A Chance to Reflect and Look Forward
Highlighting a year of conference coverage for ACT.
Over the past few weeks, signs of 2023 coming to an end are aplenty; the temperatures have fallen, and holidays are beginning to appear more frequently on the calendar. I’m sure I’m not alone in feeling that the end of each year serves as a good time to reflect on the previous 12 months. For Applied Clinical Trials, there have been many bright spots throughout 2023. One in particular I’d like to highlight here is our conference coverage—a pillar of our many brands at MJH Life Sciences®. ACT was front and center at several of this year's largest industry conferences, including the Summit for Clinical Ops Executives (SCOPE) North America, SCOPE Europe (see our executive roundtable from the event here), DPHARM, and the DIA Annual Meeting. Our editors did a fantastic job in providing timely coverage of breakout sessions and speaking with industry leaders for video interviews. All of the content can be found here on our website:
www.appliedclinicaltrialsonline.com/latest-conference. We look forward to continuing our coverage of these events in 2024.
Not to be overlooked, of course, are present happenings. For this December issue of ACT, we focus on novel clinical trial designs. From basket trials, to using real-world evidence (RWE), and master protocols, there are many new elements to trial design. We explore some of these design approaches and how regulatory authorities are moving the needle on their acceptance.
Our first feature examines the benefits of early protocol assessment in boosting patient centricity. For example, with so many new design elements in the fold, getting ahead of potential pitfalls can greatly reduce patient burden while expanding opportunities to apply clinical data on a wider scale.
Following is a feature looking at innovation in clinical trials for chimeric antigen receptor (CAR) T-cell therapies. These products have steadily demonstrated positive results for oncology patients in recent years. The article focuses on next-step, digitally driven pursuits for CAR T-cell trials and how this area can be advanced further. Our final December feature discusses strategies for implementing digital protocols and ways to streamline processes such as content reuse, workflow animation, and study design.
As always, thank you for reading.
Mike Hennessy Jr, president and CEO, MJH Life Sciences®
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
