The High Cost and Complexity of Pharma Clinical Trials: A Cardiac Safety Perspective
- Elena Fraser
- Jun 24
- 4 min read
Pharmaceutical clinical trials are essential for bringing new therapies to market, yet they remain one of the most costly and complex aspects of drug development. On average, trials cost approximately $40,000 per day, with Phase III studies often exceeding $55,000 daily (Tufts CSDD, 2016). Across all phases, clinical trials for a single drug can surpass $300 million in total cost, with pivotal trials alone sometimes reaching over $100 million (Wouters et al., 2020). These figures reflect a broader challenge: drug development is increasingly expensive, time-consuming, and burdened by protocol complexity and regulatory requirements.
A major contributor to these rising costs is the extensive monitoring and site management required to ensure safety and data integrity. Monitoring and site oversight typically account for 25–30% of total trial expenses (Getz et al., 2015). For trials focusing on cardiovascular endpoints, the burden is even greater. These studies require frequent testing such as ECGs, imaging, and biomarker analysis, as well as continuous patient monitoring. Cardiac safety concerns are particularly consequential—up to 45% of drugs that are shelved or withdrawn from the market cite cardiotoxicity discovered during clinical trials as a primary cause (Laverty et al., 2011).
Adding to the financial strain are operational and equipment-related expenses. ECG machines alone may cost $100–$150 per month to rent, not including the costs of training, storage, and shipping (Kanefsky et al., 2018). Central labs help reduce variability in ECG interpretation, but they introduce their own set of logistics challenges and analysis fees. Additionally, recruiting and retaining participants—especially those meeting stringent cardiac trial criteria—is a time-consuming process that adds at least 30% to the duration and budget of most studies (Fogel, 2018). Regulatory requirements often push sponsors to over-monitor, despite updated guidance from the FDA encouraging risk-based approaches and central oversight (FDA, 2013).
Cardiac-focused trials face additional hurdles that elevate both cost and complexity. The frequency and volume of data required make cardiac safety studies uniquely resource-intensive. In the U.S., Phase II cardiovascular trials can exceed $7 million, with Phase III studies often ranging between $11 million and $53 million (Sertkaya et al., 2016). Each patient visit in such trials can cost anywhere from $3,600 to $5,500. On top of this, each ECG often requires interpretation by a cardiologist at a rate of $75–$250 per reading (Kanefsky et al., 2018). These expenses accumulate rapidly and are compounded by the risk of late-stage trial failures. If cardiac issues are not detected early, they can lead to Phase III terminations or post-market drug withdrawals, resulting in sunk costs and lost revenue opportunities.
The cumulative financial burden of clinical trials also takes a toll on innovation. According to the Tufts Center for the Study of Drug Development, delays in trials can result in sales losses approaching $500,000 per day, while daily operational costs hover around $40,000 (Tufts CSDD, 2016). Research costs have also been increasing at a rate of 7.4% per year, well outpacing inflation (Getz et al., 2015). In such an environment, the risk of investing in cardiovascular drug development—already among the most expensive therapeutic areas—is becoming increasingly unattractive to sponsors.
Innovative trial models are beginning to offer some relief. Centralized and risk-based monitoring strategies, now supported by both the FDA and EMA, have demonstrated cost savings by reducing unnecessary site visits and paperwork (FDA, 2013). Pragmatic trial designs using at-home testing and mobile cardiac telemetry have shown the potential to bring total trial costs below $2,000 per participant (Cohen et al., 2021). However, integrating these new tools into existing clinical infrastructure remains challenging due to issues such as regulatory alignment, training, and data security.
This is where DigiBeat can play a transformative role. Using cardiometric cardiography, DigiBeat offers a comprehensive cardiac monitoring system that directly addresses the inefficiencies plaguing current clinical trial models. Using cartometric cardiography and a secure cloud-based analytics platform, DigiBeat enables remote cardiac monitoring that supports both decentralized and hybrid trial designs. DigiBeats’s algorithms interpret multimodal data centrally, eliminating the need for expensive site-level equipment and manual data uploads. By supporting risk-based trial oversight, DigiBeat also helps trial sponsors minimize redundant site visits while highlighting patient measures that may indicate adverse reactions. The system is designed with user-friendly interfaces to improve participant compliance and retention, further reducing recruitment costs and trial delays. Most importantly, DigiBeat aligns with regulatory standards for cardiac safety and data integrity, making it easier for sponsors to meet FDA and EMA requirements.
DigiBeat transforms one of the most costly and complex components of clinical trials—cardiac safety monitoring—into a streamlined, cost-effective, and scalable process that accelerates drug development and ensures patient safety.
References
Cohen, J. D., Arora, V., & Prasad, V. (2021). Pragmatic trials: Bridging the gap between clinical research and clinical practice. JAMA, 325(20), 2041–2042. https://doi.org/10.1001/jama.2021.2179
Fogel, D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemporary Clinical Trials Communications, 11, 156–164. https://doi.org/10.1016/j.conctc.2018.08.001
Food and Drug Administration (FDA). (2013). Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. https://www.fda.gov/media/116754/download
Getz, K. A., Campo, R. A., & Kaitin, K. I. (2015). Variability in protocol design complexity by phase and therapeutic area. Drug Information Journal, 44(4), 421–430. https://doi.org/10.1177/009286151004400411
Kanefsky, R., Wakeman, D., & Watson, C. (2018). Cost evaluation of centralized versus on-site ECG interpretation in cardiac clinical trials. Journal of Clinical Studies, 10(2), 12–18.
Laverty, H., Benson, C., Cartwright, E. J., Cross, M. J., Garland, C., Hammond, T. G., ... & Valentin, J. P. (2011). How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines? British Journal of Pharmacology, 163(4), 675–693. https://doi.org/10.1111/j.1476-5381.2011.01255.x
Sertkaya, A., Wong, H. H., Jessup, A., & Beleche, T. (2016). Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials, 13(2), 117–126. https://doi.org/10.1177/1740774515625964
Tufts Center for the Study of Drug Development (Tufts CSDD). (2016). Outlook 2016. Boston, MA: Tufts University.
Wouters, O. J., McKee, M., & Luyten, J. (2020). Estimated research and development investment needed to bring a new medicine to market, 2009–2018. JAMA, 323(9), 844–853. https://doi.org/10.1001/jama.2020.1166
