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
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
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.
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.
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.”
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.
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
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