Andy Studna, Editor

Preliminary Phase II trial data showed tobevibart and elebsiran combination achieved high rates of virologic response.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

Results showed significant reduction in plasma levels of neurofilament light chain after one year of treatment, a key biomarker of nerve cell damage in relapsing MS.

In the fifth and final part of this video interview, Diane Lacroix, vice president, clinical data management, eClinical Solutions looks to the future and touches on what the use of AI in clinical trials could like in five years.

In part 4 of this video interview, Diane Lacroix, vice president, clinical data management, eClinical Solutions discusses what industry stakeholders should be keeping top of mind when integrating AI into their workflows.

Almost 90% of centers reported shortages for at least one type of systemic therapy.

In part 3 of this video interview, Diane Lacroix, vice president, clinical data management, eClinical Solutions touches on some of the greatest benefits she has seen with the integration of artificial intelligence into data management.

Guidance provides details to assist medical product sponsors in submitting Diversity Action Plans.

In part 2 of this video interview, Diane Lacroix, vice president, clinical data management, eClinical Solutions highlights how artificial intelligence can help industry keep pace with the increasing complexity of data.

CAR T cell therapy candidate will be evaluated in Phase I multicenter, open-label clinical trial.

In part 1 of this video interview, Diane Lacroix, vice president, clinical data management, eClinical Solutions discusses the current landscape of data collection in clinical trials and the growing complexity of protocols.

Recent study reviewed how often patient-reported outcomes were being used as primary endpoints in randomized studies.

Up to 51.5% of participants met the criteria for disease resolution.

In an interview with ACT editor Andy Studna at DIA 2024, Beakes-Read, head, global regulatory policy and intelligence, Johnson & Johnson Innovative Medicine highlights the integration of technological advancements into drug development and benefits patients are seeing from FDA's Accelerated Approval Program.

In an interview with ACT editor Andy Studna at DIA 2024, Cuff Shimooka, chief operating officer of TransCelerate Biopharma touches on how collaboration will be key to innovation in clinical research moving forward.

In an interview with ACT editor Andy Studna at DIA 2024, DiCicco, vice president, portfolio management, TransCelerate Biopharma highlights the use of artificial intelligence in clinical research from the perspectives of different stakeholders.

In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial officer of CluePoints touches on collaboration with FDA and using artificial intelligence in clinical research.

Session highlights the value of simulations such as data analysis and endpoint selection in clinical development.

In an interview with ACT editor Andy Studna at DIA 2024, Dabbs, vice president, global product strategy, IQVIA highlights challenges with tech overload and how stakeholders can choose which solution(s) are best for their studies.

In fourth and final part of this video interview, Marc Buyse, founder, and Sebastien Coppe, CEO; both of One2Treat emphasize the importance of personalizing oncology studies and giving patients more choices.

In part 3 of this video interview, Marc Buyse, founder, and Sebastien Coppe, CEO; both of One2Treat highlight how to simplify the design of oncology studies by using prioritized outcomes.

Summit Partners, an investor in the RBQM software provider since 2020, and Clinimetrics SA, a co-founder, will retain minority stakes.

In part 2 of this video interview with Marc Buyse, founder, and Sebastien Coppe, CEO; both of One2Treat, Buyse touches on dosing, toxicity, and quality of life for patients in advanced disease states.

New solution provides a continual cycle of analysis throughout a trial to ensure feasibility.

In part 1 of this video interview, Marc Buyse, founder, and Sebastien Coppe, CEO; both of One2Treat discuss the importance of designing oncology studies with multiple outcomes and how it can benefit patients.

Survey study shows the importance of balancing the delivery of timely systematic reviews while maintaining quality in clinical trials.

Industry leaders discuss the progress and path forward for the clinical trials enterprise in meeting its environmental mandate.

Global, multicenter, randomized, open-label, parallel-group study will evaluate ABBV-383 in adult patients with relapsed/refractory multiple myeloma.

Results from new analysis show RYBREVANT plus lazertinib consistently and significantly improved progression-free survival compared to osimertinib.

Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader range of regulatory concerns.