Posts tagged with 'clinical'
COVID Trials Raising Awareness of Clinical DiversityRead the rest of this entry »
Minority representation in clinical trials is an issue the coronavirus vaccine trials has brought out of medical publications and journals and into the broader media.
“If Black people have been the victims of COVID-19, we’re going to …
Is It the Drug Or Fitbit Making the Difference?Read the rest of this entry »
As if clinical researchers and managers didn’t already have enough to worry about, now add activity trackers to the list.
Smartwatches, Fitbits and similar trackers have the potential to influence behavior, which matters in studies where physical activity is a study endpoint. (An endpoint in a clinical study is an event used to objectively measure the effect of a drug or other intervention.)
If the level of activity is an …
Virtual Clinical Trials Could Become the New NormalRead the rest of this entry »
Since Pfizer launched the first randomized clinical trial to be conducted entirely remotely in 2011, virtual clinical trials have been a trend waiting to happen. Now, prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.
Writing in the May DIA Global Forum, Dr. Jonathan Cotliar, says that with the impact COVID-19 is having on traditional, face-to-face trials, “Those …
COVID-19 Puts Spotlight On Adaptive Clinical TrialsRead the rest of this entry »
One of the lasting effects of the COVID-19 pandemic is likely to be the accelerated acceptance of adaptive clinical trials.
Dr. Anthony Fauci endorsed adaptive trials when he announced the effectiveness of remdesivir in treating COVID-19 patients.
“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover," Fauci said in a White House briefing April 29.
The data came from a unique type …
COVID-19 Is Prompting Innovation In Research TrialsRead the rest of this entry »
As scientists race to develop a vaccine and cure for the coronavirus that causes COVID-19, a remarkable collaboration has emerged among pharmaceutical and bioscience firms that in other times compete fiercely with each other.
Promoted by the Bill and Melinda Gates Foundation weeks before the virus was declared a pandemic, the initial 15 companies -- Novartis, Bristol-Myers Squibb, Eli Lilly and Gilead among them -- began sharing proprietary information about …
Clinical Research Hit By High TurnoverRead the rest of this entry »
Clinical research associates in the US are leaving jobs at the rate of 30% a year, says a new report from the consulting, tax and advisory firm, BDO.
Where turnover rates for these clinical monitoring professionals had been holding steady at 25%, the rate jumped between 2017 and 2018 by 4%. Outside the US, the global average is a modest 16%.
Turnover has plagued clinical / contract research organizations (CROs) …
How Big Is the Right Size For a Clinical Trial?Read the rest of this entry »
When a drug company embarks on a clinical trial, one of the risks it runs is the nonadherence of participants to the rules. In simplest terms, that means if a patient is to take a pill in the morning and another at night, deviating from the schedule is nonadherence. If too many participants deviate, the trial could fail.
An article in Applied Clinical Trials discusses the statistical implications of nonadherence. …
Survey: Clinical Trials Are Important, But Hard to FindRead the rest of this entry »
A global survey of attitudes and perceptions about clinical research trials found both the public and those who have participated in a trial convinced of their importance, but lacking in understanding about how they work and largely uninformed about opportunities for participation.
Conducted by the Center for Information and Study on Clinical Research Participation and published last week on JAMA Network Open, the purpose of the survey was to …
Millennials Are Putting Traditional Clinical Trial Model At RiskRead the rest of this entry »
Millennials have been accused of disrupting practically everything including credit cards and shopping malls. But until this spring, no one's accused them of putting the entire clinical trial model at risk.
But that's just what Kent Thoelke did. "Health care delivery and the technology adoption in health care delivery is already surpassing anything we do in drug development," he said, speaking at the inaugural event of the Bridging Clinical …
Online 'Listening' Is Improving Clinical Trial DesignRead the rest of this entry »
As companies strive to make their clinical trials more patient-centric, monitoring social media discussions is becoming an important tool to learn what matters to patients, their families and caregivers.
An article in Applied Clinical Trials says that by listening to what's being said in online forums trial designers and managers can gain insights they can incorporate to make their program more accommodating to their concerns. "Patient stories capture what it …