Blog
RSS FeedPosted by Michael Wonder on 08 May 2022
Supporting innovation in Medicaid policy - interventions to increase adoption of RCTs
7 May 2022 - Randomised, controlled trials remain underutilised within the Medicaid program, even though state Medicaid programs regularly implement new ...
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 21 Apr 2022
Are high cost prescription drugs the price of innovation? Disclose the costs of clinical trials.
21 April 2022 - With 40% of Americans struggling to afford prescription medicines and many rationing or delaying initiation of lifesaving ...
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 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...
Posted by Michael Wonder on 18 Mar 2022
Australian cancer patients to get improved access to clinical trials
17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...
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 03 Mar 2022
Medicines Australia welcomes reform efforts to speed up clinical trials
4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...
Posted by Michael Wonder on 03 Mar 2022
Criticism of study planning: patient-reported endpoints are often collected far too briefly
3 March 2022 - A striking example: abemaciclib in advanced breast cancer. Shortened data on quality of life, symptoms and side ...
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 ...
Posted 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 ...