[Show abstract][Hide abstract] ABSTRACT: High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161-8.
[Show abstract][Hide abstract] ABSTRACT: The loss of public trust in the clinical research community, particularly in the pharmaceutical industry, came after a series of allegations focusing on selective reporting of clinical trial data by the pharmaceutical industry (2,3). Of particu- lar concern were instances in which sponsors disclosed positive results from clinical trials while leaving out the negative ones. This contributes to publication bias and can seriously impact the interpretation of data, both at the indi- vidual study level and for large data sets in meta-analyses on published studies (4-9). In an effort to address the situ- ation, the stakeholders, including the governmental agen- cies, trade associations, journal editors, the WHO, ICH, and Cochrane collaboration (Fig. 1), became proactive regarding the increased transparency of the data on clinical trials—however without always coordinating or fully anticipating consequences of their efforts. Unluckily for those affected in the clinical research community, some of the proposed or implemented actions by the stakeholders were conflicting, making compliance towards increased transparency difficult. Clinical trial registration and transparency of clinical trials has been the subject of previous articles in TWS (10,11). Here we follow up on those reports and summarize some of the latest developments on this fast-changing topic and the way these developments potentially affect all patients, pharmaceutical companies, clinical research organizations, universities or government institutes, and other individuals involved in testing of and reporting on investigational products 1 in humans. We also share some of our own expe- riences gathered while setting up the processes associated with 'Clinical Trial Disclosure' at an internationally ope- rating pharmaceutical company.
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