Research & Development: Page 33
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PharmaVoice Team/PharmaVoice
Best Practices in Long-Term Safety Follow-Up Studies in Oncology
As the quest to develop more effective treatments for cancer continues, a growing number of therapies are receiving accelerated approval from the U.S. Food and Drug Administration (FDA).1 The percentage of new oncology drugs that have gone through the Accelerated Approval Program increased approx...
By Jane Bentley • March 1, 2021 -
PharmaVoice Team/PharmaVoice
Speak Out: Making Your Trial Break Through: How Imaging Can Make — or Break — Your Accelerated Trial
Breakthrough Therapy studies evaluate the effects of therapies on the most severe diseases, where patients have irreversible morbidity or mortality [IMM] or symptoms that represent serious outcomes of their sickness. The pressure to deliver quality data is immense because the cost of not deliveri...
By Peter Steiger • March 1, 2021 -
Explore the Trendline➔
Stock via Getty Images
TrendlineClinical trial diversity
As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Celebrating firsts… Last month we witnessed Kamala Harris sworn in as the first woman, Black, and South Asian American as the 49th Vice President of the United States by Supreme Court Justice Sonia Sotomayor, the first Latina to be named to the bench and just the third woman to be named to the hi...
By Taren Grom • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
SHOWCASE: Decentralized Clinical Trials: Building a Collaborative Alliance for Decentralized Trials
When COVID-19 forced clinical trials across the world to shut down due to the risk it posed to patients and an overloaded healthcare system, it brought decentralized trials to the fore. Decentralized clinical trials (DCTs) have been gaining impetus for several years, supported by mobile technolog...
By PharmaVoice Team • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Decentralized Clinical Trials (DCTs): Five Key Questions to Ask Your Partners to Optimize Strategy
Anyone who has ever had a child with a suspicious sore throat or rash has considered the convenience of getting a diagnosis over the phone. But they know that as soon as they call the doctor’s office, they are going to have to get in the car and drive to a face-to-face appointment. Until now. COV...
By Donna Hanson • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Decentralized, Hybrid or Traditional: Choosing the Best Option for Your Clinical Trial
While elements of decentralized and hybrid trials existed prior to the coronavirus pandemic, the ongoing crisis accelerated the demand for an alternative to the traditional, on-site model as the pharmaceutical industry was focused on managing patient safety and ensuring data integrity for COVID-1...
By EB McLindon • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
DCTs Are Our Genie in the Bottle
Global events often trigger cultural disruptions that forever change the way we work. In World War II, Rosie the Riveter inspired 19 million women to enter the workforce to cover for the men at war. Economists thought it would be a temporary fix, but when the war ended women kept working, changin...
By Josh Rose • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Clinical's Crystal Ball: How the Decentralized Model Will Transform Patient Care
It is 2022 – welcome to a new era of healthcare, where patients are No. 1. With this phrasing, you may envision a football game of healthcare with rowdy fans waving foam fingers in the air, chanting boisterous incantations of support for Team Patient. Of course, this is not a game but rather the ...
By Alison Holland • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
A Paradigm Shift Towards Better Healthcare for All
The world and technology are racing ahead of the clinical trials industry. Digital health technologies (DHTs) continue to advance while clinical research remains slow to embrace efficient technologies and offerings that are widely being deployed in healthcare. The result is a market where a new m...
By Isaac Rodriguez-Chavez • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Will Decentralized Trials Finally Drive Meaningful Drug Development? Transformation?
Our industry has come a long way since the early days of clinical research. However, as time goes on clinical trials are becoming more complex, and if these complexities aren’t well managed patients bear the burden. When patients sign up to participate in a clinical study, they’re placing tremend...
By Maria Fotiu • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Commanders & Chiefs: Clinical Services C-Suite
CROs and other clinical services companies have positioned themselves to be valued partners to biopharma companies. The executives of these companies are charged with not only setting the strategic direction for their organization but setting the pace for innovation to make the clinical trial pro...
By PharmaVoice Team • Feb. 1, 2021 -
PharmaVoice Team/PharmaVoice
Upfront
DTRA Launches to Democratize and Accelerate Clinical Trials A new global industry coalition — Decentralized Trials & Research Alliance (DTRA) — aims to dramatically increase access for all patient populations in clinical trials and research. DTRA’s goal is to unite stakeholders, including hea...
