Blog
RSS FeedPosted by Michael Wonder on 14 Mar 2019
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. ...
Posted by Michael Wonder on 09 Mar 2019
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 ...
Posted by Michael Wonder on 04 Mar 2019
Cluster randomised trials
4 March 2019 - Cluster randomised trials randomise groups of individuals rather than individuals themselves to interventions. ...
Posted by Michael Wonder on 02 Mar 2019
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, ...
Posted by Michael Wonder on 25 Feb 2019
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. ...
Posted by Michael Wonder on 23 Jan 2019
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 ...
Posted by Michael Wonder on 23 Jan 2019
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 ...
Posted by Michael Wonder on 18 Jan 2019
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 ...
Posted by Michael Wonder on 17 Jan 2019
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 ...
Posted by Michael Wonder on 16 Jan 2019
Sweet smell of success for patients taking the sugar pill
15 January 2019 - A placebo is anything that seems to offer a real medical treatment, but doesn’t. It could ...
Posted by Michael Wonder on 16 Jan 2019
Challenges of non-intention-to-treat analyses
15 January 2019 - Over the past 5 decades, the randomised clinical trial has become the gold standard for evaluation ...
Posted by Michael Wonder on 18 Dec 2018
Establishing the effectiveness of procedural interventions: the limited role of randomised trials
18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 03 Dec 2018
Australia's first telehealth cancer drug trial
3 December 2018 - A partnership between north Queensland hospitals is bringing potentially life-saving cancer drug trials to rural patients. ...
Posted by Michael Wonder on 29 Nov 2018
The evolution of adaptiveness: balancing speed and evidence
29 November 2018 - 'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years. ...