Source: https://www.linkedin.com/pulse/evaluation-clinical-trial-costs-barriers-drug-luca-dezzani-md/ The complete analysis of the costs and barriers to drug development in 2018. All the expenses to conduct clinical trials and the split by disease areas Clinical trials are a crucial part of the drug development process. Pharmaceutical companies conduct clinical trials to demonstrate safety and efficacy in order to gain approval from regulatory bodies. In recent times, the cost of clinical trials has increased and the time it takes to bring a drug to market is becoming longer. In 2003, the estimated cost of bringing a drug to market was US$802 million. The cost is no longer the same. In 2016, The Tuft Center for the Study of Drug Development estimated the cost of the same process at $2.6 billion. The escalating cost of conducting clinical trials discourages pharmaceutical companies from traveling this path of drug development and consequently limits patients’ access to novel treatments. Many companies are looking for possible ways to cut down the cost of clinical trials and avoid barriers to drug development in order to improve drug development process. The cost of clinical trials varies amongst therapeutic areas and even from phase to phase. In phase 1 studies, Immunomodulation has the highest costs (US$6.6 million) and endocrine and pain and anesthesia incur the lowest clinical trial costs (US$1.4million). In Phase 2, hematology trial costs ($19.6 million) are the highest while cardiovascular clinical trials rank the lowest (US$7.0million). Pain and anesthesia therapeutic area have the most costly Phase 3 studies and dermatology has the lowest cost (US$11.5million). In Phase 4, respiratory system trial costs ($72.9 million) rank first while genitourinary system has the lowest cost (US$6.8million). Overall, respiratory system clinical trials are the most expensive with a total cost of US$115.3 million. Pain and anesthesia and oncology therapeutic areas are also expensive costing US$105.4 million and US$78.6 million respectively per clinical study. What goes into the cost of a clinical trial? The table below provides a breakdown of the cost components of clinical trials conducted in the US. Excluding site overhead costs and other unclassified costs, the most costly components of clinical trials include: Administrative staff costs ($7.2 million), Clinical procedure costs ($5.9 million), Site monitoring costs ($4.5million) and Site retention costs ($4.5 million). Looking at the subtotal costs per phase, it is quite evident how the costs of clinical trials increase as drug development progresses from Phase 1 to Phase 4. Cost Drivers In the last decade, medical researchers have been evaluating more cost effective ways of conducting clinical trials and to fast-track clinical translation of new treatments. However, proving clinical effectiveness of new treatment -in a world of diverse potential patients- is becoming increasingly complex. Many companies are then faced with the task of recruiting even more patients at multicenter sites. This automatically translates to increased costs of clinical trial. As seen in the previous sections, the therapeutic area is also a major cost driver. The clinical trials for drugs focused on certain therapeutic areas can be long, complex and expensive. “Other cost drivers include increasingly complex clinical trial protocol development, greater emphasis on data and site monitoring, increased use of technologies and the delays caused by differing interpretations of compliance regulations (such as patient consent forms) by the many parties involved in multicenter trials” (Collier, 2009). Barriers to Clinical trials The major associated with conducting clinical trials in the United States include: High costs of clinical trials Lengthy timelines Difficulties in recruitment of participants Insufficiencies in the clinical research workforce Strict regulations and administrative barriers Data collection and interpretation inefficiencies Complexity in maintaining and monitoring safety References ASPE. (2018). Examination of Clinical Trial Costs and Barriers for Drug Development. [online] Available at: https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development [Accessed 8 Aug. 2018]. Collier, R. (2009). Rapidly rising clinical trial costs worry researchers. Canadian Medical Association Journal, 180(3), pp.277-278. Sertkaya, A., Wong, H., Jessup, A. and Beleche, T. (2016). Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials, 13(2), pp.117-126. Tufts CSDD. (2014). TUFTS CSDD R&D COST STUDY Press Release March 2016. [online] Available at: https://csdd.tufts.edu/s/pr-coststudy.pdf [Accessed 8 Aug. 2018]. Luca Dezzani is a Novartis employee. All the views, analysis, and perspectives are fully independent and belongs to the author only. They do not represent the views or opinions of Novartis or any other company or organization. IgeaHub is a pharmaceutical blog created and curated by Luca Dezzani. IgeaHub does not receive any funding or support from Novartis or any other pharmaceutical company.