Conduct and transparency of clinical trials
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 involve 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 remain dedicated to the safety of patients who take part in our trials, and uphold the highest ethical standards in all of our clinical research. All of our clinical research must be reviewed by a qualified Independent Ethics Committee or Institutional Review Board. Furthermore, we’re fully committed to complete transparency about our trials. This allows both patients and physicians to see the clinical research activities we’re undertaking and why. Shire has adopted national and international principles and standards regarding disclosure of information about our clinical trials. Shire registers clinical trial protocol information in a publicly accessible clinical trials registry at www.clinicaltrials.gov. Additionally, clinical trial protocol information submitted by Shire to the EudraCT database is made publicly available by the EMA via the clinical trials register at www.clinicaltrialsregister.eu.
Reflecting on 2012
- Continued to develop and improve our ability to provide uninterrupted access to medicines for clinical trial participants completing Shire-sponsored clinical trials. We value the commitment made by our clinical trial participants and are equally committed to providing continued treatment whenever possible. Shire’s Access to Medicines programs provide an opportunity to continue treatment for these patients when there is a gap in the availability of our products between the time a clinical trial has concluded and commercial availability of the medicine. Each trial participant is evaluated for eligibility for continued treatment and the most appropriate approach for access to product is identified.
Commitments for 2013
- Enhance patient focus in clinical research. Shire will investigate and develop means to provide patient(s)/subject(s) access into the clinical trial protocol development process. Shire believes that by building a mechanism to incorporate direct feedback from patients, it will provide a socially responsible and transparent method in improving clinical trial protocols.
- Improving Study Drug Availability. Issue a policy statement around access to medicines in the developing world, focusing on drug development activities and product availability.
- Further explore and identify potential mechanisms to enhance transparency and public access to our clinical trial result.
- Develop a policy/position formalizing clinical trial transparency reporting principles.
"As a new sponsor for the area of clinical trials, I will be focused on helping to make sure we continue to meet the needs of those who need our treatments, and the specialist physicians who treat them, and to ensure that we are regularly reviewing and improving our efforts to uphold the highest ethical standards in our research and development practices."
Jeremy G Chadwick, PhD
VP Sponsor of Transparency of Clinical Trials
Our approach to clinical trials
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