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In order to obtain marketing authorisation for a new medicinal product, the trial sponsors must test against the current market leader: more commonly known as a comparator drug. Clinical trials must demonstrate that the innovative drug is effective and safe for patient use before it is approved, and rigorous testing under trial conditions is the only way to prove this. In order to source these products successfully, one needs to have a partner competent at procurement, with an in-depth knowledge of the pharmaceutical marketplace within the EU, North America and the rest of the world. Many sponsors and their agents believe this is the easiest part of the clinical trial, and do not plan for it from the outset. This article aims to dispel some of the confusion surrounding the process of comparator procurement, and reveals some of the considerations that need to be taken into account as part of the clinical trial protocol.
Fortunately, it is accepted within the pharmaceutical industry that, in order to bring innovative medications to market, each trial sponsor needs to be able to access comparator drugs for use in clinical trials, and there is general agreement throughout the industry that manufacturers will cooperate with requests for their product to be made available for such use.
EARLY ACTION
Requests for comparator drugs are typically significant in quantity, and are required to be from a single batch, supplied with supporting paperwork such as a Certificate of Analysis, MSDS, TSE/BSE statements and pedigree documentation. The amount of comparator drug requested will reflect the number of patients recruited to take part in the trial, while the provision of product from a single batch seeks to ensure continuity of results. Samples may be requested ahead of a larger order to enable an evaluation of the product and its packaging. Supply from a single batch will allow any relabelling or repackaging procedures to be centralised, ideally reducing time, cost and effort. The expiry date of the product will also be scrutinised to ensure that the comparator lasts until the end of the trial. For those products with a relatively short shelf life, one needs to plan for regular resupply during the trial’s duration. To ensure that all these factors are taken into account, a planning team must take early action with the comparator provider to ensure that the trial takes place on time and within budget, and that there are no supply shortfalls during the lifespan of the trial. |
