New techniques are not only proving to be more effective than animal testing but will herald a completely new way of investigating novel treatments. Using these techniques, like human chip models, medical researchers will be able to actually run “clinical trials” before testing a drug in live humans.
- Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act
- Remote Candidate Fraud In Clinical Research: A Cautionary Tale For Interviewers
- Reflecting On The Syneos Health Acquisition: The Due Diligence Imperative
- From Big Pharma To Nonprofit: 3 Learnings In Building Biostatistics++ Teams
- Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs)
- FDA Releases Draft Guidance On Decentralized Clinical Trials
- Patient-Powered AI Is Driving Science And Innovation Forward
GUEST COLUMNISTS
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FDA Releases Draft Guidance On Decentralized Clinical Trials
The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.
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Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs)
When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.
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Patient-Powered AI Is Driving Science And Innovation Forward
Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance.
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FDA’s Digital Health Technologies Framework Addresses Important Challenges
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.
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Phase 1 Strategies To Optimize Orphan Drug Development
While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy.
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Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials
The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.
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Advancing Innovative Therapies For Mild-To-Moderate Psoriasis With Novel PASI-HD Assessment
The Psoriasis Area and Severity Index, or PASI, was developed in the 1970s as a tool for assessing the severity of psoriatic lesions for the purpose of assessing outcomes in a psoriasis clinical development program. But it falls short in assessing the severity of the disease in those wild mild to moderate psoriasis. Enter PASI-HD.
CLINICAL TRIAL WHITE PAPERS
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Objective Scratch Assessments Using Digital Health Technologies (DHTs)
This white paper explores how an objective scratch measure is now achievable through the use of wrist-worn wearable technology that is both non-invasive and easy to implement.
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2020 Completed Trials: A Bumpy Road for Industry-Sponsored Clinical Studies9/27/2021
The COVID-19 pandemic created delays for trials that were planned for completion in 2020 and directly contributed towards trial terminations. Despite this, more diseases, and more indications outside of oncology, achieved at least 25 successful trials. Read the full report.
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Measuring The COVID Effect On Clinical Trials7/18/2022
From making sites inaccessible to the unprecedented development of vaccines, COVID-19 has permanently changed the nature of clinical research. This white paper assesses how well industry R&D has performed and what, if any, lessons have been learned.
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Making Clinical Research Better For Patients With Patient Centricity By Design10/17/2022
Discover why many sponsors struggle to design and conduct studies that accommodate the perspectives and preferences of patients and caregivers.
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eSource: The Evolution Of Clinical Trial Data Capture, Monitoring, And Management1/17/2023
Learn about the rapid rise of eSource and how it is quickly displacing traditional paper-based data sources.
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Vendor Management And Oversight Of Clinical Trials8/9/2021
Vendor management and oversight of clinical trials continues to be a critical activity for sponsor companies planning and conducting clinical trials. Read how vendor management and oversight is not only a regulatory imperative, it is also a business imperative.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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One Platform Provides A Single Source Of Truth For Quanticate9/14/2021
Read how one of the world’s largest biometric CROs and data specialist, Quanticate, combines the latest technology and trusted relationships to ensure the highest data quality results throughout a trial’s lifecycle.
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Maximizing Oncology Study Outcomes: Overcoming Enrollment Challenges In A Phase 2 Prostate Cancer Clinical Trial5/5/2022
Dive into this case study to see how a U.S.-based developer of an investigative therapy for mCRPC was able to increase enrollment in a Phase 2 mCRPC study involving 100 patients at six sites in the United States.
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How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic11/3/2021
A leading Eastern European contract research organization, successfully completed the recruitment of 236 subjects in a Phase III osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.
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How Remote Site Access Is Changing Clinical Operations11/2/2021
How can always-on remote site access benefit your research organization? Read about these benefits and the importance of reliable, efficient remote site access.
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High-Profile Vaccine Study Involves eCOA Provider Collaboration3/30/2023
Learn how researchers were able to effectively collect payments, drive engagements, and present value to the sponsor, sites, and patients.
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EU Set To Attract More Clinical Trials With Streamlined Submission Process8/25/2021
Patients can be assured that their prescribed medicine has been vetted for safety and efficacy by a long and arduous discovery process guided by governmental regulatory agencies. The European Union (EU) recorded a concerning 25% decrease in clinical trial applications (CTAs) from 2007 to 2011, and this downward trend has continued. Find out why.
NEWSLETTER ARCHIVE
- 05.26.23 -- Data Collection & Management Considerations For Decentralized Trials
- 05.26.23 -- Make Your Clinical Trial Process More Efficient With Software And Services
- 05.25.23 -- Astellas Exec: Responding To A Clinical Hold
- 05.25.23 -- A Flexible, Cost-Efficient Way To Manage Clinical Trials Around The Globe
- 05.24.23 -- FDA Releases Draft Guidance On Decentralized Clinical Trials
CLINICAL LEADER CONTENT COLLECTIONS

In this e-book from Clinical Leader, experts from sponsors and professional organizations, as well as our own chief editor, Ed Miseta, delve into the challenges experienced by sites and offer ways in which sponsors can strengthen relationships with them, and thereby their patients.
More Content CollectionsFOCUS ON PATIENTS
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Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance.
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The Psoriasis Area and Severity Index, or PASI, was developed in the 1970s as a tool for assessing the severity of psoriatic lesions for the purpose of assessing outcomes in a psoriasis clinical development program. But it falls short in assessing the severity of the disease in those wild mild to moderate psoriasis. Enter PASI-HD.
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Incorporating patients into every step of the process is integral to overcoming obstacles related to clinical development of rare disease treatments. Obtaining early patient input, designing meaningful clinical trials, and considering manufacturing strategy early is crucial.
EMBRACING DIVERSITY & INCLUSION
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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.
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Overcoming the diversity gap in clinical trial research requires multilevel approaches and collaborative partnerships. Genentech's Alekhya Pochiraju reveals four easy ways sponsors can together with their site sites foster more patient diversity and shows us the importance of prioritizing diversity at the program and portfolio level.