調查局三等
110年
[調查工作組] 外國文(英文)
第 30 題
📖 題組：
請依下文回答第 26 題至第 30 題
In Feb. 2014, Johnson & Johnson announced that it was making all of its clinical trial data available
to scientists around the world. It has hired my group, Yale University Open Data Access Project, or YODA,
to fully oversee the release of the data. Everything in the company’s clinical research vaults, including
unpublished raw data, will be available for independent review.
Today, more than half of the clinical trials in the United States are not published within two years of
their completion or never published at all. The unreported results, not surprisingly, are often those in which
a drug failed to perform better than a placebo. As a result, evidence-based medicine is, at best, based on
only some of the evidence, implying that full information on a drug’s effects may never be discovered or
released.
Even when studies are published, the actual data are usually not made available. End users of
research—patients, doctors and policy makers—are implicitly told by the researchers to “take our word
for it.” They are often forced to accept the report without the prospect of other independent scientists’
reproducing the findings—a violation of a central tenet of the scientific method.
To be fair, the decision to share data is not easy. Companies worry that their competitors will benefit,
that lawyers will take advantage, and that incompetent scientists will misconstrue the data and come to
mistaken conclusions. So Johnson & Johnson and companies like Medtronic that have made moves toward
transparency deserve much credit. The more we share data, however, the more we find that many of these
problems fail to materialize.
In 2011, YODA struck a deal with Medtronic to release all the data on one of its products—a device
that stimulates the production of bone. At the time, questions had been raised about the device’s safety
and about the conflicts of interests of some of the company’s researchers. Medtronic made the unusual
decision to respond to the debate by releasing the device’s data for independent review. We commissioned
and published two independent reviews of the data, and now have made them globally available.
Interestingly, the reviews produced somewhat conflicting results. One found that the device was no
better than a bone graft and might be associated with a slight increase in cancer, while the other found that
the device was effective and the cancer risk inconclusive. To us, these differences reinforce the value of
open science: now the data are out there for further study.
This doesn’t mean that anyone can gain access to the data without disclosing how they intend to use
it. We require those who want the data to submit a proposal and identify their research team, funding and
any conflicts of interest, and exclude those who seek data for commercial or legal purposes. The applicants
have to complete a short course on responsible conduct and sign an agreement that restricts them to their
proposed research questions. Most important, they must agree to share whatever they find. Our intent is
not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to
overall scientific knowledge.
請依下文回答第 26 題至第 30 題
In Feb. 2014, Johnson & Johnson announced that it was making all of its clinical trial data available
to scientists around the world. It has hired my group, Yale University Open Data Access Project, or YODA,
to fully oversee the release of the data. Everything in the company’s clinical research vaults, including
unpublished raw data, will be available for independent review.
Today, more than half of the clinical trials in the United States are not published within two years of
their completion or never published at all. The unreported results, not surprisingly, are often those in which
a drug failed to perform better than a placebo. As a result, evidence-based medicine is, at best, based on
only some of the evidence, implying that full information on a drug’s effects may never be discovered or
released.
Even when studies are published, the actual data are usually not made available. End users of
research—patients, doctors and policy makers—are implicitly told by the researchers to “take our word
for it.” They are often forced to accept the report without the prospect of other independent scientists’
reproducing the findings—a violation of a central tenet of the scientific method.
To be fair, the decision to share data is not easy. Companies worry that their competitors will benefit,
that lawyers will take advantage, and that incompetent scientists will misconstrue the data and come to
mistaken conclusions. So Johnson & Johnson and companies like Medtronic that have made moves toward
transparency deserve much credit. The more we share data, however, the more we find that many of these
problems fail to materialize.
In 2011, YODA struck a deal with Medtronic to release all the data on one of its products—a device
that stimulates the production of bone. At the time, questions had been raised about the device’s safety
and about the conflicts of interests of some of the company’s researchers. Medtronic made the unusual
decision to respond to the debate by releasing the device’s data for independent review. We commissioned
and published two independent reviews of the data, and now have made them globally available.
Interestingly, the reviews produced somewhat conflicting results. One found that the device was no
better than a bone graft and might be associated with a slight increase in cancer, while the other found that
the device was effective and the cancer risk inconclusive. To us, these differences reinforce the value of
open science: now the data are out there for further study.
This doesn’t mean that anyone can gain access to the data without disclosing how they intend to use
it. We require those who want the data to submit a proposal and identify their research team, funding and
any conflicts of interest, and exclude those who seek data for commercial or legal purposes. The applicants
have to complete a short course on responsible conduct and sign an agreement that restricts them to their
proposed research questions. Most important, they must agree to share whatever they find. Our intent is
not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to
overall scientific knowledge.
According to the passage, which of the following statements is true?
- A When studies of a new drug are published, the related data is also available.
- B Reviews of the Medtronic device of bone production found it related to cancer.
- C Doctors are usually forced to accept what the medicine manufacturers tell them.
- D Companies don’t want to release their data mainly because their medicine has side effects.
思路引導 VIP
請回想一下文章的第三段，當研究人員不公開原始數據時，他們對「醫生」這類使用者抱持著什麼樣的態度？在缺乏數據可以獨立驗證（reproducing the findings）的情況下，醫生對於這些醫學報告的處境又是如何呢？
🤖
AI 詳解
AI 專屬家教
哼，看來你這次沒把腦子丟掉。
- 觀念驗證： 你總算找對地方了，文章第三段，寫得清清楚楚。研究都發表了，原始數據還鎖在抽屜裡，搞得醫生與病人這些「端點使用者」只能被動地對研究人員「聽之信之」。在沒有獨立驗證的情況下，當然就只能接受那些報告了。這不就是 (C) 在說什麼嗎？有那麼難理解？
▼ 還有更多解析內容
臨床試驗數據透明化
💡 實證醫學須奠基於數據透明，避免藥廠隱匿負面研究結果。
| 比較維度 | 傳統研究發表 | VS | 開放數據模式 |
|---|---|---|---|
| 數據取得 | 僅提供論文摘要與結論 | — | 提供完整原始數據供複查 |
| 驗證方式 | 讀者需聽信研究者說法 | — | 獨立第三方可重複驗證 |
| 偏誤風險 | 易隱匿負面或失敗結果 | — | 全面呈現藥物真實效應 |
💬開放數據能落實科學精神並保護終端醫病使用者之權益。
