The complexity and high costs associated with clinical trials make efficiency a top priority. With patient recruitment challenges, site management issues, and the need for high-quality data, many trials face schedule delays and budget overages.
According to the Tufts Center for the Study of Drug Development, the average clinical trial delay can cost sponsors $600,000 to $8 million each day a drug is not on the market. Failing to implement solutions for these challenges risks missing key development timelines, jeopardizing investments, and undermining stakeholder confidence.
Here are five key ways that sponsors and CROs can mitigate risk and optimize clinical trial performance:
Patient recruitment and retention are critical pain points in clinical trials, contributing to an estimated 85% of all clinical trials experiencing delays. Over 30% of sites under-enroll patients, and 11% fail to enroll a single participant. Each day lost in recruitment can equate to millions in lost revenue and increased costs.
By bringing ophthalmic assessments directly to patients, you can remove common participation barriers such as transportation issues and the need to take time off work. The convenience offered by point-of-need clinics helps sponsors and CROs expand their patient pool, accelerate recruitment, and improve retention rates. A robust patient population not only drives the study’s success but also avoids costly trial extensions or amendments that can disrupt the drug development timeline.
Ensuring high-quality data and regulatory compliance is paramount in ophthalmic clinical trials. Inconsistent or suboptimal data can result in costly protocol deviations, data cleaning, and even study redesigns—adding weeks or months to the timeline.
Utilizing vendors with certified, highly skilled ophthalmic professionals who follow Good Clinical Practice (GCP) guidelines and stringent SOPs ensures that the data collected is consistent, reliable, and adheres to protocol requirements. For sponsors and CROs, this means minimizing the risk of variability and non-compliance, leading to a smoother regulatory review process and faster time to market.
Unforeseen delays are a significant challenge in clinical trials, with over 50% of sites reporting that trials often exceed their projected timelines. These delays can disrupt life-changing drug development pipelines and increase costs. Flexibility and scalability are crucial to overcoming these obstacles.
By utilizing highly adaptable solutions that can scale up or down depending on unique study needs can help avoid this risk. Whether it is expanding the number of mobile clinics deployed to cover a larger geographical area or adjusting visit schedules based on patient availability, your vendor needs to tailor its services to mitigate the risk of delays. This adaptability helps sponsors and CROs keep trials running on schedule and within budget, avoiding the pitfalls associated with rigid site-based models.
Achieving diverse and inclusive patient populations is a key focus for the clinical research industry. However, traditional site-based models often fail to recruit a representative patient pool, with logistical barriers disproportionately affecting underrepresented groups. Failure to meet diversity targets risks regulatory scrutiny and compromises the scientific validity of study outcomes.
Sourcing vendors that have a track record of bringing eye assessments directly to diverse communities helps sponsors and CROs overcome these barriers. By expanding access to underserved and underrepresented communities, sponsors and CROs can achieve the diversity and inclusion goals essential for regulatory approval and study success.
The WCG 2024 Clinical Research Site Challenges Report found that 77% of sites identify reducing administrative burden as a top priority. Excessive workload and logistical complexities at traditional sites can lead to increased staff turnover and reduced site performance, ultimately delaying clinical trials.
One solution is point-of-need assessments. Sourcing a partner that can conduct comprehensive eye assessments wherever is the most convenient for patients, such as their homes, is paramount. This service reduces the strain on site staff, streamlines scheduling, and eliminates the need for patients to make additional trips to busy investigative sites. For sponsors and CROs, this translates into reduced site burnout, improved staff retention, and more consistent study operations—factors that directly contribute to keeping trials on schedule and within budget.
Selecting the right vendors is critical for sponsors and CROs aiming to protect the value of their clinical research investments. 20/20 Onsite’s innovative point-of-need delivery models provide a strategic advantage in clinical trial management.
By providing clinical trial solutions that minimize trial delays, reduce costs, and ensure data integrity, 20/20 Onsite is redefining clinical trial management by bringing ophthalmic assessments directly to patients through a unique fleet of point-of-need delivery models. By eliminating the need for traditional site visits, 20/20 Onsite reduces site burden, enhances patient access, and delivers high-quality data—all critical factors in preventing delays and maximizing return on investment (ROI).
For more information on how 20/20 Onsite can support your next clinical trial, schedule a consultation.