A recent MedCity News article outlined several steps drug and device companies may use to successfully transport their product from the preclinical stage into clinical trials. The article stressed the importance of communication when attempting to enter a drug or device into the clinical stage of development. Communication was broken down into several guidelines for companies to follow:
• Staying consistent and accurate when marketing the drug or device
• Assessing the need for pre-IND/IDE meetings with the FDA
• Keeping current in the medical and scientific community
• Determining which patient groups and potential investors may be the most beneficial
This communication may be crucial in getting the clinical trial approved, enrolling more patients, etc.
Here is another article, which focuses on the significance of Sponsor-driven communication from their headquarters to the clinical staff at sites, CROs, etc. This article points out that the Sponsor-investigator relationship is crucial to the success of the trial at that investigative site.
In fact, you can find tools such as this handbook that help guide the steps to successful communication at the start of a clinical trial, and throughout the length of the trial.
Have you had experience in bringing a new drug or device from preclinical to clinical trials? What strategies have or have not worked?