Clinical trials play a vital role in the development of new therapies and treatments for various medical conditions. However, a significant barrier to conducting clinical trials is their high cost, driven primarily by the time and resources required to activate them and reach participant accrual targets.
The R&D costs associated with bringing a new drug to market are estimated to range between $314 million and $4.46 billion1, depending on the therapeutic area, and clinical trials are the biggest contributor to this. In fact, global spending on clinical trials is set to reach $68.9 billion a year in 20252, so any strategies to reduce costs while maintaining study integrity are of huge interest to the industry.
So how can the joint challenges of high costs and delays be minimized within clinical trials? This is the fourth of a series of articles exploring how to navigate some of the key challenges faced by clinical data professionals and how Viedoc can help.
Factors influencing clinical trial costs and delays
Clinical trial costs can vary significantly depending on a range of factors:
Patient recruitment and retention
This accounts for up to 32% of overall trial costs, and it can also cause up to 80% of trial delays3. Recent data suggests that 18% of enrolled patients drop out, leading to 85% of all clinical trials failing to recruit enough patients4.
Complexity of the trial design and protocol
Trials that involve multiple study sites, complex treatment regimens, or specialized equipment can be more expensive to conduct. The therapeutic area being studied can also impact costs. Certain areas, such as oncology or rare diseases, can require additional expertise, specialized tests, and higher patient recruitment efforts, resulting in higher expenses.
Regulatory requirements and compliance
Ensuring adherence to ethical standards and regulatory guidelines requires additional resources and expertise. The complexity of the regulatory landscape can also contribute to longer approval times, further increasing costs.
Geographical location
Conducting trials in certain regions or countries may involve higher operational expenses, such as transportation and logistics. Factors like local regulations, infrastructure, and availability of qualified personnel can also impact costs.
Inclusion of patient-centric elements
Implementing approaches such as patient engagement programs, or patient travel support, may require additional investments but can also enhance patient experience and improve trial outcomes.
So, what’s the answer?
In order to target high costs and delays within clinical trials, three key areas to look at are leveraging technology solutions that automate and streamline various trial activities, addressing patient recruitment and retention, and ensuring regulatory compliance:
1. Leveraging technology solutions that automate and streamline
Electronic data capture (EDC) systems have revolutionized the way clinical trials are conducted. Data is captured and analyzed in real-time, eliminating the need for time-consuming and error-prone manual data entry. This not only saves time but also reduces the risk of data inaccuracies, ensuring the integrity of trial results.
At Viedoc, we pride ourselves on our streamlined and fast study setup. Getting a new study up and running in the EDC requires minimal previous experience in database design or programming. Thanks to one unified platform, your clinical team won’t need to worry about transferring data to different systems or training on several platforms. And with a faster workflow, you can minimize costs and avoid delays.
2. Addressing patient recruitment and retention
Enabling decentralized or hybrid trial (DCT) solutions and a more patient-centric approach to the study protocol design would have a big impact here. This patient-centric approach also reduces costs and takes some pressure off the on-site staff. This opens up the possibility for patients and sites to work together globally, regardless of where they’re located.
Where standard COAs (clinical outcome assessments) are very manual and labor intensive, an eCOA (electronic-clinical outcome assessment), through Viedoc Me, can directly capture the trial data on a patient's smart device, making it easier for patients to get through the trial and boosting your trial retention.
3. Ensuring regulatory compliance
At Viedoc, we have an in-house Quality Assurance (QA) department with experts in the field. The team is on hand to answer any questions and help keep you aligned with the latest FDA and EMA regulations, making sure you are compliant at all times.
Viedoc offers cost-effective solutions for small to medium-sized studies, providing speed and compliance without sacrificing complexity through a secure, cloud-based platform.
The best way to gain a clear picture of how Viedoc can help streamline your clinical trials is to explore why our EDC is consistently voted number one on G2.
Reference
1. https://pmc.ncbi.nlm.nih.gov/articles/PMC11214120
2. https://www.nature.com/articles/d41591-019-00008-7
3. https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_Intelligent-clinical-trials.pdf
4. https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591
