Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2022
‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges
26 July 2022 - Walker Burger is beside himself with worry. ...
Posted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...
Posted by Michael Wonder on 15 Jun 2022
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: a modified Delphi approach
15 June 2022 - Pragmatic clinical trials are randomised trials implemented through routine clinical practice, where design parameters of traditional randomised ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 18 May 2022
Toward incorporating health-related quality of life as co-primary endpoints in clinical trials: time to achieve clinical important differences and quality of life profiles
16 May 2022 - Besides morbidity and mortality, quality of life is a key outcome of cancer treatments. ...
Posted by Michael Wonder on 17 May 2022
Ethical considerations for the inclusion of patient reported outcomes in clinical research
17 May 2022 - An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health ...
Posted by Michael Wonder on 12 May 2022
Basket trials: review of current practice and innovations for future trials
10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...
Posted by Michael Wonder on 06 May 2022
Patient reported outcome assessment must be inclusive and equitable
5 May 2022 - Patient reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies ...
Posted by Michael Wonder on 13 Apr 2022
FDA takes important steps to increase racial and ethnic diversity in clinical trials
13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...
Posted by Michael Wonder on 12 Mar 2022
Biosimilar impact on oncology clinical trial design and operations
11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials ...
Posted by Michael Wonder on 08 Mar 2022
FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds
7 March 2022 - Six years ago, the U.S. FDA launched a five year action plan to improve the diversity and ...
Posted by Michael Wonder on 02 Mar 2022
Progression-free survival: it is time for a new name
1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...
Posted by Michael Wonder on 02 Mar 2022
Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline
1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...
Posted by Michael Wonder on 11 Feb 2022
U.S. FDA advisers call for new trial of Lilly, Innovent lung cancer drug
10 February 2022 - Innovent Biologics and Eli Lilly should be required to conduct a trial of their lung cancer ...
Posted by Michael Wonder on 06 Feb 2022
Importing oncology trials from China: a bridge over troubled waters?
4 February 2022 - On 10 February 2022, the US FDA's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a ...