ARTICLES BY ED MISETA
ISR Projects Growth In eTMF Market
In December 2019, ISR Reports released the 2nd edition of its eTMF Market and Service Provider Dynamics report. The 118-page report collected data from 110 respondents who worked for sponsor companies and CROs and who had direct, recent experience with eTMF software systems.
Technology Advancements Spur Adoption Of Virtual Trials
Patient recruitment and retention in clinical trials has long been an issue for pharma companies. This results in many trials being delayed and even canceled. One recent advancement that could help with both recruitment and retention is virtual (decentralized) trials.
Teva Develops First FDA-Approved Digitally-Integrated Inhaler
Two challenges have plagued asthma sufferers and researchers for year. The first is patients not adhering to their maintenance medication. The other is patients not using proper inhaler technique. A new digitally-integrated inhaler from Teva hopes to eliminate both problems.
Patient Diversity Starts With Community Connections
When it comes to clinical trials, the pharmaceutical industry still has a patient diversity problem. The face of patients in clinical trials is not representative of the face of America or the individuals projected to be most in need of the medications being developed.
Janssen Uses Geofencing To Monitor Clinical Trial Patients
A new patient-facing technology being tested by Janssen will be used to passively track hospitalization events based on the location services available from the smartphone of a patient.
Master Trial Protocols: Better For Pharma, Better For Sites
Over the last few years there have been increased discussions in the industry around a master protocol approach to clinical trials. Those discussions have really accelerated over the past year, spurred on by the FDA, which in September 2018 released draft guidelines on this topic for the industry.
BMS-Pfizer Alliance Evaluates AFib Screening And Stroke Connection
In November 2019, the BMS-Pfizer Alliance announced the initiation of a new randomized, controlled study called GUARD-AF. The trial will evaluate whether atrial fibrillation (AFib) screening can ultimately impact the rate of stroke, compared to standard medical care in older individuals in a real-world setting.
Acquiring And Implementing Innovation In The Pharmaceutical Industry
Pravin Jadhav has spent his entire career in the world of drug development. He is currently the Senior Director of Applied Innovation at Otsuka. Jadhav was a featured speaker at the recent CNS Summit in Boca Raton, and we took that opportunity to talk to him about innovation in the pharmaceutical industry, and how companies can best acquire and implement new solutions.
Study Reveals Nearly $215 Billion Economic Burden Of Nocturia
Dr. Jay Jhaveri, lead investigator for Ferring Pharmaceuticals, knew that nocturia was a burden to many patients and to the U.S. economy. Unfortunately, no HEOR existed for nocturia. For that reason, Ferring decided to produce its own. To get the real-world information it needed on the prevalence of the condition, the company turned to the National Health and Nutrition Examination Survey (NHANES).
What Exactly Is A Virtual Clinical Trial?
Oracle Health Sciences and the CNS Summit have released a research report on the use of virtual components (patient-facing technologies) in clinical trials. The findings are the result of focus group interviews and supplementary research with key stakeholders involved with clinical trials.