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如何撰寫國衛院之研究計劃

如何撰寫國衛院之研究計劃. 吳明蒼 , MD, ScD 分機 : 2315 or 2340 E-mail: mingtsangwu@yahoo.com. 高雄醫學大學. 多年期計畫. Brain neoplasm, leukemia, and petrochemical exposures (US NIH for 5 years) Be turned down 3 times The association of areca nut usage and esophageal cancer (NHRI ( 院內處 ) for 3 years ( 三個子計畫 ) )

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如何撰寫國衛院之研究計劃

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  1. 如何撰寫國衛院之研究計劃 吳明蒼, MD, ScD 分機: 2315 or 2340 E-mail: mingtsangwu@yahoo.com

  2. 高雄醫學大學

  3. 多年期計畫 • Brain neoplasm, leukemia, and petrochemical exposures (US NIH for 5 years) • Be turned down 3 times • The association of areca nut usageand esophageal cancer (NHRI (院內處) for 3 years (三個子計畫)) • 衛生署不定期之重點研究計畫 • 食道癌的分子流行病學與分子生物學之研究 (台大 李章銘 ) • The molecular epidemiology of cervical neoplasm (NHRI (院外處) for 5 years) • 整合性醫藥衛生科技研究計畫http://www.nhri.gov.tw/nhri_org/ex/mainhr.htm (院外研究業務處)

  4. 成功率: 20-30%

  5. 目標 一、以整合性之醫藥衛生科技研究，解決國人重要健康問題。 二、支援國內醫藥衛生研究機構，發展具特色之研究，提昇我國醫藥衛生研究水準。

  6. 計畫型態 一、群體計畫 ( Program Project Grant ) • 強調科際整合（如基礎及臨床之合作研究） 。 二、 創新研究計畫 ( Innovative Research Grant ) • 創新研究計畫乃為鼓勵符合研究重點之研究，計畫主持人應具獨立研究能力，且其研究內容對國民健康有重要性。 三、研究發展獎助計畫 ( Career Development Grant ) • 鼓勵新進研究人員。

  7. 研究重點 • 申請計畫之研究主題應著重於利用最新的科學技術，以深入研究國人重要疾病的成因、診斷、治療、預防、康復；或藉由醫療保健及衛生政策、制度之研究，以解決相關醫藥衛生問題 一、癌症基礎與臨床研究 二、分子與基因醫學研究 三、臨床研究 四、生物技術與藥物研究 五、 生物統計與生物資訊研究 六、 醫療保健政策研究 七、環境衛生與職業醫學研究 八、 醫學工程研究 九、 老年醫學研究 十、 精神醫學與藥物濫用研究 十一、 疫苗研究  十二、 幹細胞研究 十三、 奈米醫學研究 十四、 其他重要疾病或醫藥衛生問題研究

  8. 申請重要事項 • 計畫申請期程：視研究內容之實際需要，群體計畫及創新研究計畫之申請期程最短不得少於三年，最長則不得超過五年 • 計畫申請經費：1.每一計畫申請經費之限制，群體計畫每年最高上限為新台幣一千萬元，創新研究計畫每年最高上限為三百萬元，研究發展獎助計畫則以全程計畫總經費不超過八百萬元為限。 • 計畫申請截止日期： • 申請意願書截止期限為九十三年三月十日下午五時正 • 計畫申請書截止期限為九十三年三月二十四日下午五時正 • 人體試驗審查同意函或動物實驗審查同意函-五月卅一日下午五時正前

  9. 審查作業 • 審查作業程序乃國內目前公認最為嚴謹、公正、公開 • 由國家衛生研究院聘請國內外傑出醫藥衛生學者專家，組成學術評議會。 • 學術評議會下依計畫主題分設五組學術審查會，每一學術審查會由國家衛生研究院依當年度各組計畫數多寡，聘請國內外相關領域之學者專家八至十五人組成。 • 各組學術審查會之召集人，按審查委員之專長，每一計畫指定兩位審查委員，負責撰寫審查意見書，並由該兩位審查委員及另一位研究領域相近之評分委員進行初審評分。

  10. 計畫書內容 • Abstract • (A)Specific Aims • Clear & concise • (B) Statement of Qualifications for Innovative Research Grant Award • PI’s research qualification • (C) Background and Significance • Why important? Novel? Feasible? • (D)Previous and Current Studies (Preliminary Results) • (E)Research Design and Methods • Research teams (Co-investigators or supporting staffs) can perform this project, Lab. QA/QC • Sample size and statistical power • (F) Anticipated Results

  11. Science:非懸疑小說, 或官話 Hit the point Western style 廢話少說 有話直說 開門見山 Eastern style 拐彎抹角 話中有話 柳暗花明又一村 *English is not our native language. *Use words: precise, simple, necessary

