It’s good to see drug developers addressing the issue of comparator drug sourcing and working hard to change the way they manage comparator products in clinical trials. Getting comparator sourcing right is crucial because there is increasing pressure from patients and payers to develop drugs that are substantially better than existing treatments. But managing comparator drugs has grown vastly more complex in today’s environment; where clinical studies are conducted in remote locations and biologics development demands sophisticated cold chain supply capabilities.
As I noted in a recent post, leaders from the research-based drug industry discussed the comparator issues at a roundtable discussion convened by the Tufts Center for the Study of Drug Development.
One of the most pressing challenges they identified was a lack of fully robust supply chain management practices. After working extensively with clinical teams on comparator sourcing for the past several years, I agree. A major reason for this supply chain weakness is that companies are so shocked at the high cost of purchasing comparator that they become overly distracted by this line item rather than looking how they could save money and mitigate risks overall by taking a more strategic approach. We address the importance of thinking strategically and avoiding a procurement-driven mindset in a new e-book on the subject.
When it comes to comparator drug sourcing for clinical trials, there are four essential elements to make the process as painless as possible.
- Get ahead of the game. Ideally, begin planning a comparator sourcing strategy in protocol development, before the clinical trial begins. Advance planning provides maximum flexibility and options, and enables the ability to better identify risks.
- Identify relevant facts. For planning purposes, it’s necessary to list key details about the clinical study—including countries, number of sites and subjects, duration, strength and maximum volume of the comparator. These are required to accurately predict supply needs and conduct the planning work necessary for reaching optimal solutions.
- Adopt strategic thinking. Sourcing comparator for clinical trials is not merely a purchasing or procurement exercise. Taking a strategic approach requires “big picture” thinking to evaluate every sourcing factor and create a customized plan with multiple options. Remember, the ultimate goal is managing the supply chain from day one through the conclusion of the trial.
- Select a single partner that is known, trusted and experienced.The rule to follow is a simple one: When conducting a comparator trial, the fewer touch points the better off you’ll be. Fisher Clinical Services offers a fully integrated approach to supply chain management. This includes comparator drug sourcing, blinding, packaging, labeling and distribution—making the whole process efficient in terms of time and cost. Fisher removes risk from the supply chain through:
- An unmatched geographic footprint with the capabilities and capacity for central and local sourcing, regulatory support and transportation management in Asia, Latin America and Eastern Europe, as well as the United States and European Union;
- An established sourcing network of trusted industry relationships that enables us to acquire comparator products directly from innovator companies or from qualified wholesalers at favorable pricing thereby reducing both the costs and risks of counterfeit drugs;
- The financial strength necessary to support procurement activities in an efficient way that limits financial risk.
Advanced planning, a thorough analysis of the clinical protocol, strategic thinking and an integrated supply partner. All of these considerations will go a long way toward making comparator trials less costly and frustrating.