The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.
- How Takeda Leverages Cultural Competency Training To Improve Diversity
- A Better Recipe For Sourcing Your Clinical Trial
- A Structured Approach To Regulatory Information Management Vendor Selection
- Supplying Complex, Controversial, And Intercontinental Clinical Trials
- 4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
- Navigating China's Biologics Approval And Accelerated Pathways
- Community-Driven Registries Drive Understanding Of Rare Diseases
GUEST COLUMNISTS
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Community-Driven Registries Drive Understanding Of Rare Diseases
In an effort to increase and diversify research, the Pulmonary Fibrosis Foundation (PFF) envisioned a new approach to aggregating usable medical data — asking patients directly.
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3 Tips For Selecting Your eTMF Platform
Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.
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2 Ways To Encourage Clinical Trial Investor Funding
Consider these two promising funding models that balance risk with reward: trial-specific fundraising and staged funding release.
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The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials
Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.
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Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov
The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting of trial results.
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Is Ignoring Gender Non-Conformity Research Holding Us Back?
Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.
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Tokenism In Clinical Trials For Rare Disease Patients
While recent efforts promote diversity in clinical trials, the lack of enforcement and tokenistic approaches risk leaving people of color behind. This article delves into the urgency of addressing this crisis and building genuine inclusivity for a healthier future for all.
CLINICAL TRIAL WHITE PAPERS
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How eConsent Is Changing The Informed Consent Process
Learn how informed consent — providing a potential participant with enough information about a study to allow for an informed decision about their participation — is a critical step for enrolling patients in clinical trials.
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Mobile Application Considerations For Clinical Trials And Beyond8/28/2023
Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.
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HIV – Global Clinical Trial Landscape1/3/2024
Get a comprehensive overview of the global HIV clinical trial landscape since 2018, showcasing regional leadership, trial phases, and growth rates.
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How Can Digital Measures Advance Heart Failure Research?2/27/2024
Wearable DHTs offer a less burdensome means of collecting data on physical activity, mobility, and sleep patterns, all of which are crucial indicators in heart failure management.
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Cultivating A Bespoke Recruitment Strategy For Your FSP Partnership12/1/2023
Pharmaceutical organizations and service providers employ diverse recruitment strategies. Explore how a multifaceted approach to staff recruitment can greatly speed up clinical trial success.
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Developing A Data Strategy For Clinical Trials9/20/2023
This white paper outlines a standardized method for developing a data strategy that can be tailored to a company's current needs and adapted as those needs evolve.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Imunon Phase IB Ovarian Cancer Study Shows Strong Progression-Free Survival Treatment Effect Using A Synthetic Control Arm12/8/2022
Explore how Imunon used a control arm among stage III/IV ovarian cancer patients in their clinical trial.
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Study Launches Early Phase In Australia With Later Expansion To China5/8/2023
Understand how a biotech company was able to facilitate clinical development plans to extend its study into China for Phase II component, as quickly as possible.
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How NetSuite And Coupa Integration Helps Biotech Companies Streamline Processes And Manage Growth1/30/2023
Discover how a therapeutics company began the search for a business spend management solution that would automate everything from procurement to payments and integrate seamlessly with a new ERP.
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Sole-Provider FSP Model Beats Schedule, Exceeds Expectations11/22/2023
See how this tight collaboration resulted in the swift acquisition of staffing at levels beyond initial expectations and propelled advancements in processes across a spectrum of workstreams.
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Breakthrough Therapy Designation Accelerates Oncology Treatment Development10/24/2023
Find out how this evidence-generation company's solutions and scientific expertise enabled early and successful regulatory submission for a novel oncology therapeutic.
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Study Completes Recruitment, Overcomes Pandemic Hurdles9/6/2023
Amid challenges during the COVID-19 pandemic, discover how recruitment was completed in three countries for a Sweden-based pharmaceutical company's phase 2b study.
NEWSLETTER ARCHIVE
- 03.18.24 -- Site Feasibility Tips For Cell And Gene Therapy Clinical Trials
- 03.15.24 -- How RBQM Has Evolved In Recent Years
- 03.15.24 -- Partners Serving Solutions For Patients And Sites
- 03.14.24 -- Taking Psychedelic Trials To Australia
- 03.14.24 -- Equitable Trials: Navigating Diversity In Clinical Research
CLINICAL LEADER CONTENT COLLECTIONS
With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.
More Content CollectionsFOCUS ON PATIENTS
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Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.
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Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.
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While recent efforts promote diversity in clinical trials, the lack of enforcement and tokenistic approaches risk leaving people of color behind. This article delves into the urgency of addressing this crisis and building genuine inclusivity for a healthier future for all.
EMBRACING DIVERSITY & INCLUSION
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Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
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The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
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The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.