Keeping Cool

With an increasing number of clinical trials being conducted internationally, maintaining control of the drugs being trialled is more difficult than ever. This is particularly problematic when the drugs are temperature-sensitive as they commonly have to be transported over considerable distances and, potentially, through multiple climate zones. The repercussions of providing inadequate control measures are considerable, at worst risking the safety of volunteers and the success of the trial. For this reason, choosing the right packaging solution for any trial is essential.

OBSTACLES TO MAINTAINING CONTROL

The factors that make maintaining control so difficult are varied. One of the most problematic is the sheer distance that the drugs now have to travel. With the populations where trials have conventionally been carried out now swamped with prescription and off-the-shelf drugs, sponsors and research organisations have to look to more far-flung countries and regions for noncontaminated test candidates. The logistical challenge of safely shipping drugs over the long distances between the organisation’s base station and the location of the trial are considerable, and far greater than those previously encountered.

For instance, maintaining a consistent and acceptable temperature for sensitive drugs over routes where they are subjected to extreme weather conditions and temperatures, often varying considerably over the duration of the journey, can be particularly difficult. Furthermore, the challenge doesn’t end when the drugs reach their destination; many of these regions are typically prone to high temperatures and extreme humidity. In addition to these conditions, the length of the distance involved can itself be a problem, with many temperaturecontrolled solutions unable to offer adequate protection over an extended period of time.