Comparator Sourcing in Clinical Trial - Risk or a Safe Bet?

1. Comparator Sourcing in Clinical Trial: Risk or a Safe Bet? 1

2. Comparator Sourcing in Clinical Trial: Risk or a Safe Bet? To get started right away, just tap any placeholder text (such as this) and start typing to replace it with your own.Comparator Sourcing in Clinical Trial has tend to become risky, thanks to the burgeoning pharmacy industry and competitiveness in the market. Day by day, developers, manufacturers and patients are expecting a better product than the existing one and that too at moderate price, irrespective of their weak supply management. It’s important to get the process of comparator sourcing right as its demand has increased and payers are now turning to global markets to fulfil their clinical needs. However, comparator sourcing strategy might be challenging and not always be effective. So, the question arises whether comparator sourcing is a risk or a safe bet. Here are some of the key factors that one need to watch out while looking for optimal clinical trials. Understanding Comparator Sourcing Comparator Sourcing in drugs and medicines is like a new wave in the clinical field. While the fact remains that most of the drugs are thoroughly researched and investigated for 10-14 years before entering the market, it doesn’t take long for competitors to launch the product with similar combinations and affordable rates. Nevertheless, as per the pharmacy industry, comparator drug testing is essential in drug development as the industry pushes research boundaries and improves patient care. 2

3. What are the risks involved? No doubt, comparator sourcing draws a fine line between profit maximization and medical advancement. While manufacturers tend be hesitant to supply their product as a comparator for a clinical trial as this could lead to their drug being superseded by a competitor’s product and eventually lead to loss in the revenue, trial sponsors see comparator sourcing as challenging both politically and from a supply chain perspective. The common risks involve: 1.Lack of trust between the developer/supplier and wholesalers 2.Confidentiality is not assured 3.Apprehension in opting trial products over the existing one 4.Financials risks in the transactions How can one avoid risks? 1.Planning in advance Adopt a comprehensive view. One needs to understand that comparator sourcing in clinical trial requires advance planning and ability to mitigate risks at the same time. There should be a strategic plan where one should evaluate all the sourcing factors right from managing the supply chain to conclusion of the clinical trial. These include: Evaluating regional variations of comparators, including dosage form, API concentration, and regulatory agreements related to the equivalency of different comparators Reviewing sourcing options for regulatory requirements, packaging, reformulation, blinding, and relabeling needs Establishing required volume/quantities and delivery schedule Evaluating price and total cost of acquisition of comparator 3

4. A proper research on collecting relevant facts like sourcing country, duration, strength and maximum volume of the comparator is also required. Proactive demand planning that can rapidly accommodate changes in the quantity of comparator needed in light of fluctuating patient enrollment or unexpected changes to a trial. 2.Build relationships Experts suggest that building healthy relationships with pharmaceutical manufacturers to give the clinical trial team access to authentic, commercially available drugs, as well as confidential, strategic advice can help avoid costly delays. 3.Lack of cost-efficient clinical trials A recent study shows that there are challenges in the supply chain management practices due to high cost of newer products. Most of the clinical trials compare investigational drugs to placebos rather than pitting a drug in development against an existing treatment. This is not ethical. Sponsors must put in concrete strategies to first select a comparator drug and then source and supply that drug, in a cost-effective manner. 4.Choose the right credible sources Wholesalers may or may not promise authenticated documents and hence, a need arises to source the products through comparators. It’s possible that a wholesaler might offer products at cheaper rates but it’s always safer to follow the credible course of clinical trials. It also minimizes the risk of any unexpected costs. Many sponsors also opt for single sourcing so as to avoid the problems of multiple comparator sources and to ease the demands on internal supply. Nevertheless, the implementation of a robust management practice always results into painless clinical 4

5. trials. Single sourcing also reduces the issues of local supply and works within the regulatory frame. In a nutshell, comparator sourcing requires thorough understanding of the market. This includes advanced planning, identifying the market, cost-effective clinical trials and linking to credible sources and following a strategic approach in an ethical manner. 5