アステラスでは、臨床試験における多様性が医療の進歩にとって、また、すべての人が医療の革新のベネフィットを受けられるようにするために不可欠だと考えています。We are committed to fostering an inclusive environment that reflects the diverse communities we serve.

To do this, we are committed to:

1

Engage Diverse Populations

Actively seek to include people from different racial, ethnic, gender, age and socioeconomic backgrounds in our clinical trials to make sure the results apply to all

2

Implement Inclusive Practices

Design our clinical trials to be accessible, culturally sensitive, and supportive to make participation easier

3

Work with Communities

Partner with community groups, healthcare providers and patient advocacy organizations to raise awareness about clinical trials, address barriers to participation, and build trust with patients and caregivers

4

Educate and Train Staff

Train our teams on the importance of diversity and equip them with the tools to engage and include everyone effectively

5

Advocate for Change

Join industry-wide efforts to remove barriers and make it easier to take part in clinical trials

By committing to these principles, we aim to enhance the quality and relevance of our clinical research, ultimately leading to better health outcomes for everyone.

臨床試験において多様性が重要な理由

People bringing their hands together

Looking back through the history of clinical research, women, people of different racial and ethnic groups, and older adults were underrepresented. Sometimes, these groups were left out completely.

However, diseases, health conditions and treatments affect patient populations differently. For example:

1

Gastric (stomach) cancer occurs more often in Black, Asian and Latino populations than in Caucasians (white people)

2

Prostate cancer, the most common cancer in men, affects more Black men than those of any other racial or ethnic group.

3

Sjögren’s Syndrome is more common in women than in men

4

An older patient’s body may process medications differently than a younger patient’s body

Today, researchers know that it is important to include diverse groups of people in clinical trials. This includes different genders, races, ethnicities, and age groups. This inclusive approach helps researchers understand how diseases affect different people and how they respond to treatment.

To develop treatments that are safe and effective for everyone, diversity must be a priority in clinical trials.

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夫婦に話をする医師

参加の妨げになっているものが何かを把握する

かつて、世界各地では、臨床研究で不正行為や人権侵害が起こったことがありました。こうした出来事をきっかけに、臨床試験に参加する人々を守るための新しい法律や倫理指針がつくられました。現在では、臨床試験の参加者に対する倫理的な扱いを保証するための保護制度が整備されています。しかし、未だに、臨床研究自体や臨床試験に参加することについて懸念がある方が多いのも事実です。最近の研究では、これまで試験の対象とならなかった地域社会の方々も臨床試験への参加に意欲があることわかっていますが、多くの場合、これらの方々には、必要な情報が届いていなかったり、参加の機会が十分に与えられていません。

Additional efforts to improve diversity in clinical trials

There are other important measures being taken to increase diversity and ensure scientifically representative clinical research. These include:

1

1990

2

Mid 1990s

National Institutes of Health (NIH) requirement that clinical trials include racial and ethnic minorities, women and individuals of all ages

3

Mid 2010-2020 to Present

Study sponsors voluntarily providing data to help the FDA track the participation rates of females, males, children, the elderly, and different underrepresented groups

4

Est 2021

United Kingdom’s NHS Race and Health Observatory initiative that investigates and addresses race inequality in medicine

5

Early 2000s to Present

Food and Drug Administration (FDA) regulations and guidance to ensure diverse inclusion in clinical trials

6

2020 to Present

Industry-wide initiatives, such as PhRMA’s Equity Initiative in the United States

7

Present Time

Additional Resources

1

Resource

Learn more about PhRMA’s industry initiatives to enhance diversity in clinical trials

2

Resource

Learn more about diversity in a clinical trials topics from the Center for Information and Study on Clinical Research Participation (CISCRP).

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詳細

Kid visiting a doctor
1

What are Clinical Trials?

People holding hands and standing in a circle
2

臨床試験が重要である理由

Doctor comforting elderly lady
3

臨床試験に参加する理由