DIA: Driving Insights to Action
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In this DIA 60th anniversary interview, former Board President Ling Su shares his thoughts on the two most important aspects of DIA’s future for the next generation of members.
Good Publication Practice (GPP) experts explain the authorship algorithm designed to weigh each author's contribution relative to other authors' contributions in a study, and to define appropriate ways to establish the authorship byline.
Accumulus Synergy CEO Francisco Nogueira shares expectations for the outcomes of a post-approval changes pilot led by Roche which utilizes the Accumulus platform and follows WHO principles of good regulatory reliance practices.
Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024.
A few years ago, 8-year-old Autumn noticed a lump on the side of her neck as she was preparing for bed one night. That quiet night opened a new chapter not only in Autumn’s life but in the life of her entire family: Autumn had leukemia. In this
In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What's really changed and what
In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement trac
DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Adv
“Healthcare systems obviously have as their primary role the delivery of healthcare,” says Steve Webb, Australian Clinical Trials Alliance board chair. “But we can see big improvements in health outcomes, combined with substantially better fina
For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product quality. ANVISA’s new Online Optimized Assessment P
“The pandemic had a substantial impact on community understanding of clinical trials. Having said that, the sort of ambient level of community knowledge of clinical trials is still substantially lower than it needs to be,” explains Australian C
From microphysiological systems and digital pathology to next-generation-sequencing and diversity in foundational genomic data sets: In this iteration of our annual year in review podcast, Global Forum Co-Editors for Translational Science Gary
While the African Medicines Agency (AMA) plans and plants its inaugural headquarters in Rwanda, the European Commission, the European Medicines Agency (EMA), several EU Member States, and the Bill and Melinda Gates Foundation continue to mobili
Clinical trials struggle to enroll eligible patients, while interested patients have difficulty finding pertinent clinical trials. Can technology help solve this people problem? “Typical patient recruitment happens based on historical data at r
Actions to increase patient diversity in clinical research initially addressed racial and ethnic demographics but are expanding to address gender identity. “Further research can only help us better understand the differences in our bodies and i
Digital technologies are rippling through clinical research and care, promising deeper links between healthcare research and delivery. In her interview with Global Forum US Editor Ebony Dashiell-Aje (BioMarin), Digital Medicine Society CEO Jenn
DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemica
The World Health Organization has initiated a pilot coordinated scientific advice (CSA) procedure whereby product developers may obtain WHO advice on the most appropriate way to generate evidence on a product's benefits and risks. “WHO has been
In 2021, the 74th World Health Assembly adopted the Global Patient Safety Action Plan (GPSAP) 2021-2030 towards eliminating avoidable harm in healthcare. “Here in the United States, the Office of the Inspector General reports that one in four M
In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and C
The Cancer Moonshot launched in 2016 with a Blue Ribbon Panel Report featuring 11 recommendations, including creation of human tumor atlases and a national cancer data ecosystem, for improving cancer research and care in the US. In February 202
In March 2022, the Tufts Center for the Study of Drug Development (CSDD) issued an impact report that examines clinical trial budgets and factors that drive commonly observed variations and cost. “Part of the focus of all of these studies is to
While COVID-19 sharpened global understanding of the importance of efficient medicines review and regulation, the Pan American Health Organization (PAHO) has been systematically assessing national medicines regulatory authorities in the America
“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making
In Part 2 of this interview, Chief Executive Officer Francisco Nogueira discusses the practicalities of data capture, data management, and machine learning within the framework of Accumulus Synergy’s proposed global cloud-based platform for reg
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