Respect for Human Rights, Protection of the Privacy and Confidentiality of the Personal Information of Clinical Trial Subjects, and Assurance of Reliability in Clinical Trials

Astellas conducts clinical trials to assess the efficacy and safety of new drug candidates in patients under the Declaration of Helsinki, Good Clinical Practice (GCP), and applicable laws and regulations with full consideration to protecting human rights and the privacy and confidentiality of clinical trial subjects’ personal information. Clinical study protocols developed by Astellas are evaluated and approved for ethical acceptability and scientific validity by internal and external evaluation committees.

In conducting clinical trials, Astellas confirms that clinical trial subjects have provided informed consent, having received a full explanation of the purpose and methods of the trial, its expected benefits and disadvantages, matters related to compensation for health impairment and other details. Moreover, we regularly implement education and training for employees and staff members involved in clinical trials, and monitor medical institutions that perform clinical trials to ensure full GCP compliance.

In addition, we protect the privacy and confidentiality of the personal information of clinical trial subjects by managing trial data appropriately. Periodic assessments are also made to check that any outsourced clinical trials are conducted in accordance with the same standards.

Disclosure of information on clinical trials and trial results

Astellas is committed to increasing transparency and providing disclosure of clinical trial data. Maximizing the value of clinical trial data, and putting it to good use in driving scientific advancement and increasing innovation, requires that the clinical trial data be appropriately accessible to the research community and others who might utilize it. The Policy on Disclosure of Clinical Trial Data*1 has been published on the Company website to present Astellas’ position on this matter.

Astellas registers clinical trials, posts clinical trial information, and discloses clinical trial results. Astellas provides patient-level data that have been anonymized in accordance with applicable laws and regulations through an external website*2 to those scientists and healthcare professionals requesting it in the case that review panel consisting of third party experts evaluates and approves the request based on scientific usefulness and scientist eligibility. In addition to disclosing summaries of clinical trial findings from phase 1-4 interventional studies after the approval or discontinuation of the study so that healthcare professionals and the public can confirm them via the clinical trial results website(s), these website(s) also give patients access to plain language summaries of study results prepared for non-experts*3.

*1 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-data#r_and_d
*2 Patient-level data are provided through the following website:
http://www.clinicalstudydatarequest.com
*3 Results of the clinical trials are provided through the following website:
www.clinicaltrials.astellas.com and/or www.trialsummaries.com/Home/LandingPage

Expanded access to investigational medicines

Astellas has set forth its approach to supplying investigational medicines to patients for purposes other than clinical studies in its Position on Expanded Access to Investigational Medicines*4.

Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines. In these cases, in response to a request for investigational medicines from a primary physician, Astellas fairly, impartially and rapidly evaluates whether or not the patient meets the required conditions to provide early access as appropriate.  Furthermore, early access programs may be established in countries where the clinical development of an investigational medicine is progressing and the medicine is targeted for commercial availability. This procedure will be implemented in accordance with the regulations of the country where early access is requested. Information on early access programs can be found on the corporate website*5.

*4 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-medicines#access_to_health
*5 For details, please visit the following website:
https://www.astellas.com/system/files/active_expanded_access_programs_en_20211029.pdf

Patient centricity in clinical drug development

The pharmaceutical industry is actively working on patient centricity in clinical drug development and is discussing it at all points in pharmaceutical development.

We are listening to the opinions of patients, their families and caregivers by working with patient organizations.

For example, to improve our communication and education tools, we obtained feedback from members of patient organizations on our informed consent, pediatric assents, thank you letters to study participants, and the design of our website for patients.

In addition, to understand the patient experience in a clinical trial, one study team is currently obtaining feedback from parents of children in a pediatric trial using a questionnaire.

Through these efforts, we try to make it easier for patients to participate in clinical trials so that we can obtain trial results with scientific significance for patients.

Anti-doping measures

Doping is an issue closely related to abuse and misuse of medicines in sports. It is a serious priority for the pharmaceutical industry given that it is not only associated with a risk of inducing serious side effects, but it can also become a breeding ground for the unauthorized distribution and counterfeiting of medicines. Astellas is working to identify the compounds under development that have the potential to be used in doping and to prevent the misuse of those compounds.

In October 2016, Astellas made a global agreement with the World Anti-Doping Agency (WADA) to partner on the prevention of misuse and abuse of medicines for doping in sports which aims to contribute to the eradication of doping and improvement of public health.

Doping in sports relies primarily on the misuse and abuse of commercially available medicines, as well as compounds in development that are not as well-known or easily detected. To support WADA in its efforts to address this issue, Astellas identifies compounds solely developed by Astellas or its affiliates with the potential for sport-related doping abuse and cooperates in sharing relevant information to aid WADA in the organization’s development of detection methods for these compounds. Additionally, Astellas cooperates with WADA to minimize the risk of misuse of compounds with doping potential during clinical trials to avoid opportunities for abuse.