Media hype has created the caricature of a malevolent trialist, gleefully suppressing data for their own publication record. But has anyone investigated what it’s like from the trialists’ point of view?

Randomized controlled trials are praised as one of the highest forms of evidence in healthcare. However, to be valuable, all research must have valid methods, and be reproducible and useable.

The usability of research is affected by a multitude of factors, stemming from the research not being reported in sufficient detail. Clinical trials particularly have come under heavy fire recently, with a few very high-profiles cases highlighting some of these issues.

TheTamiflu case, where the full evidence suggested no additional benefit over paracetamol, highlighted major impacts from publication bias and selective outcome and analyses reporting, whereas the case of selective serotonin reuptake inhibitors(SSRIs) increasing the risk of suicide强调灾难性的危害报告对患者的报道不足。

源于此类故事的媒体炒作创造了一位恶意的试验者的讽刺漫画，欢呼地抑制了自己的出版记录的数据。

But, in a world dominated by regulation, funders and grant applications, has anyone actually asked the trialists?

Excuse me Trialist, what are your thoughts?

丽贝卡·史密斯（Rebecca Smyth）和同事们开始这样做。他们确定了286名审判员，他们要么发表了一项在Cochrane系统评论中涵盖的审判ORBIT project或在2007年至2008年之间从PubMed中随机采样，采访了回答的59条。

These interviews highlighted issues for trialists relating to five major stages of the clinical trial process:

• 构建研究问题，
• 定义关键结果，
• The role of the study protocol,
• 进行研究，
• Getting the research published.

Many of the reported challenges have been highlighted前, but the importance of qualitative studies to gain insight from those on the front-line of research, as well as provide depth and detail to the evidence-base, cannot be underestimated.

总是会有一些发现disheartening. Thirty-three trialists commented that, independent of outcome, they had never chosen to withhold from publishing their results; however, sixteen of these (48%) said they had been involved in a trial that was never published, 3 of which were industry-funded:

“…that was an industry sponsored trial… Not only was it a negative result but the study was stopped early because of safety. And that has not been published.”

…不仅是一个负面的结果，而且由于安全性，该研究早日停止。而且尚未出版…

---

接受采访的审判员
Smyth and colleagues,试验2015

所以，我们能做些什么？

Existing initiatives concentrate on combating issues at the final stage of a clinical trial, i.e. publishing the results. But Smyth and colleagues identified issues for trialists that occur in many of the stages leading up to, and ultimately contributing to, this final stage.

报告指南,年代uch as those from theEQUATOR Network, including配偶，为最低报告项目提供指导，以确保研究透明且可重复。但是，如果审判员在拒绝文章之前没有看到它们或没有转介给他们，那为时已晚。试验人员需要通过整个审判过程意识到这些准则，以使他们产生预期的影响。

因此，也许我们需要集中精力，不仅是临床试验的最后阶段，而且还要放在所有其他会影响最后阶段的阶段。

Some projects are already underway with the goal of supporting better trial design and reporting practices, including the National Institute of Health ResearchClinical Research Network和Trial Forge，但是他们走得足够远吗？

In particular, difficulty in defining key outcomes was highlighted by those interviewed. When it comes to defining key outcomes, theCOMET Initiativeaims to develop standardized sets of outcomes for specific conditions, an agreed minimum of what should be measured during clinical trials.

这些应将其纳入研究方案中，这应该是试验的“操作方法指南”，并构成其最终报告论文的核心。创建协议的审议和细节意味着依从性应有助于临床试验过程的所有阶段。但是，一些审判者提到，完成后，该协议被搁置和遗忘了：

“…You write the protocol you spend months doing it, and you have got a really good grasp of it and then as the trial progresses the protocol fades…”

Another recurring theme was that of recruitment and retention, something that will feel all-to-familiar to many trialists out there. Many of those interviewed commented on difficulties achieving their target sample sizes:

“…it was supposed to be a huge trial, looking to recruit 1800 men, and we closed after two years with 35 randomized, so clearly you are not going to get anything useful out of that…”

While this is a well-known bugbear, perhaps it is time to acknowledge that some of these trials should never have gone ahead. Does this show we are doing too many trials? Instead, maybe we should be conducting morepilot studies with predefined feasibility outcomesfor factors such as recruitment, to give a clear go/no-go for definitive trials.

Whatever the future may hold for the clinical trial process, we need to ensure that the voice of all parties involved are heard.

30/01/15: *Update to text*: paragraph 9 has been updated. The original paragraph read, “There are some findings that will always be disheartening. For example, 48% of trialists interviewed stated they had been involved in a trial that was never published:”