Just in Time Labeling and ancillaries: Solutions for complex trial challengesPosted on 06/02/22
I have been involved in Clinical Trials for 22 years and it is interesting to see that an already known method of clinical trial organization has come back into focus: Just in Time labeling (JIT).
Organizing a clinical trial has always required a tremendous amount of expertise, team spirit, a large portion of enthusiasm and determination, in addition to the available infrastructure. The adversity of the worldwide COVID pandemic in the last two years has intensified this and developed further creative options on how to conduct clinical trials today, such as the Decentralized Clinical Trial Distribution. However, I would like to draw your attention to a more traditional way of clinical trial distribution – JIT. This method requires a unique approach to running and organizing a clinical trial.
JIT is a useful solution for both open-label and double-blind study designs with several countries and sites involved. It is typically the best solution for titration studies / adaptive trial designs with difficult enrolment and potential medication shortage.
There are a lot of challenges to overcome including dealing with IMPs, comparators, and medical device shortages. An adequate and timely response to contingencies and unpredictable recruitment at Clinical Trial Sites is key. Sponsors need increased flexibility and speed of clinical trial sample distribution and sites must deal with the reduction of IMPs and sometimes Medical Device backlogs. Finally, the reduction of destruction and storage costs at clinical trial sites as well as in various country depots must be dealt with.
Even if these challenges are met, there are more operational challenges along the way: The provision of additional personnel and infrastructure, processes that need to be tailored to study design and an exceptional efficient teamwork and communication between sponsor, CRO, clinical team and CMO.
Finally, a more complex set-up of IT systems is needed to cover topics such as IRT, study design, approval by different country authorities, regulatory requirements per country etc. All of this is influencing the label texts and intensive forecasting and monitoring.
The link between IMP and ancillaries
JIT labeling can and should not be applied exclusively to IMP and NIMP, but should also be applied to medical devices and administration kits, with or without IMP. A detailed discussion in the set-up phase of a clinical trial is helpful to create the conditions to guarantee a smooth trial, especially the combination of IMP and ancillaries, called “kitting”. This can have further advantages for the staff at clinical trial sites such as the provision of all necessary materials by one shipment instead of several shipments, the reduction of distribution costs as well as the optimization of the overall material consumption.
Since the IRT system plays the main role in the organization of clinical trial sample delivery, among many GCP functions, a detailed and timely IRT discussion on the study-specific functions of the IRT system is recommended. For example, for one indication, it is recommended to develop modules for one study type that reflects the design of that study type and simplify setup of the same/similar clinical studies in the IRT. Standard timelines of up to three months can be reduced to 4-6 weeks to set up an IRT system including testing phase.
You have challenges – we might have the right solutions for you
At Myonex, we are happy to provide you with a project management team including key contact persons as Subject Matter Experts to offer solutions for all possible scenarios of a clinical trial implementation, e.g. the JIT. We will be there to guide you in the best possible way through this setup phase as well as all further phases of a clinical trial.
Happy to discuss the challenges of trials, JIT labeling or how we can support you with your trial: [email protected]
Vice President, Clinical Trial Packaging & Distribution (CTPD)