By Tracy Chase, Manager, Proposals & Training, Bellwyck Pharma Services
Sometimes, clinical trials do not succeed because of incomplete planning and a lack of contingencies for when circumstances change. As 5 Critical Steps In Developing Your Clinical Supply Chain illustrated, proper planning is critical for the success of a clinical trial. But how do you plan for unanticipated obstacles that may affect the clinical supply chain and, ultimately, the outcome of your trial? This article will provide three strategies which can help build flexibility into your clinical supply chain plans and overcome unforeseen obstructions to your trial’s success.
One of the essential elements in running a successful clinical trial is to ensure that patients receive treatments on time, every time they need them. Losing patients due to a lack of supplies and/or treatments must be avoided at all costs as patient recruitment and retention can be a challenge, and it can prolong the overall timeline of a study. This can have two major adverse impacts. First, patient safety and treatment efficacy can be hindered. Secondly, the cost of the trial can also increase. A simple incident, even for an inexpensive product, can have massive repercussions down the road. Depending on what caused the delay and how long it lasts, correcting these issues can potentially add costs.
Having flexibility in a distribution plan means that you have created a plan that is not so rigid that it won't accommodate possible changes or delays. However, it can be challenging to predict the efficacy of distribution, where patients of the trial will enroll, how frequently they will enroll, and how quickly parts of the distribution plan will be executed. By drawing on the knowledge of subject matter experts, you can gather information to support realistic projections for distribution plan timelines and supply quantities. Your contract research organization (CRO) will be able to provide guidance using historical knowledge of recruitment and treatment timelines to aid in creating an achievable supply chain plan. Additionally, the following strategies can be used to further build flexibility into supply programs.