Articles By Dan Schell, Chief Editor
DAN SCHELL ARTICLES
Easy Mistakes To Make During An FDA Inspection
As a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.
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Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3
Despite the psychedelics industry reeling from Lykos’ recent failed FDA hearing, MindMed is riding high after a positive End-of-Phase 2 (EOP2) meeting with the regulator that has set up the small biopharma for a Phase 3 trial of its LSD-based treatment for generalized anxiety disorder (GAD).
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A Look At 5 Years Of CRO Leadership Awards
Are the same companies winning the CRO Leadership Awards year over year? I decided to look back at the data to find out.
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Insights Into TMF Challenges & Solutions — Part 2
In part 2 of this two-part Q&A, Nicole Palmer, CEO and president of consulting firm Granular Level, gives some good career advice for TMF professionals and talks about TMF audits and the EU’s Clinical Trials Information System (CTIS).
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Insights Into TMF Challenges & Solutions — Part 1
This is part one of a two-part Q&A I did with Nicole Palmer about a variety of issues surrounding the trial master file (TMF). In this part, she talks about the TMF Reference Model, moving to an eISF, and challenges with e-signatures.
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Siteless DCTs Are Real … And Happening Now
Siteless DCTs (decentralized trials) are rare, but Praxis Precision Medicines is running one now for patients with essential tremor (ET). Marcio Souza, PharmD, the company’s president and CEO, talks about why they chose this model and the surprising speed at which it is progressing.
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A Couple's Plan To Revamp Poland's Clinical Trial System
Hanna and Artur Preus collected and analyzed 3,208 questionnaires from patients, pharma companies, CROs, site staff, and private companies to identify the shortcomings in the Polish clinical trials system and then make recommendations on how to improve it.
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How DIA Continues To Enhance Its Global Annual Meeting
After his first year at the helm of DIA, president and CEO, Marwan Fathallah, talks about some of the key changes and highlights at this year’s global annual meeting.
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Clinical Outsourcing Observations And Predictions
Industry expert Samir Shah talks about why the FSP model is so popular these days and how site networks could become a replacement for CROs in some situations. He also suggests a new type of contracting model that could save sponsors and sites money.
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Competitors Need To Collaborate On Digital Biomarkers
Regeneron’s second annual Digital Biomarkers Summit is a good example of how competing pharma companies can work together in a noncompetitive environment for the industrywide goal of advancing the use of digital biomarkers in clinical trials.
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For Hybrid Trials, Have Some Faith … In Sites
Noelle Gaskill believes the key to regulatory success with a DCT is to not force a bunch of tech onto sites, but instead, choose those that already have the needed technology and experience and then let them do what they do best – execute on the trial.
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What To Expect From An FDA Inspection
Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.
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Why Can't We Compare Site Performance Measures?
Cerdi Beltré believes it’s possible to develop a global and objective way to measure investigator site performance for metrics such as startup duration, screen-pass rates, or rate of enrollment. It just won’t be easy … or make some sites happy.
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Ignoring Digital Biomarkers Will Be Your Undoing
We are still in the early days of uncovering all the advantages of digital biomarkers. “It’s difficult to figure out what you can measure repeatedly and with some sense of validity,” says Bari Kowal, SVP, development operations, portfolio management & biostatistics data management at Regeneron.
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4 Questions About A Digital Therapeutic Clinical Trial
Tim Peters-Strickland, SVP, clinical development & medical affairs at Click Therapeutics, explains some of the details that went into the recently FDA-approved Rejoyn digital therapeutic, which was a joint collaboration between Otsuka and Click.
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Dear Data Analysts, AI Is Not Replacing You
Deep beneath the ongoing narrative of AI’s potential use cases in clinical trials is the same fear that persists in other industries facing this technology revolution. Namely, will jobs be lost and replaced by machines? So, I thought I’d ask an expert — a machine.
