The statistical adequacy of all papers published in the period 1976-80 describing clinical trials of five non-steroidal anti-inflammatory and two analgesic drugs introduced into the UK market in 1978 and 1979 has been assessed using a checklist of simple criteria. Most trials were reported to be randomised and double-blind. Trial designs were less satisfactory in other important respects; the sample size of most trials was inadequate to demonstrate superiority of the new drug compared with an active control therapy. The period of treatment assessment was short in view of the likelihood of prolonged prescription of drugs in these classes. It is suggested that licensing authorities should demand higher standards of clinical trial evidence offered in support of new drugs.

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/j.1365-2125.1985.tb02626.x

Assessing reports of therapeutic trials.

Is the clinical trial evidence about new drugs statistically adequate

Publication of findings from clinical trials is a necessary step in the research continuum, to provide a record of the work done, convey information to the community, and support translation of research into clinical practice. Systematic reviews of randomized controlled trials are now widely regarded as the highest level of evidence in determining the effect of an intervention on an outcome. They largely depend on internationally accessible, published reports of all trials undertaken. Investigators and their institutions or organizations have responsibility for reporting their clinical trials accurately and completely, including disclosure of potential conflicts of interest. To ensure evidence-based health care, issues relating to accessibility and accountability of clinical trial results require immediate action.

Publication of clinical trials: accountability and accessibility.

Matching quality of agents employed in "double-blind" controlled clinical trials

The irritable colon syndrome is a symptom‐complex of abdominal pain or discomfort and altered bowel habits, in the absence of evidence of organic disease (Goulston, 1972). Because there are no objective signs, evaluation of treatment in this condition has to be based solely on subjective response of the patient.

Drug usage in the irritable colon syndrome.

Amongst the 456 papers published in the Aust NZ J Surg during 1978 to 1980, there were 91 papers (20%) that were analytical in nature. Of these publications, 71 (78%) contained errors in the usage of nondescriptive statistics. Authors often failed to test for significance when it was appropriate, quoted probability values without reference to a test, and misused basic statistical} techniques.

Assessing reports of therapeutic trials.

Citations

Is the clinical trial evidence about new drugs statistically adequate

Publication of clinical trials: accountability and accessibility.

Matching quality of agents employed in "double-blind" controlled clinical trials

Drug usage in the irritable colon syndrome.

Misuse of statistical methods in the Australasian surgical literature.