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Shire Global

How We Operate

Conduct of Clinical Trials

October 2013

Shire is dedicated to enabling people with life-altering conditions to lead better lives. We are committed to providing innovative medicines for currently untreated conditions, ensuring that only safe, effective medicines are provided, and that they meet or exceed the requirements of global regulatory agencies. Clinical research is the process through which we can bring these innovative medicines to people who need them.

To us, clinical research is a partnership—between ourselves and doctors, nurses, regulators, academia, and patient communities around the world:

  • We plan our research in worldwide collaboration with top clinicians and academics so that our research is at the leading edge;
  • We meet with patient organizations and healthcare professionals to understand the greatest patient needs;
  • We consult with regulators in the design of our studies; and We work with payors and governments to understand where the greatest value to society lies.

Our policies, standards, and protections are predicated on the ethical conduct of research, relationships with researchers, and open communication of research and development results to ensure patient needs are considered foremost at all times.

Shire is committed to conducting high quality clinical research, which encompasses focused, responsible, compliant and intelligent studies designed to provide maximum patient safety while evaluating clinical benefit. This commitment spans across ethical and responsive trial conduct; timely, responsible, and transparent reporting of study results; and, in accordance with regulatory agencies, patient access to safe and effective treatments.

Quality and compliance

All of Shire’s clinical studies are designed and conducted in accordance with accepted scientific and ethical standards, regulatory requirements, and local law, adhering to the ethical principles of Good Clinical Practice (GCP) contained in the International Conference on Harmonization Good Clinical Practice: Consolidated Guideline. These guidelines provide an internationally accepted ethical and scientific quality standard for trial design, conduct, recording, and reporting.

  • We are committed to conducting research activities of the highest quality standards and maintaining a rigorous quality system focused on a continuous improvement model across all areas of our business.
  • All investigators and medical staff who participate in Shire-sponsored clinical studies, wherever in the world they are conducted, must be trained, licensed, and competent in conducting clinical research. We ensure high standards are maintained in every country and for every site.
  • Shire provides stringent oversight before, during, and after a study to ensure clinical research sites follow the protocol for the study and adhere to Shire’s policies and procedures, local regulatory requirements, good clinical practice obligations, and ethical standards.
  • Health care providers who participate in Shire-sponsored or supported medical research will be paid fair market value for performing study procedures and collecting relevant data. Payments are made only for legitimate, reasonable, and necessary services directly related to the trial. We do not and will not pay health care providers for rewarding past or altering current/future prescribing practices, or to learn about or gain experience with Shire products.
  • Only high-quality and well-suited service providers and other vendors are selected as partners to perform clinical study services. All partners and suppliers must agree and adhere to industry and regulatory standards, as well as Shire’s standards and values. Selection of a service provider is not contingent upon their purchase of Shire products or any other means of preferential selection.

Trial purpose

Shire sponsors and supports medical research for the sole purpose of answering important scientific and health care questions that help meet currently underserved or unmet medical needs.

  • Clinical research will only be undertaken or sponsored by Shire if the anticipated benefit of the investigational product to society outweighs\ the potential risk to the trial participants.
  • A qualified and independent ethics committee must review and approve all Shire clinical studies prior to initiation of that study.

Rights and recruiting of trial participants/volunteers

All Shire-sponsored clinical studies are conducted with respect for the privacy, rights, safety, and well being of study participants. These are the most important considerations. Although participants receive appropriate medical care during the clinical trial, we ensure our participants understand that participation in a clinical trial is not a replacement for regular medical care and that it does not prevent a patient from receiving or seeking regular medical care during or after the trial.

  • Trial participants are free to leave the study at any time without loss of benefits.
  • Shire will cover medical costs for trial participants who suffer injury or illness from trial participation.
  • Prior to enrollment in a clinical study, study participants must provide freely given informed consent in accordance with national cultures and requirements; this ensures study subjects have an understanding of the study purpose, risks, and benefits.
  • When a potential trial participant is not capable of providing informed consent, the permission of a legally authorized representative will be obtained in accordance with applicable laws, regulations, and ethics standards.
  • Informed consent will also make clear provisions for post trial care.
  • Compensation to trial participants (with the exception of healthy volunteer studies) is provided in a way that will not influence enrollment decisions or participants’ decisions to enter or leave a study. Compensation is designed to reflect local economic conditions and reimburse costs of taking part in the trial.
  • Due to the specialist and rare nature of the conditions our medicines treat, statistically we need to go further afield to find eligible patients and this means we often need to seek trial participation from individuals in countries where the investigational product may not ultimately be approved and/or commercialized.

Post trial access

While we have an important role in improving developing and making available new medicines, we believe that providing access to treatment is primarily the role of regulators and governments as part of their national healthcare programs. However, there are certain circumstances when continued access to a study medicine is necessary and appropriate, and in these cases Shire is committed to considering each request for an extension of therapy in the context of existing local legal and regulatory framework. In addition, we have a number of programs in place to enable greater access such as charitable access, named patient supply and patient assistance programs.

Trial results disclosure and publication

Shire believes in the responsible disclosure of trial information. We are dedicated to transparency that respects both our proprietary information and patient confidentiality while allowing access to important data that can benefit public health—which is released in a consistent and considered fashion.

  • All Shire-sponsored trials are registered as required by local regulations within local regulatory timeframes. This allows people to see what work we are undertaking and why.
  • Shire-sponsored trials are publicly disclosed via www.clinicaltrials.gov, the EudraCT database made publicly available by the EMA, and via the clinical trials register at www.clinicaltrialsregister.eu.
  • Shire will make summarized trial results available for trial participants as per applicable regulations so they can understand the outcome of the clinical investigation. We also encourage investigators to provide a summary of trial results to their patients.
  • We encourage investigators to partner with us in publishing the results of Shire studies in peer reviewed journals and we comply with the International Committee of Medical Journal Editors’ “Uniform Requirements for Manuscripts Submitted to Medical Journals.”

For additional information on Shire’s clinical trials, please visit www.ShireTrials.com.

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