Getting a potential new therapy through the clinical trial process takes more time than ever before. Protocols are growing increasingly complex. Plus, many trials have trouble enrolling enough patients, and those who do enroll may have difficulty following the protocol and drop out. Complicating matters further, many drugs being developed are expensive biologic agents, leaving little margin for error in the clinical trial strategy.
Delays in getting a therapy approved mean less time to secure commercial success and recoup investments before generic forms are available. Most importantly, it delays getting potentially lifesaving drugs to patients. As a result, sponsoring companies look for ways to trim development timelines.
Establishing an efficient drug packaging strategy for a clinical trial is not often recognized as a potential timesaver, but it should be. A well- thoughtout packaging strategy can significantly cut your clinical trial timelines and increase the likelihood of a successful trial.
There are several critical factors that sponsors need to consider about packaging: the drug’s form requirements (injection, oral solid dose, etc.), the volume needed for the trial (lot size, trial duration), temperature requirements (freeze/thaw cycles, handling requirements), and whether the drug needs to be protected from light.
This ebook outlines how considering your product will be used by patients and healthcare providers involved in your clinical trial is important along with recent trends that should be taken into account when thinking about clinical trial packaging options.