Current Challenges of the Clinical Trial Industry
Clinical supply executives today have more to worry about than 10 years ago, with clinical trials having grown overwhelmingly complex. Currently, pharmaceutical research has to deal with more procedures, endpoints, protocol amendments, eligibility criteria, investigator sites, and, on top of all this, with requirements of adaptive trials. And with that lot of issues to take care of, pharma, CROs and investigators could do without worries about whether their medicines will get to trial participants at the right time, amount and dosage.
In the industry of clinical research, considered to be traditional is the following logistics model (practiced for 10 plus years):
Bulk shipment of finished patient kits to sites and depots around the world, often prior to patient recruitment
What this means is that both primary and secondary packaging, along with labeling of the study drug(s), are done at a certain central location in a single production run. This model allows to have large stocks of ready-to-use patient kits before clinical trial begins.
The quite tangible financial downside of this model consists in the fact that it leaves sponsors and pharma with a surplus of ready-to-use patient kits. With all the work done upfront – when preliminary demand forecasts are calculated basing on anticipated number of patients at each site – chances are pharma/ sponsor will have to face a waste generated by that surplus of patient kits (produced, delivered but never dispensed to patients).
Though varying by clinical study, this overage can amount up to 200% or more. If possible, some patient kits are being returned, while a certain part of them expires and is being destroyed. And the cost of this waste is generally very high considering the high cost and value of innovative biologics and drugs that presently enter clinical trials.
Why Take Such Commercial Risks?
Most sponsors knowingly undertake these commercial risks of delivering patient kits well in advance and producing overages. There are two main reasons for doing so.
- This is done in the attempt to avoid situations of supply shortfall.
- Supplying sites and CROs in advance is crucial because delivery and distribution of patient kits in some regions and countries take longer than in others.
Any adjustment in the supply plan within this logistics model adds significantly to the study’s time and cost. And adjustments may be needed in cases of wrong estimation of the number of participating sites and patients; different countries (with different languages) for the clinical supplies to be shipped to, and a number of other reasons.
This traditional logistics model used to meet the industry’s needs in the past, until the moment when medical research grew much more complex and the old model’s limitations and lack of flexibility became too evident. Examples of such research complexity are adaptive trials that allow for mid-study changes in dosing requirement or the number of investigator sites; or biologics entering R&D pipelines and requiring cold chain solutions and other types of special handling.
These conditions triggered a tipping point when pharmaceutical companies started looking for more flexible approaches to logistics for medical research.
The Rise of More Flexible Solutions
For many companies, traditional logistics model remains the best option for catering to the clinical studies these companies conduct.
However, many sponsors in the industry are introducing new approaches that can provide for their needs of speed and flexibility better. At the same time these approaches also alleviate such major shortcomings in the clinical trials supply chain as high waste and long lead times.
The process of primary packaging – consisting of getting the drug into a primary container like a blister pack or bottle – is performed in a central facility. Being uniquely bar-coded for the purposes of inventory management, these supplies have no allocation to specific patient or protocol yet.
The secondary packaging of these stocks – with country-specific labeling – takes place at regional GMP facilities worldwide. This packaging is performed after a clinical site in that region informs that they need stock of certain amount for a certain country, with patients already scheduled for the trial. This model eliminates the need for printing costly booklet labels replacing them with single panel labels that are more patient-centric, cost less and take less time to produce.
Benefits of Flexible Logistics Model
The flexible model allows to move the primarily packed stocks closer to end-users – investigator sites and patients – with delivery to sites taking days and not weeks or month like before. Thus, clinical sites can receive the supplies of the exact amount they need and at the time they need them, with no in advance bulk shipments based on estimated demand. This means, there will be substantially smaller number of patient kits that expire and need to be returned and destroyed. Depending on the clinical research, this approach allows to cut the amount of waste to 20% and less.
Besides, with kit assembly and labeling performed on demand and not in advance, sponsors can pool the same supplies for use across several protocols (and not just one), which is impossible when using the traditional model that requires each protocol to be fully packaged in advance.
Another advantage of flexible logistics model over the traditional one is that the former better suits such needs and requirements of adaptive trials as changing the drug’s dosage for patients, or adding new sites and/or countries to a study.
The industry of medical research is undergoing a very interesting period of transformation. Sponsors’ demand in faster and more efficient solutions brings to life innovative and flexible supply models that allow to make the process of drugs’ clinical research less time and money consuming.