Not much changes very often, or very quickly, in the world of pharma packaging innovations for clinical trials—but there are a few
trends.
Protecting ‘The Blind,’ Maintaining Consistency
Although pharma packaging may seem simpler to produce because it is
designed to look generic, certain aspects can be more difficult. It is critical
for a clinical trial package to ‘protect the blind.’ Everything —from the positioning
of any printed elements to the color—has to look exactly identical. Even slight
variations are unacceptable.
The ‘Blinding’ Process
Typically, customers will send the supplier the products that will be used
in a trial, and Bilcare works with customers to find design solutions. The pharma
packaging is “blinded” by being redesigned and altered, to ensure that no one
will be able to spot any differences. This is necessary when a trial is
comparing the effectiveness of two different drugs. Often, a drug that is
already approved and on the market is being compared to a new one.
Utilizing Technology to Increase Productivity
Bar codes, when used on clinical trial packaging, can be another way to
“protect the blind.” Suppliers say they also help make the randomization
process more efficient. Bilcare have more packaging solutions that often
incorporates bar code printers, as well as track and trace capabilities, into
machinery lines for customers using its automated equipment. They often prints
2-D bar codes on labels for products that will be sent to a trial. The codes
contain randomization and blinding information. This leads to shorter
production times, quality improvement, and cost reduction. There is an initial
investment in hardware and software, but the long-term savings can be well
worth it, especially for larger trials.
Utilizing the Blister to Increase Patient Compliance
Some suppliers say calendarized blisters have become much more popular for
clinical trials. So these blisters help ensure the patient adheres to a
specific dosing regimen. Generally, blisters are more compliant, especially if
titration is involved or the patient needs to take two different products. A
blister may also be dictated due to the stability of a drug.
Electronic Solutions
Packages that electronically monitor patients’ dosing regimens have been around
for more than 10 years and are only now slowly increasing in popularity. The
market is beginning to develop. Electronic adherence packages are now being
considered by drug developers as a tool to collect data. In most cases, the
data captured is the date and time patients remove medicine from the package. A
bottle cap, with a built-in timer, is one type of electronic monitoring system.
Responsibilities Shift in the Future
Pharma companies are outsourcing many new types of jobs lately, which have
traditionally been done internally. Bilcare is one supplier that has been taking on additional
responsibilities that have included managing the entire supply chain.