Reducing Clinical Trial Costs: 7 Effective Methods

The U.S. clinical trials market, valued at 22.6 billion in 2021, is expected to grow by a CAGR of 5.4% from now to 2030.¹ Growth within the research and development sector is needed to continue improving and advancing care capabilities; however, of the many logistical hindrances that can impact these studies, high costs remain a key limitation — $161 million to $2 billion is the average estimated cost of getting a new drug through testing to market.² Out of the studies that make it to the pivotal third phase of trials — considered the most extensive and expensive of the three phases³ — an estimated 22% cannot continue due to costs.⁴

Reducing clinical trial costs not only benefits current developing endeavors but also frees up funds for future studies. Here are seven innovative ways to reduce clinical trial costs:

1. Design studies for efficiency 

Opportunities to reduce costs begin at the planning stage when it is possible to implement a more efficient trial design. Minimizing the total number of required subjects while still meeting all regulatory and data collection requirements, for example, reduces total spending on participants and assists with the chronic issue of patient recruitment.⁵

Going so far as to implement an adaptive clinical trial design can increase trial efficiency and flexibility and may also require fewer participants.⁶ The FDA defines an adaptive design as "a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial."⁷ This design approach allows for trial modifications that reduce unnecessary resources and total trial time while optimizing patient participation and study relevancy.⁸ The many potential applications, benefits and limitations of the adaptive clinical trial design are still being explored by researchers.

2. Streamline processes

Streamlining individual processes within clinical trials can add up to significant reductions in time and cost. Identifying essential endpoints and working through the necessary methods to reach them can highlight wasted resources and reduce the number of extraneous procedures. Gathering feedback from those closely involved with the processes, such as trial staff or participants, may help identify further bottlenecks, unnecessary data collection and other overlooked improvement areas. 

Working with regulatory authorities will ensure the trials maintain feasibility, all protocols are followed, and potential issues are identified. Adherence to good clinical practice (GCP) guidelines will also help reduce protocol amendments and other delays. According to a study by Tufts, around 57% of protocols are amended, with each amendment during the third phase costing an average of $535,000.⁹ The same study found that 45% of those amendments are somewhat avoidable.¹⁰

Strategic supply chain management is another area to optimize resource usage by limiting drug or device storage, distribution and disposal costs. The cost of storage, for example, may be reduced by centralizing storage or shared facilities with industry partners like contract research organizations (CROs) and academic institutions.

3. Incorporate technology

New technology has broadened the data collection opportunities. Wearable devices have made participant data collection more widely available during day-to-day behaviors. This wearable technology also comes in many forms, such as watches, rings, cuffs and clothing sensors, which have an array of monitoring capabilities like heart rate, blood pressure, skin temperature, breathing rate, oxygen saturation and electrodermal activity.¹¹ In addition to wearables, other advancements like at-home testing and telemedicine have limited the need for on-site lab testing and consultations. The remote collection of patient health data through these devices and telehealth connections can make participation more convenient while reducing the costs associated with site management, monitoring and patient travel. For example, imaware's tests, which can include a custom biomarker panel, are easy for patients to complete from home before shipping to a certified lab for analysis. 

These remote capabilities have also made it possible for decentralized clinical trials. Decentralized clinical trials (DCTs) are when all trial procedures are conducted so patients have little to no contact with a physical trial site.¹² While decentralized clinical trials are still under high scrutiny and may not be feasible for specific studies, hybrid designs, which allow for the remote collection of less complex data, are being adapted with increasing frequency.¹³

4. Implement data management tools

In addition to patient monitoring, technology advancements have increased data management capabilities. Collecting real-world data, like electronic health records, claim databases and other registries, can supplement portions of trial research and even produce data for areas such as historical control groups or observational studies.¹⁴

When it comes to data analysis, many existing and emerging technologies can help optimize the process, such as automation and A.I. tools that process large datasets and generate statistical analysis. A good Electronic Data Capture (EDC) system can significantly reduce timelines and costs by streamlining data collection, checking data quality, and following proper data reporting guidelines.¹⁵ This kind of system also makes it easier to share essential findings with key stakeholders. 

5. Maximize patient recruitment

Recruitment accounts for approximately 30% of development timelines,¹⁶ and according to a report on trials from 2015 to 2016, each recruited patient costs around $6,533.¹⁷ While recruitment may be time-consuming and expensive, it is also critical to clinical trials, as a lack of trial participation can result in costly delays and, in many cases, the inability to ever advance beyond the first testing phase. 

Effective recruitment starts with initial outreach, such as leveraging patient registries and other existing databases to have better success at reaching the target audiences. Targeting established groups can also assist with locating individuals enthusiastic about participating, increasing their likelihood of engaging with the clinical trial and remaining active for the duration. 

Devices like at-home tests and telemedicine support can make clinical trial participation a much simpler and more appealing prospect. Not only that, but a big draw of hybrid and decentralized clinical trials is the expanded audience, as they decrease the location-based barriers to participation. According to McKinsey & Company, 70% of potential participants live over two hours away from a trial site.¹⁸ Additionally, a Harris Interactive Survey from the U.K. found that 21% of eligible patients who declined participation cited necessary travel distance.¹⁹ Making participation as easy as possible and expanding the audience range will do wonders for the recruitment process.

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6. Don’t forget retention efforts

Recruitment is only part of the strategy, as approximately 30% of patients drop out before clinical trials are complete.²⁰ Since the costs associated with replacing participants are even higher than initial recruitment costs, retention efforts are a high-priority area for cost reduction. Steps taken during the recruitment process, such as careful pre-screening criteria or options other than complete withdrawal, can assist in maintaining higher retention rates. Another popular strategy is providing monetary participation incentives, like gift cards. Better patient engagement through thank-you notes, appointment reminders, educational newsletters, support resources, and more can also boost participation rates.²¹

Reducing the burden on patients can improve participant satisfaction and, thus, retention. Implementing more efficient data collection and management systems like those mentioned in previous sections can reduce spending on unnecessary analysis and lessens the amount of information patients must take the time to provide. And like recruitment, having flexible testing options, such as at-home testing, makes it easier for participants to stay on even if there are changes to their circumstances.   

7. Seek collaboration/partnerships

Collaborating with CROs and other industry partners can be essential for the success of clinical trials. There are many benefits from this kind of connection, including shared resources, infrastructure and expertise. CROs, for example, can be selected to fit specific needs, from full-service to specialized in a particular trial phase or medical condition. CROs are also able to provide a variety of cost-saving solutions, like utilizing existing patient recruitment networks.²²

Community partnerships and patient advocacy group connections help reduce costs, as they provide valuable input for everything from study design and critical endpoint identification to participant diversity and increased retention.²³ Working with these groups to improve recruitment diversity is essential as, unfortunately, participation is often disproportionate to the actual population. By improving audience education, these partnerships also tackle another key barrier to participation, misinformation and dear.

Final thoughts

Being able to reduce clinical trial costs can be the determining factor as to whether or not a clinical trial is able to progress through all the required phases. However, while emerging cost-reduction strategies are undoubtedly important to these endeavors, ensuring they do not compromise patient safety and data integrity is crucial.

Are you considering incorporating hybrid decentralized strategies into your clinical trials? Connect with imaware today to discuss the possibilities for custom at-home testing.

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