News

Addressing data integrity and compliance concerns.

The BRAVE-AA-PEDS trial found that once-daily baricitinib significantly improved hair regrowth on the scalp, eyebrows, and eyelashes in adolescents with severe alopecia areata after 36 weeks, with faster response rates compared to adults.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies.

The combination demonstrated non-inferiority to comparator antiretroviral therapies, meeting the primary efficacy success criterion in both trials.

Phase I trial results show the potential of once-yearly lenacapavir as a long-acting PrEP option for HIV, supporting further clinical development in a more diverse population.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, talk technology and how it can save time in the recruitment process.

Icotrokinra met all primary endpoints in the studies, demonstrating significant skin clearance and clinical remission.

A meta-analysis of 11 trials shows that Padcev (enfortumab vedotin-ejfv), both alone and in combination with Keytruda (pembrolizumab), significantly improves response rates and survival outcomes compared to conventional chemotherapy in metastatic urothelial carcinoma.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how industry can improve on truly understanding the unique circumstances of patients.

Sotyktu (deucravacitinib) demonstrated significant efficacy in improving psoriatic arthritis symptoms compared to placebo in the Phase III POETYK PsA-2 trial, with a well-tolerated safety profile.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, address the challenge of patients not being informed of clinical trials by their primary doctors.

Addressing systemic barriers and biases faced by women in research to foster a more diverse talent pool.

Genomics has long been a primary focus in precision medicine, but other areas of research are increasingly being used to help attain a more complete picture of how an individual’s complex biology impacts their health profile.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, highlight the results and how patients are interested in learning more about clinical trials relevant to their condition.

Teams must work together with technology solutions and optimize integration to unlock their full potential.

Phase III MATTERHORN trial data show a statistically significant and clinically meaningful improvement in event-free survival for patients with resectable gastric and gastroesophageal junction cancer when treated with perioperative Imfinzi (durvalumab) plus FLOT chemotherapy compared to chemotherapy alone.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, talks innovation in clinical technology and how the FDA can continue to promote its adoption.

Tris Pharma’s first-in-class oral dual-NMR agonist achieved its primary endpoint in the ALLEVIATE-2 study by demonstrating a statistically significant and high level of pain reduction compared to placebo.

Phase III REMIX-1 and REMIX-2 trials demonstrated that remibrutinib, an oral BTK inhibitor, significantly reduced chronic spontaneous urticaria symptoms in patients unresponsive to second-generation H1-antihistamines.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, discusses the need for change in the clinical research industry and how the adoption of new technology can increase operational efficiency.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, highlights the need for a satellite model in bringing clinical trials to more rural locations.

Ron Lanton, Partner, Lanton Law, shares his insights on the legal and political consequences of the NIH funding freeze and potential options for continuing research.

Ron Lanton, Partner, Lanton Law, discusses the impact of diversity bans and political challenges on the clinical trials industry.

Phase III WAYPOINT trial shows Tezspire (tezepelumab) significantly reduces nasal polyp size and congestion severity in patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps, while also decreasing the need for surgery and systemic glucocorticoids.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, shares his thoughts on the current climate of clinical research following NIH funding cuts and the removal of FDA diversity guidelines.

Ron Lanton, Partner, Lanton Law, discusses how stakeholders must navigate funding future clinical research amid NIH budget cuts.

Current industry trends align with the need for improved, fit for purpose technology.

Xolair (omalizumab) shows superior efficacy and safety compared to multi-allergen oral immunotherapy in treating food allergies in the Phase III OUtMATCH trial, suggesting the potential to facilitate the introduction of allergenic foods into patients' diets after treatment.

A tool-based approach can significantly aid in the harmonization of regulatory requirements, mitigate inadvertent risks, and encourage collaboration by making data sharing more efficient and secure.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, talks FDA’s latest protocol deviation guidance and potential changes to the draft.