Packaging for Clinical Trials: Special Considerations and Trends
26 Jul 2021
The amount of clinical trials that are carried out each year globally has grown exponentially. If we take a look at the United States’ portal ClinicalTrials.gov, the number of clinical trials has multiplied by 250 in the last 20 years, going from 1,295 annual projects in the year 2000 to an astronomical 325,787 at the end of 2020. A direct consequence of this trend has been an increase in the demand for packaging geared towards clinical trials.
In today’s article we analyse how this type of highly specialised packaging is evolving, and which features should be considered when designing and manufacturing it.
Special features in packaging for clinical trials
The packaging used for clinical trials usually consists of a primary container (vials, blisters, among others) and a secondary packaging, which is often composed of a carton and a label. As for leaflets, are only used if a Medical Device requires instructions for use.
There are a few distinctive features in particular that separate packaging for clinical trials from the pharmaceutical market packaging:
- This type of packaging never sits on the shelves in chemists, which means that the features related to the packaging’s appearance are not quite so relevant; instead, aspects such as Pack integrity and Blinding of the packs across Active drug, placebos and comparators are key issues.
- Concerning Clinical Trial units, there are both low and high volumes. Furthermore, studies are growing across various countries which requires more languages of a packaging, a challenge that can be achieved with our hybrid printing capabilities.
- The labelling regulations are very strict and labels must comply with specific regulations (Annex 13 for Investigational Medical Products labelling).
- Generally, the substances used in clinical trials require special storage conditions Such as low temperatures from ambient to cryogenic.
Packaging for clinical trials: challenges faced today and yesterday
When it comes to designing packaging for clinical trials, pharmaceutical companies face the following challenges:
1. It is necessary to respond diligently to the demands for clinical trial packaging
Not complying with the deadlines established in the development of new treatments has a severe financial impact, which is why pharmaceutical companies demand integral packaging solutions that take into consideration the planning for each phase, and are adapted to the specific needs of each clinical trial.
2. The direct-to-patient strategy is increasingly established
Because of COVID-19-derived restrictions in healthcare centres and laboratories, many facilities have opted to develop tests within the framework of long distance clinical trials. According to a report by Medidata, 45% of participants in the survey applied this solution in order to continue advancing the studies despite the pandemic.
Nonetheless, the implementation of clinical trials at the patients’ homes is not without challenges. The lack of medical professionals’ assistance has brought to the attention of pharmaceutical compan
ies the need for packaging that is adapted to the new situation. This means including accessible instructions for every type of patient, and packaging to assist with adherence (for example: blister wallets,)
3. The packaging’s labelling should prevent the unblinding of the clinical trial
A common procedure in clinical trials is the use of test randomisation (double-blind trial), which implies assigning the treatment to each group of patients in a random way, without healthcare professionals nor participants being aware of it. The purpose of this tactic is to delete selection biases and therefore be able to compare objectively the effects of each treatment.
4. Adapt to new regulation changes
The regulations that oversee the development of clinical trials are under continuous review. In fact, the European Union is currently revising the legislation that regulates labelling in materials used for clinical trials. Therefore, it is forecasted that by the end of 2021 there will be changes in the labelling conditions established by the Regulation EU No 536/2014.
If this does indeed happen, pharmaceutical companies will have to face new challenges related to the identification of packaging for clinical trials (Annex 6), just as described by the EFPIA (European Federation of Pharmaceutical Industries and Associations).
Are you looking for a provider who specialises in pharmaceutical packaging for your clinical trials? At Essentra Packaging we have a team of experts who are dedicated to this very field. Contact us here, and our professionals will be delighted to help you.