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Andrew Mackinnon, executive GM, Medable, explains how the company ensures high patient participation and data accuracy in decentralized trials.

Intrathecal onasemnogene abeparvovec (OAV101 IT), an investigational, one-time gene replacement therapy, demonstrated a statistically significant improvement in HFMSE in the Phase III STEER study.

COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

The pivotal Phase III study in myasthenia gravis met its primary endpoint with meaningful improvements in MG-ADL across both higher and lower dose arms.

Phase III DIPPER trial shows that adjuvant camrelizumab administered after induction-concurrent chemoradiotherapy significantly improved event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma, along with a favorable safety profile.

In this video interview, Cameron Breze, product manager, Inovalon, discusses the need for accurate information in creating useful clinical data.

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.

In this video interview, Cameron Breze, product manager, Inovalon, talks clinical technology and how the industry is working to increase comfortability with its implementation.

New data from the Phase II RAINFOL-01 study shows rinatabart sesutecan (Rina-S), an investigative antibody-drug conjugate, demonstrated a confirmed objective response rate of 55.6%.

In this video interview, Cameron Breze, product manager, Inovalon, discusses current challenges with patient recruitment and how a combination of technology and manual effort can help improve efficiency.

In the Phase III MIRASOL trial, Elahere (mirvetuximab soravtansine-gynx) significantly improved progression-free survival and overall survival compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer.

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.