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English to Turkish: Overall Summary of XXX Clinical Program General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English The xxx clinical development program for the treatment of patients with advanced malignances involving bone to prevent SREs is supported by 3 pivotal, international, phase 3, randomized, double blind, active controlled studies designed to determine if xxx is noninferior (primary endpoint) or superior (secondary endpoint, tested only after noninferiority was demonstrated) to zoledronic acid (Zometa®) with respect to preventing or delaying the first on-study occurrence of an SRE and whether xxx was superior to zoledronic acid in delaying the time to first and subsequent on-study SRE in either adults with advanced breast cancer and bone metastases (Study 20050136); adults with other solid tumors (excluding breast and prostate cancer) and bone metastases or multiple myeloma (Study 20050244), or men with hormone refractory (castrate-resistant) prostate cancer and bone metastases (Study 20050103). While these studies enrolled populations with different tumor types, they were consistent in terms of study design, endpoints, and statistical methodology. Zoledronic acid was chosen as the active comparator because it is the most potent bisphosphonate (Gutta and Louis, 2007) broadly licensed for use across the cancer types evaluated in these studies (Table 1) and is generally the most frequently prescribed IV bisphosphonate in patients with advanced cancer.
These studies were similar in terms of endpoint definitions (ie, reduction or prevention of the occurrence of SREs; the composite endpoint of SREs was the same in both the xxx and zoledronic acid registrational studies), statistical methods, subject population, and dose and administration of zoledronic acid to the zoledronic acid registrational studies in advanced cancer, as discussed in Section 4.1.
Translation - Turkish Kemikte metastaz yapan ilerlemiş maligniteli hastaların tedavisinde SRE’lerin önlenmesi için xxx klinik geliştirme programı, çalışmada ilk SRE gelişiminin önlenmesi veya geciktirilmesi açısından xx'in zoledronik aside (yyy®) eşdeğer olup olmadığı (primer sonlanma noktası) veya zoledronik asitten üstün olup olmadığının (sekonder sonlanma noktası, sadece eşdeğerlik gösterildikten sonra test edilmiştir) belirlenmesi ve xx'in, ilerlemiş meme kanseri ve kemik metastazı bulunan erişkinlerde (Çalışma 20050136), diğer solid tümörler (meme ve prostat kanseri hariç) ve kemik metastazı veya multipl myelom bulunan erişkinlerde (Çalışma 20050244) veya hormona dirençli (kastrasyona dirençli) prostat kanseri ve kemik metastazı bulunan erkeklerde (Çalışma 20050103), çalışmada ilk ve sonraki SRE meydana gelene kadar geçen sürenin geciktirilmesi açısından zoledronik asitten üstün olup olmadığının belirlenmesi amacıyla tasarlanan 3 öncü, uluslararası, faz 3, randomize, çift kör, aktif kontrollü çalışma ile desteklenmiştir. Bu çalışmalar, farklı tümör tipleri olan popülasyonların dahil edilmesine karşın çalışma tasarımı, sonlanma noktaları ve istatistik metodoloji açısından uyumluydu. Zoledronik asit bu çalışmalarda değerlendirilen kanser tiplerinde büyük ölçüde ruhsatlandırılmış, en potent bifosfonat (Gutta ve Louis, 2007) (Tablo 1) ve genelde ilerlemiş kanseri hastalarda en yaygın reçete dilen IV bifosfonat olması nedeniyle aktif karşılaştırma ilacı olarak seçilmiştir.
Bu çalışmalar sonlanma noktaları (yani, SRE’lerin önlenmesi veya insidansının azaltılması, SRE’lerin birleşik sonlanma noktası xxx ve zoledronik asit ruhsatlandırma çalışmalarında aynıydı), istatistiksel metotlar, hasta popülasyonu açısından Bölüm 4.1’de ele alındığı gibi ilerlemiş kanserde yapılan zoledronik asit ruhsatlandırma çalışmalarındaki zoledronik asit doz ve uygulama şeklinde benzerdi.
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Translation education
Bachelor's degree - Cumhuriyet University
Experience
Years of experience: 18. Registered at ProZ.com: Feb 2005.
* 16 years full-time experience in Turkish medical translation,
* Specializing only on medical & pharmaceutical & medical device projects,
* Long-term and successful collaboration with more than 45 clients based in USA, UK, Spain, Germany, France, Sweden, Switzerland, Netherlands, Japan, Australia and Turkey.
Recent projects mainly include: *Clinical / Non-Clinical Reviews,
*Informed Subject Consent Forms (ICFS) & Subject Information Sheets,
*Subject e-Diary/Visit Reminders,
*Study Reports, Development Safety Update Reports (DSURs), Pharmacovigilance Reports,
*Adverse Event Reaction Reports,
*Common Technical Documents (CTDs),
*Overall Quality Reviews,
*Marketing Authorization Documents,
*Summary of Drug Products (SPCs), Patient Information Leaflets (PILs),
*New Drug Applications,
*Instruction for Use (IFUs) for Medical Devices,
*Medical Device Manual & Training & Information Forms,
*Clinical Trial Protocols, Clinical Trial Synopsis, Protocol Amendments, Summary of Changes,
*Clinical Trial Agreements (CTAs), *SSCP (Summary of Safety and Clinical performance.
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