Blog
RSS FeedPosted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
Posted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 20 Dec 2021
Biased Outcome reporting Guidelines for Underwhelming Studies (BOGUS) statement and checklist
10 December 2021 - A light hearted article to end the year. Merry Christmas to all our readers. We will ...
Posted by Michael Wonder on 08 Dec 2021
Improvements to clinical trials will strengthen Australia’s economy and benefit patients
8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...
Posted by Michael Wonder on 02 Dec 2021
Call for a central portal for clinical study reports
1 December 2021 - In an open-access publication in the Journal of European CME, two authors from IQWiG argue that ...
Posted by Michael Wonder on 23 Nov 2021
Use of confidence intervals in interpreting non-statistically significant results
23 November 2021 - The goal of much of medical research is to determine which of 2 or more therapeutic approaches ...
Posted by Michael Wonder on 13 Nov 2021
Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements
12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to ...
Posted by Michael Wonder on 11 Sep 2021
Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment
9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials
3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...