Why clinical trial timelines are getting longer (and how to fix it)

The development of COVID-19 vaccines in less than a year from when the virus was first sequenced was a monumental achievement. Antiviral medications for COVID have also been developed, tested, and approved in record time. 

The public may see these achievements as an indicator that drug development is becoming faster and more agile on the whole. Unfortunately, the opposite is true. The story of COVID vaccines and antivirals is a major exception to the overall industry trend. 

On average, drugs spend six to seven years in clinical trials, and trials actually take longer now than they did just a few years ago. 

According to research from the Tufts Center for the Study of Drug Development (CSDD), FDA-approved drugs and biologics spent an average of 89.8 months in clinical trials between 2014 and 2018, compared to 83.1 months between 2008 and 2013. 

Why are drug development timelines getting longer?

From securing funding to getting regulatory approval, there are many kinds of red tape that can slow down drug development. In this article, we’re focusing specifically on factors leading to delays in the clinical research portion of the timeline. 

Here are some of the reasons why clinical trials are taking longer:

Protocols are more complex

Today’s trials have more endpoints, objectives, data points, and amendments than their predecessors, and all of that makes it more difficult for clinical operations teams to run them efficiently. 

According to another CSDD study, the average number of trial objectives increased by 15.9% in Phase 1, 11.6% in Phase 2, and 17.6% in Phase 3 between 2013 and 2020.

Trials are more global

Global clinical research programs may reduce drug development timelines on the macro level, as they help sponsors avoid the need for siloed country-specific research. 

But zoom in a little, and it’s easy to see how taking a trial global can extend that particular trial’s schedule. Site initiation can take a long time, and balancing the requirements of regulators in different countries usually means amending trial protocols to include new endpoints or recruit from specific populations. In addition, there are logistical complications with establishing depots and getting drugs to international trial sites. 

Drugs in development are increasingly complex

Researchers are finding new ways to combat diseases like cancer using biologics, cell therapies, and gene therapies. In fact, some experts predict that cell and gene therapies will make up 36% of product launches in 2025, up from 16% in 2021. 

This critical research is more expensive and time-consuming than conventional drug research due to the complex nature of the products being investigated. In addition, the diseases being studied are often rare and/or hyper-targeted, creating recruitment delays related to small patient populations. 

Manufacturing, comparator sourcing, transportation, and shelf-life requirements all become more difficult with complex drugs, leading to longer timelines. 

The supply chain is under pressure

Clinical trial timelines were already getting longer prior to the COVID pandemic. However, the same supply chain issues impacting consumers worldwide following the pandemic also impacted clinical research, causing major disruptions. 

Shutdowns impacting the manufacture of ancillary supplies, restrictions hampering cross-border transportation, and an overall increase in clinical research related to the pandemic all put pressure on supply chains, creating delays. 

In addition to these issues, clinical trials have been impacted by staffing shortages, safety measures, and other COVID-related operational changes at hospital sites. 

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How clinical operations can shorten trial timelines

Many of the factors that are extending timelines are outside of the control of clinical operations teams. There’s no way to recruit more patients with a rare disease if they don’t exist, or magically make international regulators standardize their requirements (though such an effort is, thankfully, underway in the EU). 

However, there are still opportunities to optimize trials and reduce timelines. Here are three proven ways:

1. Reduce overage

On average, 55-75% of drugs in a clinical trial are never dispensed to patients.

While some level of a buffer is necessary to cover risks of missed dispensing created by unpredictable events, the truth is that most supply teams don’t know in advance the quantity of drug product they actually need and instead rely on simplified models or calculators to make estimates. 

In addition, each part of the clinical supply chain, from the manufacturing of the active pharmaceutical ingredient to the trial site, usually works out its own buffers without considering opportunities for efficiency upstream or downstream. 

When manufacturing capacity or budget are limited, the manufacture of unnecessary drug products extends trial timelines. Overage is also required for comparators which can be difficult to source, especially for complex drugs.

However, even in situations where manufacturing capacity and budget are not limiting factors, high drug waste in one trial can create delays in others by limiting available stock. 

Using advanced analytics including Monte Carlo simulations to anticipate trial demand, it’s now possible to predict the required overage rather than relying on guesses. Using risk-based clinical supply optimization, teams can understand precisely how much additional stock they need to cover any risk of a drug shortage. 

Reducing overage frees up additional budget and drug capacity to potentially increase the number of sites in a trial and accelerate recruitment, or initiate new trials on other indications. 

Using the N-SIDE Supply App to support decision-making, together with the help of  N-SIDE's experts, has been shown to reduce the waste of any trial by 20-60% by optimizing decisions about kit design, vendor selection, IRT configuration, network selection, country selection, and more. 

2. Optimize manufacturing

Clinical manufacturing often operates with little insight into trial demand. This leads to non-optimal production decisions that increase drug waste and timelines. 

With predictive models, the impacts of decisions like lot-to-lot and lot-to-demand allocation, lot sizing, and timing on the manufacturing plan can be analyzed. By integrating real-time data (e.g., patient data, failed lots, actual production yield) into the models, these decisions can be optimized for minimum waste and maximum efficiency. 

Working with N-SIDE's team of experts to implement the N-SIDE Production App presents an opportunity to challenge assumptions and make better decisions, enabling the reduction of manufacturing waste by 20-40%.

3. End-to-end optimization and drug allocation

By using a single source of truth for data throughout the clinical trial supply chain, teams can collaborate to make optimal decisions on a global level that shorten the timelines of individual trials and even entire drug development programs. 

Rather than optimizing each trial in a vacuum, teams can understand the relationships between trials and identify flexibility in supply and manufacturing. With a globally optimized supply chain that reduces overage, drugs can be allocated in a way that means the supply chain is never a bottleneck that slows down timelines, and can actually enable faster research. 

Sponsors that drive these optimizations to the core of their operations can offset some of the challenges presented by globalization, increased protocol complexity, and complex therapeutics. 

The result? Accelerated time to market for drugs that patients need.

Learn how to accelerate time to market using end-to-end optimization.