What responsibility means to us...

Every pharmaceutical company must observe extremely stringent regulations when developing and testing drugs. Clinical trials in humans are an essential part of the drug development process by establishing the safety and effectiveness of new and existing drugs. In observing the highest ethical standards for the conduct of clinical trials, Shire performs its clinical trials globally and adheres to International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines.

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involved the participation of humans.  Compliance with this standard provides assurance that the rights, integrity, confidentiality, safety and well being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trial data are credible.

We’re committed to complete transparency about our trials, and post trial data on http://clinicaltrials.gov .This allows both patients and physicians to see what work we’re undertaking and why.

• A new FDA rule on Investigational New Drug (IND) Safety reporting was implemented this year.  This new rule had a number of important implications for the analysis and reporting of clinical trials safety data.  Shire assembled an interdisciplinary task force to assess any gaps, relevant processes and procedures were modified accordingly, and all impacted functional groups were trained on new procedures.  As a result of the task force activities, Shire continues to maintain compliance with key safety-related regulatory requirements as supported by appropriate processes and staff training.
• We continued to evolve our relationships with our clinical vendors.  This has led to the selection of a number of strategic development partners in the area of clinical trial operations.   As part of the process to establish the strategic partner relationship a defined set of performance metrics is being established. Additionally, ongoing process development assists us in guiding vendor oversight and governance. These metrics and formal processes combined with the advent of operational and executive level management committees will help ensure Shire is able to maintain effective oversight of vendors.  
• Changes to rules on obtaining patients’ informed consent were mandated by FDA, and as a result, we have revised informed consent template documents to contain newly required wording indicating that study results will be publicly posted and available to study participants and that such postings will not contain any information that could identify individual patients.  This re-affirms Shire’s commitment to transparency in data posting while also ensuring patient privacy and confidentiality.  

• Develop and provide a clear consistent statement and rationale regarding study drug access for patients completing trials.