A universal truism across all commerce is that automation can be an extremely powerful tool, however, if not designed, configured and managed appropriately, it can yield disastrous results. There is perhaps, no space in which this is truer than that of the BioTech/Pharmaceutical industry. With drug and product development costing upwards of $2.5 billion to go from discovery to market, and a very short window to earn back investment capital and profit prior to losing patent protection, companies have to ensure that the right decisions are made the first time at every single step1.

One of the most perilous periods of drug development likely to cause delays, is the clinical trial phase.  Companies need to do everything possible to protect themselves from a multitude of potential points of failure during this stage that can cause costly trial interruptions including but not limited to un-blinding, inventory stock outs and product wastage. To put into perspective just how important it is to navigate through these items, consider that a company typically only has 10 years between market approval and loss of patent. This means that they must earn back nearly $700,000/day just to break even, let alone make a profit, so reducing risk of even a few days can translate to over a $1 million in savings that can be contributed toward the bottom line.

IRT is a Valuable Tool, but a bit of Black Box

Interactive response technology (IRT) is one of the most valuable and efficacious means of ensuring that risks of trial delays are mitigated through use of mechanization to manage clinical data and the supply chain. Unfortunately for many people who manage clinical trials, IRT is a bit of a black box, often misunderstood or under-rated. Some of the more well-known trial activities that it can accomplish include patient randomization, drug assignment and dose calculations… but these barely scratch the surface of capabilities.

Because IRT has a software base, it can be programmed with customizations to accommodate whatever the designer can envisage, from concepts as mundane as determining which product to send to which countries based on product labels, to as imaginative as sending a text message to a patient’s phone to remind them to take their medication. With stakes that are so high, ensuring that system capabilities are optimized to manage the needs of an individual clinical trial can be invaluable to the success of a company. In order to maximize the probability that a system is reaching its full potential, there are several items that should be taken into account, including IRT vendor/service selection and level of system complexity.

It is not practical for most companies to have an in-house IRT development team, therefore, very often work is outsourced making vendor selection of paramount importance. When selecting a vendor, it is imperative to consider vendor size, which will oftentimes indicate relative cost, experience and most importantly, level of priority given to the purchaser. While it’s obvious that larger companies will often have more experience, they also carry more overhead, so service will likely be more expensive.

Four Key Questions to ask during Vendor Selection

Matching vendor size with purchaser size is key in long term success, as the selection of a vendor that is too big may result in a lack of priority given to the purchaser. However, selecting a vendor too small may result in resource constraints in being able to meet purchaser demand. Unfortunately, ensuring that vendor size is comparable can be difficult, as no salesperson is going to admit that their company is either too big or too small to accept the business of a purchaser. Therefore, some due diligence needs to be completed during the vetting process. Asking the following questions can give purchasers valuable information that can be used to create metrics that will indicate which vendors would be best:

  • What are the average number of live IRT systems/employee?
  • What are the average number of projects/project manager?
  • What are the average number of incidents/IRT system?
  • What is the average value of a client account?

While getting answers to the above questions will not indicate which vendor translates to the best choice, doing so will add color to the overall picture. Perhaps the most important metric to determine at the start of vendor selection is the ratio of the purchasing company’s account to the vendors average sized client account. The lower a purchaser’s account compared to the average, the higher the probability that the purchaser will be deprioritized by the vendor, which can lead to poor performance, missed deadlines and ultimately, significant delays that impact the trial itself.

The 7 Deadly Sins of IRT Implementation

Determining the level of complexity that your system should have built into it is also important to consider. Balancing budget and timelines with prioritized clinical necessities can help make this determination easier. Involving the vendor to give guidance as to which functionalities might be able to assist with reaching the most important goals can add a tremendous amount of value. After a vendor has been selected and a purchaser is planning for IRT implementation, there are seven key challenges (lovingly referred to by this author as the seven deadly sins of IRT implementation) that should be noted and overcome:

  • Incorrect system specification/poor design: Ensuring that an appropriate amount of time and thought has gone into system design from the onset is invaluable. Involving all relevant stakeholders is key to this process. While amending the system later with missed requirements is possible, it’s expensive and adds the risk of breaking existing functionality by adding new software code
  • Faulty metadata configuration: Metadata values drive system performance. Developing a thorough understanding of which data points drive functionality and how they should be populated is essential. Your IRT vendor can assist with this
  • Lack of attention to User Acceptance Testing (UAT): UAT is an opportunity to test drive the system. Using expert experience to devise methods to test real world scenarios will ensure that most system bugs are identified prior to using the system for trial management
  • Starting the requirements gathering process too soon/too late: Clinical trial planning is extremely volatile, and protocols can change frequently, even after approval. If you start gathering IRT requirements too soon, you may design a system with obsolete functionality. If you start too late, you compromise timelines
  • Failure to communicate updates to the protocol in a timely fashion to the IRT vendor: What may seem like an insignificant protocol amendment from the clinical operations standpoint, may actually be a major update to software. The sooner updates are communicated to IRT vendors, the better
  • Over-reliance: Do not rely on IRT to manage your trial with absolutely no oversight. Remember, it’s been coded by a human and so is prone to have errors. Using IRT reports to monitor operations is a prudent means to ensure performance is as expected
  • Asking for more/less than what’s needed: While IRT can offer nearly anything that the designer can imagine, it’s important to keep systems practical and as simple as possible. As complexity increases so does so too do the number of potential break points. Conversely design a system with inadequate abilities to meet trail needs will likely necessitate a costly and risky future amendment

In closing, it’s important to point out that like all technologies, IRT is growing in importance and making advances every day. Understanding how to utilize it to its full potential will allow users to more accurately project clinical supply demand, waste fewer products and reduce risk of depot or site level inventory stock outs. Ultimately, all of this leads to an earlier trial completion, allowing companies to maximize income prior to the patent of a product expiring, which offers a significant competitive business advantage.

 

 

Anthony Zuccarello

Associate Director of IRT and Global Clinical Supply Strategy

Amicus Therapeutics

 

 

References:

1) https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/