Andy Studna, Editor

Mixed methods study gathered responses from study investigators to identify barriers, solutions, and opportunities associated with continuing critical care randomized trials during the pandemic.

Newly released research report from Information Services Group suggests firms are moving away from traditional, centralized trials in favor of remote technologies.

deLaubenfels addresses key challenges seen by sponsors and highlights the value cough monitoring can provide.

Topline results from the 52-week open-label trial show the treatment was well tolerated with a safety profile consistent with standard-of-care.

The potential treatment for chemotherapy-induced peripheral neuropathy will be evaluated in a single ascending dose study.

Del Smith, PhD, co-founder & CEO of Acclinate highlights challenges sponsors may face in light of FDA releasing its Diversity Action Plan guidance.

Emerging data from Phase I first-in-human, dose-escalation study showed promising survival and progression-free survival rates.

Smith shares his initial thoughts on the guidance and what its impact will be on the industry moving forward.

Once-daily formulations of the oral GLP-1 receptor agonist resulted in encouraging pharmacokinetic data for several candidates, including one showing the most favorable profile.

In the fourth and final part of this video interview, Kristy Birchard, product owner, patient engagement, YPrime discusses the importance of designing products based on the experience of patients.

In part 3 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime touches on the importance of utilizing patient-reported outcomes.

Under the new agreement, a Phase II study will commence to evaluate the combination in patients with SMARCA4-mutated cancers.

In part 2 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime discusses the work she is currently doing within patient centricity and how to effectively reach patient communities.

Data emerged from the IDE397 Phase II monotherapy expansion dose in methylthioadenosine phosphorylase-deletion urothelial and non-small cell lung cancer patients.

In part 1 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime highlights the importance of patient centricity in trial design.

Study will evaluate the potential therapy in combination with checkpoint inhibitor in patients with malignant solid tumors.

Phase I dose escalation study expected to begin in the second half of 2024; initial data expected in the first half of 2025.

Preliminary results from study of small interfering RNA drug candidate, STP707, indicated the average days for stable disease in patients was 92.

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 highlight the potential impact FDA's Diversity Action Plan guidance will have on industry.

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.