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Home » Authors » Leslie Ramsey

Leslie Ramsey

Articles

ARTICLES

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Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

November 24, 2019
Leslie Ramsey
The ability of sponsors and CROs to meet the needs of their sites has improved slightly in recent years, according to a new CenterWatch survey, but sites say they need to see more progress in almost all aspects of their working relationships. Read More
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ICH Overhauls 22-Year-Old Clinical Studies Guideline

November 24, 2019
Leslie Ramsey and Colin Stoecker
For the first time in 22 years, the International Council on Harmonization (ICH) is almost completely overhauling the guideline ICH E8 — General Considerations for Clinical Studies, the international standard for designing and developing trials. Read More
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Building a Site of Choice: Advice from the Field

October 14, 2019
Leslie Ramsey

What does a site need to do to trim its study start-up timeline from several weeks down to just a few days?

Panelists from various site organizations shared their secrets to rapid start-up and other best practices at MAGI’s “Be the Site of Choice” conference in Philadelphia last week.

Read More
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2018 Trial Starts Up Over Previous Year

October 1, 2019
Leslie Ramsey and Colin Stoecker

The number of new trials rose in 2018, but sponsor investment in research and development remained steady, a new survey shows.

Phase 1 through phase 3 trial starts rose 12 percent in 2018 to 7,606, up from 6,794 in 2017, according to an Informa survey. Phase 1 starts totaled 2,900, up 3 percent, while phase 2 fell 4 percent to 2,469. Phase 3 trials held their ground with 1,373, less than a 1 percent increase.

Read More

Protocol Problems Continue to Trip Up Investigators, FDA Data Show

September 23, 2019
Leslie Ramsey

The most pressing compliance problem clinical trials have, data from the FDA show, continues to be following their protocols to the letter.

The agency’s report on inspection findings in fiscal year 2019 places “failure to follow investigational plan” at the top of the list of most frequently cited observations, a spot it has held for the past five years. But the numbers are dropping, from 171 citations in 2015 to 108 in inspections conducted in 2019.

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Human Experience, Analytical Systems Join to Strengthen Trials

August 12, 2019
Leslie Ramsey

Drawing objective conclusions from subjective measurements is a common challenge in pain management research and one that can lead to skewed results without a system to analyze data, spot problems and evaluate their impact.

But identifying aberrations is not the only challenge, says Arturo Morales, chief technology and data officer for WCG Analgesic Solutions. “It’s very easy to tell that one thing is not like the others. But merely looking at data and saying, ‘This one looks different,’ describes the way people have been approaching monitoring in clinical trials for years.”

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FDA, ICH Seek Comments on “Quality by Design” Draft Guideline

August 5, 2019
James Miessler and Leslie Ramsey

Sponsors, CROs and other stakeholders have until September 30 to help shape a critical trial design guideline, according to the FDA’s call for public comment on the revision of ICH E8 last week.

The ICH E8 revision is the latest step in the International Council on Harmonisation’s (ICH) efforts to update trial standards, following the revision of ICH E6 — Good Clinical Practices in 2016.

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Easy Document Access Key to Inspection Success, Expert Says

July 29, 2019
Leslie Ramsey

When the FDA shows up with inspection notice in hand, will you be able to produce the documents they request quickly and efficiently? Knowing where all your records are stored and what condition they are in is vital to inspection success, says one former FDA district director.

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Reduce Risk, Increase Efficiency by Centralizing Site Operations, Experts Say

June 24, 2019
Leslie Ramsey
As clinical trial administrative tasks become more burdensome and technologies more complex, research professionals are spending more time on the business of trials than on the science. To maximize potential, academic research institutions, hospitals and other large organizations should bring all trial management and finance functions into one centralized operations hub. Read More

Broaden Criteria to Maximize Trial Results, FDA Says

June 10, 2019
Leslie Ramsey
Sponsors should think about loosening their exclusion criteria to allow more diverse patient populations—especially when recruiting for later stage trials, the FDA says in new draft guidance published last week. Read More
View All Articles by Leslie Ramsey

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