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    新聞動態
     市場占比小于海外藥 我國迫切需要加強新藥研發

      【中國制藥網 市場分析】目前我國是世界第二大醫藥消費國,幾年后就會成為第一大醫藥消費國。但是,“市場上99%的新藥都是國外研發的,為此我們要承受高昂的價格。” 所以,我國加強新藥研發非常迫切,也正因為如此,國家把生物制藥列為重要發展戰略。

      在新藥研發過程中,需要大量患者參加臨床試驗,用以證明藥物的安全性和有效性。盡管我國是人口大國,但是在新藥臨床試驗中,我國受試者占比卻很小,對上市新藥作出最大貢獻的是歐美國家的受試者。我國加強新藥研發非常迫切,也正因為如此,國家把生物制藥列為重要發展戰略。

      日前,在北京中華世紀壇舉辦的“慈善北京宣傳周”活動中,“臨床研究促進公益基金”(以下簡稱公益基金)的成立吸引了很多關注的目光。作為癌癥患者,北京抗癌樂園園長孫桂蘭在公益基金成立大會上表示,新藥研制對人類健康是必不可少的事情。患者是新藥臨床研究的主要對象和最終受益者,但一直以來我國患者對臨床研究的價值和意義知之甚少。

      公眾偏見,臨床研究軟肋

      我國藥物臨床研究自上世紀90年代才逐步開展起來,近幾年發展迅速,到2016年底,已有2萬余項臨床試驗在同步進行。業內人士認為,中國新藥臨床試驗是在全球同行的帶動下逐步發展起來的,這些發展主要體現在醫學和制藥領域,但是整個社會對于新藥的研發、醫學探索的認知并沒有明顯進步,公眾的觀念沒有得到很好的引導,的、正面的宣傳非常欠缺,不實的、負面的謠言卻很容易流傳,導致整個社會對新藥臨床試驗缺乏科學認知。

      眾所周知,在新藥研發過程中,需要大量患者參加臨床試驗,用以證明藥物的安全性和有效性。盡管我國是人口大國,但是在新藥臨床試驗中,我國受試者占比卻很小,對上市新藥作出最大貢獻的是歐美國家的受試者。

      近些年我國患者對于臨床研究的認識已經有了很大提高,但與發達國家相比還有很大差距。北京大學第三醫院藥物臨床試驗機構主任、心內科李海燕教授公布了一項在中、美、印、韓4國對公眾臨床研究認知的調查結果,該項目在北京市8個區域調查了400多人。調查結果顯示,在對臨床研究的認知度方面,北京的認知度與美、印等國差別不大,但信任度大約只有別國的一半;利他主義(即進行臨床研究是為了社會、為了他人)方面,中國最低,只有22%,而印度為65%,美國為51%。結果值得國人深思。

      醫學進步,不能只靠醫生

      目前我國是世界第二大醫藥消費國,幾年后就會成為第一大醫藥消費國。但是,“市場上99%的新藥都是國外研發的,為此我們要承受高昂的價格。” 所以,我國加強新藥研發非常迫切,也正因為如此,國家把生物制藥列為重要發展戰略。

      在臨床研究中,受試者本身是一個非常重要的環節。受試者的參與、信任和理解,對于獲得高質量的臨床數據非常關鍵。“公益基金應該進行一些通俗易懂的公眾教育,引導人們正確認識臨床研究,通過各方努力做好受試者教育。”

      對于人們對參與臨床試驗的顧慮,李樹婷表示,新藥臨床試驗在我國經過20多年的發展有了很大進步,現在知情同意和倫理方面的審查都非常嚴格。“參與臨床試驗并不可怕,這是一件對自己、對他人都有利的事情。”她說。

      據了解,為了改善臨床研究的現有環境,公益基金將開展線上、線下宣傳教育,宣講臨床研究相關知識、分享經驗;以藥企發起的新藥研發項目為課題,開展患者招募、疾病知識傳播、用藥指導等;建立受試者保護辦公室,接受受試者咨詢和投訴,協助解決受試者的問題和困難,提供倫理方面的救助等。

      “新藥研發不僅需要患者參與臨床試驗,而且需要患者主動配合,積極提供自己的數據,這對保證臨床試驗的質量非常重要。臨床研究更講究對科學的奉獻精神。”曹曉春希望,更多業內人士,包括藥廠、CRO、研究者等各方人士都能參與進來,大家共同努力,改善公眾對臨床研究的認識,讓更多的人參與或支持臨床研究的良性發展。

        原標題:中國新藥研制發展如何? 還差這一步!

      

    (來源:中國醫藥報)

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