The evolving uses of “real world” data

9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...

Read more →

The importance of predefined rules and pre-specified statistical analyses: do not abandon significance

4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance.  ...

Read more →

The stepped wedge cluster randomised trial: what it is and when it should be used

1 April 2019 - The basic premise of a stepped wedge cluster randomised trial is that all clusters start in the ...

Read more →

Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward

29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...

Read more →

Effectiveness in the absence of efficacy: cautionary tales from real world evidence

21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...

Read more →

Health Canada begins release of clinical data on drugs and devices

14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...

Read more →

Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development

14 March 2019 - Modernizing clinical trials is an agency wide priority.  ...

Read more →

Marginal effects—quantifying the effect of changes in risk factors in logistic regression models

8 March 2019 - Marginal effects can be used to express how the predicted probability of a binary outcome changes ...

Read more →

Cluster randomised trials

4 March 2019 - Cluster randomised trials randomise groups of individuals rather than individuals themselves to interventions.  ...

Read more →

Treatment effects in multi-centre randomised clinical trials

1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...

Read more →

Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database

25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed.  ...

Read more →

Modernising clinical trials for patients with cancer

23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...

Read more →

Random-effects meta-analysis: summarising evidence with caveats

22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...

Read more →

Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo

18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...

Read more →

FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls

16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...

Read more →