Posts tagged with 'clinical'
How to Write a Clinical Study ReportRead the rest of this entry »
If you’re new to clinical research, or even if you’re not, sooner or later you'll be tasked with authoring a clinical study report.
These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.
“A clinical study report (or CSR for short),” explains Eli Lilly in a …
How COVID Is Changing Clinical TrialsRead the rest of this entry »
Amidst all the uncertainty about a COVID vaccine, at least this one thing is certain: it is changing how clinical trials are conducted.
Instead of taking years to move a potential vaccine from laboratory to trial, the US’s Operation Warp Speed has moved two of six prospective COVID vaccines into Phase 3 recruitment in under six months. Two more are expected to begin Phase 3 recruitment this month.
In the …
Rare Diseases Trial Network Moves Closer to RealityRead the rest of this entry »
As many as 30 million Americans may be living with a “rare disease,” officially defined as a condition affecting fewer than 200,000 people.
The Genetic and Rare Diseases Information Center says there are some 7,000 known rare diseases. Most are genetic. Only about 10% of all rare diseases have an approved treatment.
To hasten the development of drugs and therapies, the Food and Drug Administration in 2019 began an initiative …
Technology Is Transforming the Clinical Research WorkforceRead the rest of this entry »
The clinical research workforce is facing a transformation brought about by the rapid changes in how clinical trials are conducted.
New roles are already emerging, while traditional roles are evolving as decentralization and the technology to support the trend require new skills to effectively manage a trial where researchers and patient may rarely, if ever, meet in person.
A new whitepaper from the Association of Clinical Research Professionals details these …
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) …