In the past year, clinical trials received a great deal of attention as the COVID-19 story unfolded from panic to prevention. As COVID-19 vaccines and other treatments were being tested at an unprecedented pace, discussions around clinical trial phases, efficacies, and adverse events took center stage.
For COVID-19 as well as other clinical trials, it is important to put things into perspective as we enter a new era of designing, operating, and concluding clinical trials through digital and hybrid versions.
Clinical trials are associated with inherent trust issues in the minds of participants due to nonstandard dosing, lack of historical safety data, logistic challenges, and oftentimes an apparent lack of support. For the trial sponsors, traditional recruitment channels have been inefficient, relying overtly on offline networks and over-indexing on expensive offline media.
This article employs a quantitative, cost-based approach to evaluate the benefits of running clinical trials digitally. If you are a trial sponsor or site, read on to break down the trial costs and appreciate the tangible dollar impact that digital avenues can have on your trial operations. If you are a patient or a healthy person and interested in knowing the behind-the-scenes process of a clinical trial, this article will help you gain some perspective so that you can make the right choice, if and when you consider participating in a clinical trial and contributing toward improving healthcare for all.
The cost of running a clinical trial significantly varies according to the therapeutic area, ranging, for example, from eye drops and skin creams to infusions of multiple oncology drugs. It is further determined by prevalence, complexity of the condition, ease of recruiting participants, and ease of identifying or maintaining trial sites. A cross-sectional study found that the median cost of a clinical trial engaging 495 patients on an average was $48 million.
Table 1. Cost of Trial Per Drug by Therapeutic Area
Source: National Centre for Biotechnology Information (NCBI). doi: 10.1136/bmjopen-2020-038863
Two major factors impact costs of clinical trials:
1. Total number of participants: This constitutes a significant component of the total cost. The median cost per patient enrolled is $41,117 on an average and the overall cost proportionately increases with the increase in the number of trial participants
2. Total number of clinical visits: From screening to baseline randomization, treatment, and benefit assessment, the number of participant visits required can range from 2 to 200 per trial. Each patient visit to the study clinic costs an estimated median of $3,685
Table 2. Major Elements Driving Cost As Percentage of Overall Trial Cost
Source: Examination of Clinical Trial Costs and Barriers for Drug Development. https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development.
Phase 1: In the first phase of a clinical trial, individuals without underlying conditions are tested with drugs to find out the highest possible dose without serious side effects. This phase goes on for several months. The cost incurred in this phase is usually a small fraction of the overall trial cost
Phase 2: The second phase can last from a couple of months to years and establishes the drug efficacy. The participants are usually already diagnosed with the condition. They can vary in number from double digits to a few hundred
Phase 3: The third Phase is the most elaborate phase, in which multiple participants pool in to establish the safety and efficacy of the drug in comparison with the existing medications for the same condition. With the highest number of participant enrollments and clinical visits, phase 3 trials are usually the most cost-intensive
Phase 3 can last for several years before approval and incurs an average of $28 million as trial cost for drugs approved in a single trial, $45 million for 2 trials, and $91 million for drugs that require 3+ trials before the regulatory approval. For combination or adjuvant therapy, more trials are needed to get approvals for closely related indications.
The digital wave has unlocked new avenues for clinical trials. A 2017 industry study found that majority of sponsors outsource more than 60% of their trial budget, and an increasingly large portion of that work requires digital platforms or communication channels. Digitalization of clinical trials is a trend that is propelled by COVID-19 and likely to continue as regulatory agencies across the world continue to encourage virtual solutions.
For the most effective clinical trials, sponsors need to build onstage capabilities for processes that directly impact patients such as recruitment and engagement, as well as behind-the-scenes capabilities that are not patient centric but impact their trial experience.
Approximately, 6,000 clinical trials were halted last year during the peak period of the pandemic. They have now been resumed but in digital-only or hybrid avatars.
Every radical challenge brings an opportunity for transformative solutions. Here lies the opportunity to streamline clinical trial operations and reduce overheads by adopting a digital-first approach. However, with digital progress comes the need for a user-friendly interface, privacy, trust, and protection of data. If we consciously address these aspects, we’re good to go.
If the last century saw the bulk of evidence-based healthcare as we know it today, this one will be known for experience-based care. The post-pandemic patient takes inspiration from sustainability, diversity, inclusion, and equity. Digital technologies give healthcare researchers a direct line to initiate trials based on the participants’ vitals, emotions, and experiences.
It is time we leverage that responsibly.
To learn perspectives from pharma leaders like Edward Jordan, Craig Lipset, Sudip Sinha, and Francesca Properzi with terrific real-world experience of implementing digitalized clinical trials, I would highly suggest checking out this on-demand webinar.