Articles By Dan Schell, Chief Editor
DAN SCHELL ARTICLES
2024: Familiar Problems & Encouraging Progress
For part 1 of my 2024 recap, I asked various industry experts what stood out to them this year regarding the clinical trials industry. They mentioned significant challenges related to site capacity, enrollment, workforce changes, and trial complexity, but they also seemed encouraged with some of the efforts and emerging solutions that will address these issues.
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Can Better Data Management Save Clinical Trials?
In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.
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PI Insights From A Heart Failure Trial: Part 2
This is part 2 of Dan Schell’s interview with Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial. Here, she elaborates more on some of her tasks specific to this heart failure trial.
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PI Insights From A Heart Failure Trial: Part 1
Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.
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Not A Bad First Year
Dan Schell, chief Editor or Clinical Leader, summarizes his first year in this role and highlights some of his key takeaways and lists some of the people who have helped him better understand the clinical trials ecosystem.
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We Are All Project Managers, But We Need Help
Jess Thompson is a champion of project managers. Not only is she working to validate their role in the clinical trial ecosystem, she wants to spread the word that we all perform PM-types of duties. Also, if we could get better as an industry at incorporating some of those basic tenants of project management, perhaps we could see more drugs succeed — and quicker.
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Plodding Toward Better Data Integration & SSO
Laura Hilty, a principal at HealthX Ventures, talks about the need to better integrate data platforms and improve/enable single sign-on (SSO) solutions so sites can lessen their administrative burden.
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A New Barometer For Clinical Outsourcing Performance
Interested in how some of the top publicly traded clinical development outsourcing companies are doing in the market? Andrew Schafer may be able to help with his Schafer Clinical Development Index (SCDI).
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Want To Improve Study Startup? Get More Efficient
John McAdory, VP of ClinOPs at CG Oncology, recognizes that today’s clinical trial designs tend to be very complex, which complicates study startup. He says the key to improving this challenge is to find small ways to be more efficient throughout the process.
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AI Can't Help Bad ClinOps/Health Equity Data
Brian Johnson, Ph.D., VP, R&D Technology at Takeda discusses the huge opportunity of connecting disparate ClinOps data and leveraging generative AI to reduce costs and labor during the clinical process.
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Key Takeaways From Clinical Trial Diversity Discussion
During the Clinical Leader Live, The Diversity Mandate: Effective Strategies in Clinical Trials”, we discussed everything from the guidance, to diversity action plans, to the need for better data on race, ethnicity, and identity. In this article, we also share 25 questions audience members had regarding this hot topic.
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We Need More Clinical Trial Awareness … Oh, And CRCs
Christina Brennan, SVP for the clinical research program at Northwell Health, talks about how increasing the awareness of clinical trials can lead to better patient-centricity and why we need to start positioning clinical research as a career.
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Not What I Expected From A Vendor Conference
Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites.
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FDA Under Pressure To Respond To China-Related Clinical Trials Questions
The FDA has until October 1, 2024 to respond to a number of questions regarding concerns about clinical trials being conducted in The People's Republic of China. How will their answers affect trials going forward and the sponsors that were conducting those China-based trials?
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Are You Afraid Of Adopting New Outsourcing Models?
Pricing strategies for outsourcing clinical services have evolved over the years, yet many sponsors are reluctant to change from their status quo. That may change, though, as CROs begin to add technology and site networks to their offerings.
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Why We Need Technology Consolidation In Clinical Trials
As more and more trial designs incorporate technologies that generate an immense amount of data, data managers struggle to continuously interconnect disparate systems and standardize data. All of this fuels the need for technology consolidation.
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Government Contract Advances Walgreens In Clinical Space
Walgreen’s new $25 million deal with BARDA (Biomedical Advanced Research and Development Authority) is a huge win for the pharmacy chain. John Campbell, head of DCTs at Walgreens, explains the ins and outs of the study and what could be next for the company regarding its clinical trials division.
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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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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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