The world of clinical trials is constantly evolving, and with that evolution comes an increasing need for innovative approaches to sourcing the right drugs. One of the biggest challenges facing clinical trials today is comparator drug sourcing. Comparator sourcing is critical to a study’s success, and getting it right can significantly affect the trial’s cost and timeline.
In this blog, we will explore the complexities of comparator drug sourcing and the emerging strategies that help optimize this vital aspect of clinical trials. From the challenges posed by biologics to the importance of reducing drug waste, we will dive into how cutting-edge technology can help overcome the traditional hurdles and develop cost-effective comparator sourcing strategies.
What Is Comparator Sourcing for Clinical Trials?
In clinical trials, comparator drugs are essential in evaluating the effectiveness of a new investigational drug. These are pre-approved medications that are used as a standard or benchmark against which the new drug is tested. The role of comparator sourcing is to ensure that the trial is supplied with the appropriate comparator drugs, in the right quantities and at the right time, to ensure the validity and success of the trial.
Traditionally, comparator drugs were often available in abundance and with relatively stable pricing. However, as the landscape of clinical trials has evolved, the task of comparator drug sourcing has become significantly more challenging.
The Growing Complexity of Comparator Sourcing
One of the primary factors contributing to the difficulty of comparator drug sourcing is the increasing number of biologics and innovative drugs required in clinical trials. Unlike traditional small molecule drugs, biologics are more complex and come with a host of unique challenges. They are more expensive, difficult to produce, and have a limited shelf life. Biologics often require cold storage and special handling, making them even more complex to source and distribute for clinical trials.
Moreover, the growing complexity of clinical trials, combined with global regulations and an increasingly globalized market, has made predicting the demand for comparators more difficult. Sponsors face the additional challenge of managing the supply of these drugs in regions with varying regulatory requirements, which can create delays and increase costs.
In light of these challenges, sponsors are often forced to allocate significant portions of their budgets to ensure the reliable comparators sourcing for clinical trials. But budget alone is not always enough. The constraints of comparator manufacturing, particularly for biologics and other high-demand drugs, can extend timelines and even threaten the success of the trial.
The Challenge of Drug Overage in Clinical Trials
A crucial element in comparator sourcing for clinical trials is the concept of overage. Overages refer to the extra supply of comparators sourced to account for uncertainties such as patient dropouts, delays in supply, or unexpected changes in patient needs. Because clinical trials often have an element of unpredictability, supply teams source more drugs than are required to ensure there is enough to meet the trial’s needs.
However, as comparator drug costs rise, so does the cost of overage. The waste associated with overage has come under increasing scrutiny, particularly as the price of comparators has escalated. For clinical trial sponsors, the challenge is how to accurately estimate overage levels without wasting valuable resources or budgeting excessively.
How Technology Reduces Comparator Overage?
Thankfully, new technologies are emerging that can help clinical trial teams reduce the necessary overage of comparator drugs. Traditionally, overage levels were calculated using thumb rules or based on data from similar trials. While these methods worked in the past, they can result in overestimates of required drug supplies, which ultimately lead to increased costs.
There are several innovative solutions to this problem, such as an advanced tool that uses sophisticated analytics to simulate trial conditions and assess a variety of risks. Then it can provide precise overage recommendations based on the specific circumstances of the trial, rather than relying on generalized assumptions or past experiences. By using risk-based optimization, this tool can enable clinical trial teams to reduce unnecessary drug waste and lower the overall cost of comparator sourcing.
Key Ways to Optimize Comparator Sourcing
1. Increasing Sourcing Frequency
Initially, the company had planned the comparator drug sourcing every five months. However, due to the short shelf life of the comparator and the potential for expiry replacement events, this sourcing frequency presented a significant risk. If delays occurred, the company might be forced to discard large quantities of a drug.
By shifting the sourcing frequency to every two months, the company was able to increase the overlap between supply campaigns. This reduced the waste associated with expiry replacement events and allowed for a more flexible and responsive supply strategy.
2. Finding Additional Shelf-Life
Shelf life is a crucial factor in determining comparator drug overage. While shelf life is often thought of as fixed, there are ways to optimize this factor. For example, by selecting manufacturers with shorter lead times or more efficient production processes, the company could reduce the time between production and release, effectively increasing the usable shelf life of the drug.
3. Optimizing Trial Visit Interval
The initial trial design included a three-cycle visit interval, with each cycle lasting four weeks. This extended visit interval, coupled with high patient dropout rates and frequent titrations, contributed significantly to drug waste and budget overages.
Conclusion
Comparator drug sourcing remains one of the most challenging aspects of clinical trials. As the demand for biologics and other innovative drugs increases, the complexities of sourcing comparators have only grown.
By utilizing risk-based optimization, sponsors can ensure that they are sourcing the right amount of comparators—no more, no less—while minimizing the financial burden of overage. The result is a more efficient, cost-effective approach to clinical trial drug sourcing that benefits both the trial sponsor and the patients who rely on these groundbreaking treatments. As clinical trials become increasingly complex, optimizing comparator sourcing for clinical trials will continue to be a key factor in ensuring the success of studies and the accessibility of innovative therapies to those who need them most.