Opiate Clinical Trials Complications

Addressing complications in opiate clinical trials

It’s a particularly difficult challenge that goes well beyond proving safety and efficacy: to retain the effectiveness and palatability of the drug while making it unattractive to abusers. We approach it by:

  • Selecting sites that have the proper licensure and experience working with opioid products for treatment of chronic pain.
  • Training and assisting investigative sites to manage the security requirements and paperwork necessary for Class 2 products.
  • Helping sites manage adverse events associated with opioid treatments to minimize patient dropouts and the subsequent loss of data.
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