By PharmaVoice Team • Jan. 1, 2021 -
PharmaVoice Team/PharmaVoice
Upfront
#NoGoingBack Almost three dozen signatory companies collaborated to form the #NoGoingBack movement, which is committed to continuing the progress made in clinical research during the COVID-19 pandemic. According to the movement, the industry has learned bold new ways to conduct trials due to COVI...
By PharmaVoice Team • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
HealthTech
Tiny Robots Tumble Through Organs to Deliver Drugs Trend Watch: From patient rides to telehealth specialty visits, healthtech continues to forge new paths for better patient outcomes. Tiny Robots Walk Through Colon to Deliver Drugs, Sample Tissue A rectangular robot as tiny as a few human hairs c...
By PharmaVoice Team • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
2021 Year in Preview: The Year to Come and the Year That Was
Who knew? 2020 will be defined as one of the most tumultuous years in history: a global pandemic and civil strife giving way to innovation and greater collaboration. Even as COVID-19 vaccines make their way through safety trials and treatments receive expedited review and approval, the 2021 cryst...
By Taren Grom • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
SHOWCASE: Technology Solutions: Disrupting Innovation with Digital Solutions
Healthcare is undergoing a massive transformation with increased emphasis on digital technologies in all areas. According to Deloitte research, biopharma companies recognize that digital transformation will aid product and service innovation, greater customer engagement, and improvements across R...
By PharmaVoice Team • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Virtual Trials: Navigating Change and Avoiding Blinds Spots
As 2020 draws to a close, we reflect on the changes we have had to make in all facets of our lives due to the pandemic. Some were overdue and some are here to stay. Some were easy to adopt and others we resisted. Change of any sort, positive or negative, is known to be one of life’s great stresso...
By Kenneth G. Faulkner • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Four Ways Predictive Analytics Can Strengthen Your Commercialization Efforts
Over the past few years, artificial intelligence (AI) and machine learning (ML) have been trending topics in healthcare but are now being propelled to the forefront of clinical decision support and care delivery. Some organizations, however, have been slow to adopt the utilization of predictive a...
By Steve Mack • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
A New Framework for Improving Brand Performance
Why Managing Brand Performance is So Challenging Brand performance appears to be a straightforward concept to understand. However, the reality is that within pharmaceutical organizations, each business function has its own perspective of how brand performance should be planned for, monitored, and...
By Pankaj Gupta • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Telehealth: Ready or Not — <del>Here it Comes</del>… It's Here to Stay
Our world is changing more rapidly than ever before, but certain constants remain imperative in the healthcare arena — human connection and access to education. Healthcare professionals (HCPs) need to be able to connect with their patients to properly assess their conditions. HCPs need access to ...
By Christine Molbury • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
The Next Chapter for Real World Evidence: Validating Data with the Patient Voice
In June 2020, in accordance with the 21st Century Cures Act of 2016 and the Prescription Drug User Fee Act (PDUFA), the U.S. Food and Drug Administration (FDA) launched Project Patient Voice. This patient-focused drug development initiative facilitates systematic approaches to collecting and usin...
By Ramita Tandon • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
COVID-19: Silver Linings
COVID-19 has stretched our industry to adjust to all types of new “normals," yet amid all of the disruption and loss of life, there are pockets of light that are expected to lift the life sciences and its people to new heights. Of all the industries that have been impacted across the globe, the l...
By Taren Grom • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Expanding the Spectrum of Clinical Trials
In recent years, pharma and biotech companies have become more aware of the lack of representation of certain demographics in clinical trials and its resulting ramifications. Although the participation of women in clinical trials has improved in recent years, the participation of racial and ethni...
By Carolyn Gretton • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Centering on the Patient by Decentralizing Clinical Trials
When it comes to decentralizing clinical trials, what was long a cracked door has been flung open wide by the COVID-19 pandemic. With COVID-19 sparking major upheaval in clinical trial execution, sponsors, CROs, and other supporters of drug development have been forced to adopt tools long used in...
By Carolyn Gretton • Nov. 16, 2020 -
PharmaVoice Team/PharmaVoice
Health Consumerism on the Rise
COVID-19 has pushed the promise of healthcare consumerism into the open, creating a space where patients have a real voice in their healthcare decisions. The healthcare consumer of the future is arriving faster than anticipated, fueled by the COVID-19 pandemic. Health consumerism, which was begin...
By Robin Robinson • Nov. 16, 2020
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