organizations (CROs) decreases clinical trial costs by leveraging their expertise and efficiency, shared resources, and targeted patient recruitment. CROs’ streamlined data management, regulatory compliance, and negotiation power with vendors also contribute to cost savings. CROs like NoyMed, identify and mitigate risks, facilitate global trials, and propose adaptive trial designs for efficiency. Quality control measures ensure data accuracy, reducing errors. Faster time-to-market accelerates revenue generation. During a recent study, NoyMed’s SAS programmers conducted data analysis and review within 2 weeks after the database lock, saving 4 weeks compared to the average industry time. Sponsors must choose reputable CROs and maintain effective communication.
• Optimized protocol design: This can significantly cut clinical trial costs by reducing sample size, streamlining data collection, and shortening trial duration. It improves patient recruitment and retention, minimizes the need for protocol amendments, and enhances resource allocation. Adaptive designs allow real-time adjustments, potentially reducing expenses. Patient-centric approaches improve compliance and engagement. Clear decision-making criteria prevent the unnecessary continuation of unproductive trials. Well-designed protocols ensure regulatory compliance, avoiding costly delays or penalties. Careful protocol development ultimately leads to substantial cost savings while maintaining trial quality and integrity.
• Using advanced technology: Technologies like electronic data capture (EDC), wearable devices, telemedicine, and artificial intelligence (AI) for data analysis reduce manual efforts, minimize data errors, and accelerate trial timelines. Virtual and decentralized trial approaches leverage remote monitoring and digital platforms, reducing site-related expenses. Trends include blockchain for secure data management, machine learning for patient recruitment, and AI-driven predictive analytics for optimized trial design. 

Summary:

In conclusion, clinical trials remain costly in 2023 due to increasing demand for research and new treatments. However, several strategies can help cut costs without compromising trial quality. Utilizing lower-cost facilities and in-home testing, implementing patient recruitment and retention strategies, partnering with CROs, optimizing protocol design, and leveraging advanced technologies contribute to enhanced cost-effectiveness. By adopting these approaches, researchers and sponsors can work towards making clinical trials more efficient, frugal, and ultimately beneficial for patients and the healthcare industry.