Kite is dedicated to openly sharing data from our clinical studies. We believe that transparency aids in enhancing science and medicine, benefiting not only the patients of our products and potential treatments, but also the medical professionals prescribing them.
Kite provides this information consistent with the need to protect patient privacy, publication rights and proprietary information. Details regarding the pipeline of investigational medicinal products by Kite can be found at www.kitepharma.com/cell-therapy/pipeline. Additional information regarding specific Kite clinical trials can be found on publicly accessible registries, including ClinicalTrials.gov (CTgov) and European Union Clinical Trials Information System (EU CTIS).
While we make every effort to provide information about Kite clinical trials, we recognize that some trials may not appear on our website when there are legitimate reasons to exclude them. Examples include when there exists an agreement with a third party preventing Kite from disclosing information about the trial; when necessary to comply with medical journal requirements; or due to considerations regarding patent application filings.
If you have a specific inquiry regarding Clinical Trial Disclosure and Data Transparency commitment or practices of Kite, please contact us at kitemedinfo.com and 1-844-454-KITE (1-844-454-5483).
Our policies
Kite registers clinical trials on clinical trial registries such as ClinicalTrials.gov (CTgov) and European Union Clinical Trials Information System (EU CTIS) as required by law and/or regulation, and in accordance with local requirements.
Kite ensures that applicable clinical trials are registered prior to the first patient being consented for the study. Registration prior to first patient consent is aligned with the International Committee of Medical Journal Editors (ICMJE) guidelines.
Kite discloses summary clinical trial results, regardless of the outcome of the trial, as required by law and/or regulation. This includes Kite-sponsored clinical trials that have been registered on publicly accessible clinical trial registries.
In the USA, summary results are posted on ClinicalTrials.gov (CTgov) no later than 12 months after the study's primary completion date for all Kite-sponsored studies related to an approved product. A full definition of primary completion date can be found in the ClinicalTrials.gov study glossary.
For studies with a primary completion date prior to January 18, 2017 and related to products that have not yet been approved or are being investigated for new uses, Kite posts summary results on ClinicalTrials.gov (CTgov) within 30 days of receiving regulatory approval. For studies with a primary completion date after January 18, 2017 and related to products that have not yet been approved or are being investigated for new uses, Kite posts summary results within 12 months of primary completion date regardless of approval status.
In Europe (EU and EEA), summary results are posted on the European Union Clinical Trials Information System (EU CTIS) no later than 12 months after the trial Last Patient Last Visit Date (LPLV) for trials with adult participants and no later than six months after the trial LPLV for trials with pediatric participants regardless of approval status.
In countries outside the US and the EU, Kite adheres to all mandatory results posting requirements in accordance with the country-specific guidelines for that region.
Gilead, the parent company of Kite, is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) & the European Federation of Pharmaceutical Industries and Associations (efpia) and prioritizes transparency initiatives to align with the PhRMA Principles for Responsible Clinical Trial Data Sharing.
Sharing of clinical trial data
Kite is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Kite shares anonymized Individual Patient Data (IPD) upon request or as required by law and/or regulation.
For studies of newly approved compounds or indications the IPD will be available for request six months after FDA and EMA approval. Such requests are at the discretion of Kite and dependent on the nature of the request, the merit of the research proposal, availability of the data and the intended use of the data. If Kite agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality prior to the release of any data.
If you would like additional information or would like to request access to Kite clinical trial data for research purposes, please contact us at 1-844-454-KITE (1-844-454-5483) or visit kitemedinfo.com
Understands that quality provides our patients with confidence in the safety and effectiveness of our life-saving medicines. Quality plays an integral role in the foundation of our culture and upholds our work in research, development, manufacturing, and in the delivery of our innovative therapeutics.
Our quality pledge to patients and their families is both personal and embedded throughout our organization. We focus on what matters most to them in what we do and how we do it. At Kite:
- We are committed to bringing safe, effective medicines to our patients.
- We protect the health and safety of our patients by relying on scientific knowledge and data to identify, manage, and control risks.
- We comply with regulatory requirements to ensure the quality and safety of our products from inception to delivery.
- We scrutinize our data for accuracy, constancy, and reliability to ensure its integrity.
- We uphold excellence of our quality systems and processes and drive for continuous improvement.
We believe that quality not only builds patient trust, but is imperative to our vision of pursuing a cure through cell therapy.