Amendments and complexities can compromise budgets

Drug development is an expensive and time-consuming process. On average, it costs $319.3 million for initial research and development and can take over eight years before a drug reaches the market. Additionally, 86.2% of all trials fail to reach market approval.

‍‍On top of the burgeoning costs to design and run a trial, over 50% of all clinical trials have at least one protocol amendment. This can be disruptive to study sites and create major logistical challenges, even requiring the re-consent of patients if the delivery method or data capture is changed.

According to researchers, implementing planned and unplanned mid-study changes can delay a trial by 30 days. In one study, the average cost of trial delays was found to be over $500,000 for Phase III trials and increased the duration of the trial by as much as three months. With many studies averaging more than two amendments, this time can soon blow your budget.

Over the past five years, clinical trials have also grown increasingly complex. Companies are targeting more complicated and rare disease states with narrowly defined patient populations, decision makers want to see more patient-reported outcomes, and biomarker data has become a new benchmark for many diseases, increasing the cost and complexity of data collection. In 2015, an average of 187 procedures were done in Phase III trials, a 70% increase from previous years.

This increasing complexity in design also affects the study sites that carry out the trial enrollment and data collection.

Additionally, it can be hard to keep enrollment numbers high when there are unplanned changes to a trial as participants may become concerned by the changing protocols.
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Adaptive clinical trials are challenging old assumptions

To overcome the barriers associated with unplanned changes, some clinical trials are switching to a more flexible, adaptive trial approach. According to the Food and Drug Administration, an adaptive trial is “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.” One example is a design with adaptive dose selection, in which the aim of the study is to research the dose-response relationship.

In a 2019 guidance document, the FDA recommended adaptive trial approaches because they increase the likelihood of patients receiving a beneficial treatment. One analysis found that this more accommodating approach can increase the likelihood of a drug’s approval by 13%, rising to 32% for some therapeutic areas such as oncology.

Overall, adaptive trials are more efficient, take less time to complete, and need fewer participants. By allowing for pre-planned modifications to a trial’s design after it has begun — modifications that are based on real-time data accumulated from the trial’s participants — adaptive trials make much better use of resources and money. By design, interim data checks and analysis can help investigators make pre-specified mid-trial changes while maintaining the validity of the trial, something that is not always possible with the more traditional clinical trial approach.

“This real-time data evaluation maximizes the information available from the data collected to shorten development timelines through faster go/no-go decisions and reduce overall costs,” says Dr. Mert Aral, Chief Medical Officer at Huma. "It is also important to note that adaptive trials can also be safer for participants since mid-study checks can identify important safety signals and allow for modifications to study protocols. This maximizes the probability of success with regulators and payers, while, at the same time, reducing costs and commitment time.”

In order to design a successful adaptive trial, experienced investigators are required to ensure that the design does not compromise the integrity of the data. For example, the European Medical Association’s guidance points out that too many interim data checks may invalidate the study results. They recommend that interim analyses should only be performed when absolutely necessary and potentials for bias should be explored before the start of the trial. Many stakeholders and decision-makers are not as familiar with an adaptive trial design as they are with the more traditional study. Finding study sites can also be more problematic as the investigators may worry that an adaptive trial approach means more work for them.
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Huma enables high-quality research with a flexible approach

Huma's decentralized clinical trials platform was designed to help advance research and better enable the next generation of clinical trials to succeed. It has been designed with flexibility in mind, which can help prevent the long delays associated with mid-trial changes to keep costs low and enrollment high. With our platform, many required, approved trial changes can be made quickly, avoiding added time and cost.

Our platform enables decentralized and hybrid clinical trials with a digital-first approach to deliver effective treatments to patients faster. We’ve designed our platform to be super easy and intuitive to modify protocol changes and trial variations. Our self-serve, configurable platform gives investigators the option to easily make changes directly, or they can utilize Huma’s expert team to make the changes for them.Previous research found that clinical trial investigators were more satisfied with an electronic data system’s ability to manage mid-study changes. Huma’s decentralized clinical trial platform helps improve trial participation, diversity, engagement, and efficiency. Previous research found that clinical trial investigators were more satisfied with an electronic data system’s ability to manage mid-study changes.

Huma’s decentralized clinical trial platform helps improve trial participation, diversity, engagement, and efficiency.With an intuitive UI design, Huma’s platform supports multiple recruitment strategies to optimize participant engagement, ensuring diverse enrollment and improved retention rates.

You can also keep participants up to date on any protocol changes and testing regimes. Awarded the Prix Galien International 2022 ‘best of the best digital health product’ award for the impact of its remote patient monitoring platform across healthcare and research, our technology will help you publish updated trial guidance in the Learn module for instant visibility and review of real-time changes – minimizing the time needed for User Acceptance Testing.

The customizable dashboard provides near real-time patient data and insights regarding site and participant performance to help you proactively and safely monitor patients, improve protocol adherence, and enable faster decision-making.

As Charles Darwin famously said: “It is not the strongest of the species that survives, nor the most intelligent. It is the one most adaptable to change.”

With the abundance of DCT platforms hitting the market, users who can pivot in response to changing protocols and minimize time lost to mid-study changes will be those who are best positioned for success.