A Closing Thought

Articles

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.

Drug Development in Wartime: Driving Tomorrow's R&D Decisions with Today's COVID-19 Data

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

Pandemic Highlights Urgency for New Methodologies for Evidence Generation

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

Data Management Landscape is Still Changing, Are We Adapting Fast Enough?

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


How Organizations Can Put Sites First When Implementing New Trial Technology

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

Predicting the Probability of Success in Clinical Drug Development

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?

Relying on Data and Behavior Science to Unlock Real Change

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.

Non-Data Scientists: The Evolving Role of Clinical Data Management

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

The Rise of Shared Digital Health Economy and Promise of Accelerated Clinical Research

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.

Patients as Partners in the API Era

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

Closer Pharma-Diagnostic Collaboration is Key to Alzheimer’s Drug R&D

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

How to Avoid Common Pitfalls of Market Landscaping

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

Ensuring High-Quality Data in Complex, In-Home Clinical Trials

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

Any Cancer Can Be a 'Rare Cancer'

Lori Goldberg is CEO, Silverlight Digital

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.  

Finding Patient X: The Role of Digital Media in Rare Disease Research

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.

Dermatology Biologics: Overcoming Challenges to Fulfill Therapeutic Potential

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.

How Does Shinal v. Toms Affect Informed Consent in Pennsylvania Clinical Trials?

Rolf Ehrhardt, MD, PhD is CEO of MedCision.

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

The Success of Cell Therapies Will Depend on Automation

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.

The Productivity Opportunity that Biopharma is Missing

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. 

Four Axioms That Will Always Explain Successful Clinical Performance

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