Beyond Celiac Coalition and FDA Discuss Major Patient Barriers to Accelerate Clinical Trials for Celiac Disease
Beyond Celiac Coalition and FDA Discuss Major Patient Barriers to Accelerate Clinical Trials for Celiac Disease
PHILADELPHIA, July 2, 2024 /PRNewswire/ -- The Beyond Celiac Coalition, a precompetitive partnership of multidisciplinary stakeholders involved in the development of potential treatments for celiac disease, met recently with the FDA to discuss a collaborative approach to making therapeutic trials for celiac disease more patient-centric while maintaining scientific rigor.
繼續推進治療乳糜瀉的潛在治療方案的開發，多學科利益相關者的預競爭夥伴關係Beyond Celiac聯盟最近與FDA會面，討論合作方式，使治療乳糜瀉的臨床試驗更加以病人爲中心，同時保持科學的嚴謹性。
Participating in clinical trials is necessary to accelerate research for treatment breakthroughs and a cure. Yet clinical trials for celiac disease often struggle because currently most studies require participants to undergo procedures or activities deemed too invasive or debilitating by many patients.
參加臨床試驗對於加快治療突破和治癒研究是必要的。但乳糜瀉的臨床試驗經常面臨困境，因爲當前大多數研究需要參與者接受被許多患者認爲過於侵入性或有害的程序或活動。
"This was a pivotal meeting because key stakeholders heard directly from people living with celiac disease about how the disease and the gluten-free diet affect their quality of life," Alice Bast, Founder and CEO of Beyond Celiac, says.
Beyond Celiac的創始人兼首席執行官Alice Bast表示：“這是一次關鍵的會議，因爲關鍵利益相關者直接聽取了患有乳糜瀉的人關於該疾病和無麩質飲食如何影響他們的生活質量的意見。”
Another key discussion point was about the use of gluten in clinical trials. "It will be difficult to get a drug approved without introducing patients to gluten in clinical trials. However, we recognize that this is a burden for clinical trial participants. There is no one right way to use gluten in clinical trials. It was educational for everyone to hear many perspectives on this topic," said Debra Silberg, MD, PhD, Chief Scientific Officer at Beyond Celiac.
另一個關鍵討論點是臨床試驗中使用的麩質。Beyond Celiac的首席科學官Debra Silberg表示：“沒有在臨床試驗中介紹患者接觸麩質就很難獲得批准。但是，我們認識到這對於臨床試驗參與者來說是一種負擔。沒有一種正確使用麩質的方法。許多人對這個話題有許多看法，這是一個有教育意義的經歷。”
This was the first time the Beyond Celiac Coalition convened all stakeholders including patients to meet with FDA representatives to discuss the seriousness of celiac disease and the goals for therapies. The purpose of the Beyond Celiac Coalition is to bring together members from the pharmaceutical and biotech industry; academic researchers and clinicians; and gastrointestinal professional societies to identify and address significant barriers to developing treatments for celiac disease.
Beyond Celiac聯盟首次召集所有利益相關者，包括患者與FDA代表，討論乳糜瀉的嚴重性和治療目標。Beyond Celiac聯盟的目的是聚集製藥和生物技術行業的成員、學術研究人員和臨床醫生，以及胃腸專業社團，共同解決開發乳糜瀉治療方法的重要障礙。
Beyond Celiac Coalition patient organization and professional society members include the American Gastroenterological Association, Beyond Celiac and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Academic and clinician members include Robert P. Anderson, MD; Lisa Fahey, MD; Edwin Liu, MD; Joseph A. Murray, MD; Marie Robert, MD; Jocelyn Silvester, MD, PhD; Marisa Stahl, MD, and Adam C. Stein, MD. The industry members are Anokion, Chugai Pharmaceutical Co, Sanofi, Takeda Pharmaceuticals and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.
Beyond Celiac聯盟的患者組織和專業社團成員包括美國胃腸學會、Beyond Celiac和北美兒科胃腸病、肝病和營養學會（NASPGHAN）。學術和臨床醫生成員包括Robert P. Anderson，MD； Lisa Fahey，MD； Edwin Liu，MD； Joseph A. Murray，MD； Marie Robert，MD； Jocelyn Silvester，MD，PhD； Marisa Stahl，MD和Adam C. Stein，MD。業界成員是Anokion，千葉製藥，賽諾菲，武田製藥和梯瓦製藥，梯瓦製藥產業公司的美國分支機構。
Although celiac disease is a common disease with a significant unmet need, there is no medical treatment or cure. Following a strict gluten-free diet is the only way the 3.2 million Americans with celiac disease can control it. However, many people get inadvertent exposure to gluten even if they are very careful. "If more Americans understood how dangerous gluten can be for a person with celiac disease, it would be a big step forward for those with celiac disease to be able to eat without fear of unknowingly eating gluten," Bast adds.
儘管乳糜瀉是一種常見的疾病，也存在着重大的未滿足需求，但目前沒有醫療治療或療法。嚴格無麩質飲食是320萬乳糜瀉患者控制乳糜瀉的唯一方法。然而，即使非常小心，許多人也會無意中接觸到麩質。“如果更多的美國人了解麩質對患有乳糜瀉的人有多麼危險，那麼對於那些能夠無畏食用的乳糜瀉患者來說，這將是一個重要的步驟，”Bast補充道。
About Beyond Celiac
Founded in 2003, Beyond Celiac is the leading catalyst for a celiac disease cure in the United States, serving as a patient advocacy and research-driven organization working to drive diagnosis and accelerate the discovery of new treatments. By engaging with the top scientists in the field, making the right investments in research and supporting the broad community of those with celiac disease and gluten sensitivity, Beyond Celiac envisions a world in which people can live healthy lives and eat without fear – a world Beyond Celiac. BeyondCeliac.org
關於Beyond Celiac
成立於2003年的Beyond Celiac是美國治療乳糜瀉的領先催化劑，是一家以病人爲中心、以研究爲驅動的機構，致力於推動診斷並加速新療法的發現。通過與該領域的頂尖科學家接觸、在研究方面進行正確的投資以及支持患有乳糜瀉和對麩質敏感的廣泛社區，Beyond Celiac展望着一個世界，人們可以健康地生活和無畏地飲食——一個超越乳糜瀉之外的世界。BeyondCeliac.org
Media Contact:
Juliann Kaiser, 770.643.1807
[email protected]
媒體聯繫人：
Juliann Kaiser，770.643.1807
[email protected]
Angela Crist, 419.306.4770
[email protected]
Angela Crist，419.306.4770
[email protected]
SOURCE Beyond Celiac
資料來源：Beyond Celiac
譯文內容由第三人軟體翻譯。