July 24th 2020
While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
Demographic Disparities in Patient Samples for Drugs and Biologics Approved by FDA Between 2007-2017
April 10th 2020Diversity in clinical trials is an important part of developing new medications that are safe and effective for all potential patients, understanding the demographic disparities within them will provide several benefits to the field.
6 Steps During Pandemic to Support the Needs of Patients and Sites
April 6th 2020The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.
Are New Medicines Being Developed to Meet the Needs of the Ever-Ageing Population?
February 28th 2020The elderly population is still underrepresented in clinical trials, with nearly a third of newly registered drugs included an insufficient number of elderly participants, leading to uncertainties regarding safety and effectiveness for prescribers.
Assessing Suicide Risk in Clinical Trials: The Patient Knows Best
January 22nd 2020During clinical trials of pharmaceutical treatments, sponsors and CROs need to detect possible suicidal ideation and behavior related to their drug during baseline assessments, and throughout treatment as well as during the follow up phases.
Patient Engagement and Advocacy: Advancing the Cause of Clinical Drug Research
January 6th 2020For years, Duchenne muscular dystrophy drug trials included a specific endpoint requiring that they enroll only patients who were still able to walk. That changed when a DMD-focused advocacy organization took the matter up with the FDA and helped develop new trial guidelines.