如何在中国开展临床试验_二_一个临床研究者的经验分享

开始。一般来讲是按照所谓连续入选的原则进行，即凡是符合标准的患者都应进入入选的程序进行筛选。入选患者一定要严格遵从方案的入选排除标准，过松会增加不符方案的患者进入，过严实际上是增加了新的排除标准，最终变成所谓“超选”。两种情况都

P32

RAS，联合控制心肾损害的靶标

心脏和肾脏各自独立，却又紧密相联。多种危险因素可同时作用于心肾，造成两者联合损害。肾素-血管紧张素系统（RAS）是两器官联系的“纽带”，其激活是心血管疾病发生发展的关键。因此，抑制RAS，是心血管疾病防治的“重头戏”。

ABSTRACT

重点导读

P26

对超说明书用药

多种意义上的完善思考

缺乏医院批准和行政许可的临床试验和实验性临床医疗程序而所采取的“超说明书用药”，本身既不科学，也不合法。“科学性”、“社会性”、“为患者好”必须建立在符合法律程序之上才具有正当性。

P10

如何在中国开展临床试验（二）

临床试验进行中的方案执行尤为重要，关乎整个试验的成功与否。临床试验团队应对方案执行中的每一细节力求按计划进行，如发生方案偏倚或违背时，要及时发现并积极处理，尽可能令方案始终按预定的基线进行。另外，试验进行中首先考虑的是患者的安全性，一切以患者为中心。

P70

浅析临床试验中的偏离或违反方案问题

偏离及违反方案的情况及发生率尽管不可避免，但是要尽一切努力，并采取积极措施，减少

其发生，因为严重

的违反方案会直接影响试验数据的质量，

进而影响试验的结果，甚至左右该新药能否通过政府药政主管机构的核决。

P28

健康中国，掀起“心”革命

——第21届长城国际心脏病学会议报道心血管疾病已成为全世界的“头号杀手”，并仍持续增长，其中大约有一半的病例发生在亚太

地区。而且与西方国家相比，亚洲地区的心血管疾病患者更趋年轻化。因此，对心血管的防治战线必须前移。

P38

ACEI，阻断RAS系统的领跑者

自第一个肾素血管紧张素转化酶抑制剂（ACEI）问世以来，ACEI便以卓越的疗效活跃于降压药物的舞台，拥有大量的循证医学证据，其适应证也在不断扩展。即便在RAS系统抑制剂的其他成员的挑战下，其光环依旧，王者地位尚不可动摇。

P50

氨磷汀在血液系统疾病中的应用

细胞保护剂已成为抗肿瘤药物研究与开发领域的“新星”，氨磷汀就是其中的一名佼佼者，在抗肿瘤、逆转耐药和保护正常细胞方面具有潜在的应用价值，目前已被广泛用于临床多种血液系统疾病。

英文摘要Journal of China Prescription Drug

2010.10VOL.103

Summary

Special Report

Off-label Drug Use, Pros and Cons

from the V iew of Regulation and Science?

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication; off-label use may include irrational use and evidence-based treatments required by the patients’ conditions. The former one is due to the irresponsibility of physicians, and the latter one is needed by the patients’ conditions. Although the latter condition may be supported by clinical evidence, off-label use implicates that both the physicians and patients will face more extra risks. The phenomenon of off-label will continue to exist, how to regulate and avoid the possible risk should be considered the most importantly.

H o w t o R e g u l a t e O f f -l a b e l

D r u g U s e ,a M u l t i -p e r s p e c t i v e Exploration

Without hospital approval and administrative licensing, any off-label use in the name of clinical trial and experimental clinical procedure is neither rational nor legal. Only rationality, sociality, and benefits to the patients that comply with legal proceedings are legitimate.

Column

H o w t o C o n d u c t C l i n i c a l Tr i a l s i n China? (II)

The implementation of clinical trial protocol is particularly important, which is related to whether the whole clinical trial can succeed or not. Clinical trial team should ensure that any detail in the protocol should be implemented according to the plan, if any bias or violation to the original portal occurs, the protocol should be implemented according to the planned baseline as strict as possible. In addition, safety of the participating patients should be the priority to be considered in clinical trial, and patients should be focused as the center.

Insight

Development of Diet Pills Becomes a Hot Potato

Faced with the huge market of diet pills, why some many pharmaceutical manufacturers stay away? Is it due to dif fi culty in drug development, strict drug approval, or lawsuit and huge losses due to post-marketing adverse effects? The paradox is worth pondering!

Conferences

Healthy Heart Revolution in Healthy China

—Report from the 21st Great Wall International Congress of Cardiology (GW-ICC)

Cardiovascular disease has become the world's No. 1 killer, and still growing, with about half of the cases occurred in the Asia Paci fi c region. And compared with the western countries, the patients with cardiovascular diseases in Asia tend to be younger. Therefore, the front for the prevention and treatment of cardiovascular diseases in Asia should be moved forward.

Cardiovascular Disease

RAS:the Target for Combined Control

of Heart and Kidney Impairment

Heart and kidney are independent, but closely linked. Multiple rick factors may act on heart and

kidney simultaneously, causing combined damage to heart and kidney. The renin-angiotensin system (RAS) is a hormone system that regulates blood pressure and fl uid balance, and the activation of RAS is the key of pathogenesis and development of cardiovascular disease. Therefore, inhibition of RAS is the key to the prevention and treatment of cardiovascular disease.

ACEI, the Primary Blocker of RAS

Since the marketing of the first angiotensin-converting enzyme inhibitor (ACEI), ACEIs have been used primarily in treatment of hypertension and congestive heart failure with the excellent efficacies that are supported by lots of clinical evidences, and the indications have been expanded. Even challenged by other RAS inhibitors, the efficacies of ACIEs remain to be excellent, and the preferred position cannot be shaken.

JCPD•CSCO Clinical Oncology

Amifostine in the Treatment of Blood System Diseases

Cell protective agents have become a new star in R&D of antineoplastic agents, and amifostine is one of the leaders with potential antineoplastic, tolerance-reversing, and normal cell protecting values, which has been widely used in a variety of blood system diseases in clinical practices.

Fan Dachao

Analysis of Bias or Violation in

Clinical Trials

Although bias and violation to the clinical trial protocol cannot be avoided, any effort should be exerted and positive measures should be taken to reduce its occurrence, because serious violation of the clinical trial protocol can directly affect the data quality of clinical trial, thereby affecting the trial result, and even can in fl uence the veri fi cation and approval of a new drug by the regulators.

(Editor Yao Lixin)