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This article has Open Peer Review reports available.

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Trials 2009 10 :46

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© Wu et al.; licensee BioMed Central Ltd.2009

Received: 17September2008

Accepted: 02July2009

Published: 02July2009

Open Peer Review reports

Abstract

Background

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups.

Methods

The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials.

Results

From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0).

Conclusion

Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Traditional Chinese Medicine Measle Allocation Concealment Conventional Medicine Random Sequence Generation

A systematic review has found that some countries, including China, report unusually high proportions of positive results in published randomized controlled trials (RCTs) [ 1 ]. One factor that may contribute to this effect is selection bias. It has been shown that inadequate randomization approaches result in estimates of treatment effects that are more favorable than those derived from properly randomized trials [ Salvatore Ferragamo Feel Slingback Pumps clearance limited edition qfIDV0nK
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] provides insight into this methodological shortcoming in trials conducted in China. In an effort to evaluate the benefits and harms of Chinese medicinal herbs in the treatment of measles, they identified a total of 28 reports of randomized trials that appeared to meet their eligibility criteria. As part of their review they conducted telephone interviews of 19 corresponding or first authors and discovered that the study authors had used inappropriate methods to generate the random sequence list and had not adequately concealed the participant allocation. These studies could therefore not be regarded as authentic randomized trials. Although this is a disturbing result, it is difficult to assess whether it represents a misunderstanding on the part of a few researchers about fundamental methodological issues in the conduct of randomized trials, or whether it reflects a larger problem prevalent among trials conducted throughout China. In this study, we therefore aimed to investigate the adequacy of randomization of RCTs published in Chinese journals and the extent of the authenticity of randomized trials using a large cross-sectional sample of the Chinese literature.

Twenty-one investigators searched the China National Knowledge Infrastructure electronic database for the period January 1994 to June 2005, for trials written by Chinese researchers and published in Chinese journals on a convenient sample of 20 common diseases. Any trial described by the authors as an RCT or that claimed to have used random sequence generation or allocation concealment was considered eligible.

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” has taken quite the Tolstoyan journey on both sides of the camera since the pilot for the FX espionage drama was shot in the spring of 2012.

Since then, Russian spies Philip and Elizabeth Jennings, played by Matthew Rhys and Keri Russell, have donned countless disguises, killed dozens of fellow travelers (and a few innocents), and raised two kids under the cover of being a typical American family in suburban Washington, D.C.

As the show prepares for the launch of its sixth and final season on March 28, Variety spoke with showrunners Joe Weisberg (creator of the series) and Joel Fields and a host of other key players about what made the show unique, how it evolved over 75 episodes, and how they are bringing it in for a landing.

Here are highlights of those conversations:

Joe Weisberg : It all goes back to the marriage. It started out as a show about a marriage and it stayed that all along. It’s about a couple in a very odd and unusual situation. Despite that, everything they experience and felt and went through we always thought could be relatable to everyone. Everybody involved in the show was drawn to this couple and to their marriage and drawn to the idea as it started out that he was more in love with her than she was with him. But from the very beginning in the pilot something happened and she started to soften and pull back to him. We talk a lot about history and politics and what it means to have enemies that are not that different from you. it is an important part of the show. what makes you feel in this show is that marriage.

Joe Weisberg

Joel Fields : I remember reading this book on Israeli startup companies and one of the things it said is that the Israeli Army has a policy that every day, even if they’re at war, they all stop and talk about how the battle’s going. Even if they’re in the middle of the battle, they stop and discuss how it’s going and they think that’s one of the reasons why the companies are successful. That first season for us was not a battle by any stretch. No real people were being killed but a lot of fictional people were being killed. We were working very hard and crazy long hours. We traded sleep sometimes for talking about process. It’s really served us well. It’s served our friendship well and it’s really served our working collaboration well.

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