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Why Jane Myles Believes DCTs Are “Completely Doable”
If you want to know about how perceptions regarding DCTs are changing, talk with Jane Myles of the DTRA (Decentralized Trials & Research Alliance). As Program Director at DTRA, she is acutely aware of all the challenges and opportunities surrounding anything with the term “decentralized trial.”
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How Takeda Leverages Cultural Competency Training To Improve Diversity
Karen Correa, VP, head global clinical operations at Takeda, details some uncommon ways the pharma is tackling the problem of diversity in clinical trials.
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Do ClinOps Professionals Understand The CAR-T Supply Chain?
Lee Clough RN, HP, of Novartis talks about the importance of understanding the nuances associated with collecting and shipping autologous material (i.e., CAR-Ts) for clinical trials.
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Ramblings From A First-Time SCOPE Attendee
Dan Schell, chief editor of Clinical Leader, discusses what sessions stood out to him and some of the KOLs he rubbed elbows with while attending his first SCOPE Summit.
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No Surprise: Patient Recruitment Still Sucks
Patient recruitment expert Ross Jackson talks about why this part of the clinical trials ecosystem is still a problem and offers up some solutions, specifically around digital/social media outreach.
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A Tribe Called SOS
A first-hand account of a first-time industry conference. Dan Schell, chief editor of Clinical Leader, talks about his impressions of the Save Our Sites (SOS) conference that happened in Tucson, AZ on Feb. 2, 2024.
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It's Hard To Predict AI's Real Value To Clinical Trials
Sunny Kumar, a partner at GSR Ventures, plans to talk about AI and ML use in clinical trials during the SCOPE Summit panel, “The Future of Clinical Trial Tech: Perspectives from Different Investors.”
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The Impact Of Protocol Design On An IRT System
DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT.
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What Is Clinical Trial Tokenization?
Tokenization in clinical trials is still a new concept to many sponsors — and their patients who are volunteering for the studies. At his SCOPE Summit presentation, Tom Dougherty of Pfizer will explain this concept and discuss what trials are a fit.
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A Closer Look At How RBQM Has Evolved In Recent Years
Mary Arnould, senior director, program management/RBM lead, Clinical Science Operations at Astellas, talks about her SCOPE Summit 2024 presentation called “COVID-19 Pandemic Impact on Risk-Based Quality Management.”
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Founders & Innovators To Share Clinical Trial Tech Insights
Jodi Akin, founder of Hawthorne Effect, discusses some of the topics she will cover on the SCOPE Summit panel titled, “Overcoming Hurdles to Fundraising, Pilots, and Scaling” as part of the colocated Clinical Trial Tech: Venture, Innovation & Partnering event.
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A Closer Look At Precision Medicine Clinical Trials
As Sumitomo Pharma America (SMPA) starts to focus more on precision medicine, the sponsor is encountering a new set of challenges when it comes to running clinical trials.
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How Re-educating PIs Can Improve Clinical Trial Diversity
Usually, discussions around ways to improve diversity in clinical trials focus on changing traditional protocol-design processes, finding and tapping into larger pools of diverse patients, educating patients on the value of clinical trials — that type of stuff. You don't normally hear people talking about re-educating physicians as a solution.
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Can Data Help Improve Diversity In Clinical Trials?
Denise Bronner Ph.D., director of diversity, equity, and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM) talks about some of the types of datasets that can be leveraged to improve diversity in clinical trials.
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Dan Schell
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Dan Schell is Chief Editor of Clinical Leader where he writes about topics related to clinical trial operations. Previously, he served as the Editorial Director of Life Science Leader magazine, another Life Science Connect community, for 14 years. In this role, he worked with the publication’s internal and external writers and editors on choosing the best topics for articles as well as refining all content to meet Life Science Leader’s high editorial standards. Prior to his work with Life Science Leader, he worked as an editor and copy editor for the publication’s parent company, VertMarkets (now called Life Science Connect). He joined the company in 2000 after 10 years of working for Encompass Health (previously Healthsouth) in marketing and business development and four years at an advertising agency.
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