Columns | A Closing Thought

Trust-based relationships form the foundation for successful trial management.

Jim Kremidas, former executive director, Association of Clinical Research Professionals, shares his experiences as a patient in clinical trials.

Even with exciting advancements, stakeholders must remain diligent in choosing data platforms.

Through grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.

The responsibility of increasing diversity falls on every stakeholder in the clinical trial value chain.

DCTs and RWD among topics for industry to focus on moving into 2023.

Study shows more support is needed for clinical teams to ‘FAIRify’ their data.

Accelerating trends in clinical data are forcing changes in strategy.

COVID spotlights the troubling disparity in clinical research representation. How can we remove these barriers?

How the digital environment can transform drug development space.

The only way for pharma companies to know where to focus their COVID-19 R&D efforts is for the industry to have access to real-time, real-world evidence of what’s working to keep people alive, write Travis Leonardi and William Kirsh.

The need for statisticians, mathematicians, and computer and data scientists to collaborate on modern methods for “substantial evidence” in drug development is critical.

The evolving challenges and new opportunities from the latest wave of change in clinical data management practice.

Organizations that continue to disregard the technological needs of one of the industry’s core audiences run the risk of having their trials ignored.

Undertaking an assessment of the POS can be coupled with the product profile and safety assessments of compounds prior to launching a clinical trial.

What small “nudges” can serve as reminders and relevant motivators to help patients meet their goals, talk to a physician, explore a clinical trial, or stick with a treatment?

The “citizen data scientist” is the person with no official data scientist training who uses the latest tools and technologies to handle data wrangling duties, analyze data, and create reports and models.

Patient advocacy organizations are swaying away from a traditional model of granting academic researchers to now supporting biotechnology and pharma companies.

The availability of FHIR-based APIs enabling patients to access and use their healthcare data for multiple purposes has opened a door to an entirely new world of opportunities for partnering with patients on clinical studies.

Pharma and diagnostics companies need to strengthen alignment in Alzheimer’s disease research-to help turn science and data into actionable medical innovations.

Key tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.

To support complex in-home clinical research and investigative sites, well-designed trials must produce the same high-quality data as traditional sites.

With more common cancers now increasingly broken down by specific genomic defects, the future of research for any cancer is entirely, and unequivocally, molecular.

Digital media is becoming a crucial vehicle for finding “Patient X” for rare disease drug trials. Three areas in particular where digital media is helping with the detective work are explored.

To vie for success in the market for dermatologic therapies, companies developing biologics must navigate a series of significant challenges, including patient compliance and safety.

The ruling by the Pennsylvania Supreme Court requiring informed consent to be obtained by a medical doctor could set a precedent for future nationwide cases involving clinical research.

Automation will be key to improving efficiency and mitigating risk during the complex process of cell therapy production and delivery.

As industry headlines buzz with drug pricing uncertainty and M&A speculation, sponsors can boost productivity on the R&D front through more conscious management of outsourcing spend.

As Applied Clinical Trials celebrates its 25th birthday, longtime contributing author and columnist Ken Getz looks at the four truisms that still drive clinical trial operations today and into the future.

The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.