  12. 創新型摘要-Molecular epidemiology of cervicalneoplasm • 此疾病或健康在醫藥上之重要性…… 目前資料仍缺乏或不一致……而我們的pilot study 初步發現…….因此本計畫欲探討??與??之關係 • Cervical cancer (23.8 per 100,000 females) was the most prevalent malignancy found among Taiwanese women in the year2,000 and it was sixth leading cause of cancer deaths among women in Taiwan. Although the presence of human papillomaviruses, particularly type 16 and 18, is the major risk factor for the development of cervical neoplasm, environmental factors, for example cigarette smoking, may also be involved in cervical carcinogenesis. However, while the percentage of heavy smokers among Taiwanese women, compared to that among Caucasian women (28%), is relatively low (3-4%). In a recent study of 100 cases with cervical intraepithelium neoplasms (CIN2) and 197 controls in Chia-Yi City, we found that women who were exposed to environmental tobacco smoke (ETS) had a 3.53-fold (95% confidence interval (CI) = 1.90-6.57)risk of developing cervical neoplasm than those who were not. In addition, we found that women who cooked in the kitchen without the presence of a fume extractor between the ages of 20 and 40 had 2.29 times higher risk (95% CI = 1.08-4.87) of developing cervical neoplasm. These findings suggest, besides cigarette smoking, other environmental hazards, for example ETS or cooking oil fumes, are also crucial predictors in cervical neoplasm risk. • 簡介研究與實驗設計 • 預期執行計畫完成後之貢獻性及重要性

  13. 整合型摘要-Areca nut usageand esophageal cancer Esophageal cancer is the 11th leading cause of cancer deaths in Taiwan, particularly it is the 6th one in male. In addition to cigarette smoking and alcohol consumption, areca (betel nut) chewing has been reported to play an important role in the development of this cancer in Southeast Asia. Our preliminary results also showed that subjects who chewed more than 20 betel quid per day for 20 years had a 9.2-fold risk of developing esophageal cancer, compared to those who did not among the 104 esophageal squamous-cell carcinoma patients and 277 controls. Therefore, in this project, our theme is to further understand the molecular mechanism of the association between betel nut chewing and esophageal cancer risk. （如何整合）We approach this theme from the perspective of an interdisciplinary team from National Taiwan University Hospital (NTUH), Kaohsiung Medical University Hospital (KMUH), and Kaohsiung Veteran General Hospital (KVGH) that integrates biologic pathogenesis, biomarkers, and molecular epidemiologic studies. This team members include chest surgeons, gastroenterologists, occupational physicians, toxicologists, molecular biologists, and molecular epidemiologists. Our objectives include the following: • 每個子計畫之重點（一句話） Since the scheme of collaborations and interactions has been established in our team and several preliminary findings have been published, we believe that our goals can be achievable.

  14. 計畫書之前言 • Specific aims & study hypotheses: • In this proposed study, we will employ a community-based nested case-control study designed to test the hypotheses that EXPOSURE can be strongly associated with OUTCOME. • Specific Aim 1.To assess the relationship between environmental exposures (cigarette smoking and exposure to ETS) and cervical neoplasm risk. • Hypothesis 1.Cervical neoplasm will be positively associated with cigarette smoking and exposure to ETS after adjusting for other covariates. • Specific Aim 2. • Hypothesis 2.

  15. Research Design and Methods • 研究設計 • 考慮人, 時, 地 • Observational study • Interventional study: animal study, clinical trial • 重要的部分, 需有次標題 • I. Study Population • II. Questionnaire • ……. • 研究方法 • Collect data: • Detail, rationale, & feasibility • Validity & reliability (Laboratory QA/QC) • Statistical analysis • Power calculation & sample size estimation • Use flowchart, figures or tables (易懂)

  16. ~60,000

  17. Statistical Analysis (I) • 與Specific Aims聯貫 • Hypothesis 1: focuses on the environmental risk factors, including cigarette smoking and exposure to ETS:

  18. Sample Size and Statistical Power • We estimate to recruit about 1,000 cases and 1,000 controls during the 5-year study period. Exposure rate in the controlORPowerSample size of cases Cigarette smoking 3.1% 2.0 85% 986 ETS exposures 74.1% 1.5 95% 947

  19. 讓英文老師看過您的proposal

  20. My Experience • You are a salesperson and the peer-reviewers are professional, but very critical, picky and impatient, customers in your business. • How do you persuade them to buy your merchandise?

  21. 虛心受教屢敗屢戰 分機: 2315 or 2340 E-mail: mingtsangwu@yahoo.com

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