Posts tagged with 'clinical'
Study Shows Minorities Underrepresented In Vaccine TrialsRead the rest of this entry »
Vaccine trials underrepresent large segments of the population, while women are overrepresented, says a study published recently on the JAMA Network Open.
“In this cross-sectional study of 230 US-based clinical trials with 219,555 participants, Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented and women were overrepresented compared with the US population,” the research study authors wrote.
Equally significant was the …
Here’s How to Land That First Clinical Research JobRead the rest of this entry »
Starting a career in clinical research is challenging. Armed with a relevant college degree, an internship or two and even with a certificate in clinical management, landing an entry-level job isn’t easy.
Says Kunal Sampat, MNA, ACRP-CP and host of the Clinical Trial Podcast, “Employers want applicants to have relevant CRA experience.”
That’s the old chicken and egg dilemma: How do you get the experience without having a job and …
New Group Will Promote Decentralized Clinical TrialsRead the rest of this entry »
Several of the world’s healthcare, bioscience and pharmaceutical firms, including such global leaders as AstraZeneca, Pfizer and Biogen have joined together to accelerate the adoption of decentralized clinical trials and research.
In the planning stage before the coronavirus pandemic, the Decentralized Trials & Research Alliance (DTRA) formally announced its founding this month. With an initial membership of some 50 organizations, the alliance declared its mission to “make clinical trial participation …
Clinical Investigators Need to Know the Privacy RulesRead the rest of this entry »
Distracted by the COVID pandemic, clinical investigator sites that haven’t been paying attention to new privacy laws may find it difficult to conduct trials in 2021.
“Nine out of ten investigator sites in the U.S. don’t know anywhere near enough,” and “don’t have the right tools to be in compliance,” says an article on the Association Of Clinical Research Professionals blog.
An interview with Al O. Pacino II, president …
Career Advice From Clinical Research ProsRead the rest of this entry »
In an industry with many roles, seek out the one you love, the one where your passion lies.
That's good job advice for all seasons and all professions, but in this it refers to finding your niche in clinical research.
It's among a wealth of career advice from industry veterans, published in two parts this month on the ACRP’s Clinical Researcher site. These professionals describe their own career journey, offering …
Lies and Deceit Plague Clinical TrialsRead the rest of this entry »
The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.
Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional …
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 …