An updated protocol writing tool developed by NIH and TransCelerate aims to help the clinical trials industry write better protocols. While it won’t necessarily help the clarity of writing, it does lay out a template to help guide the work.
Currently, 2,400 active users are developing protocols with the help of NIH’s e-Protocol Writer, an online tool that walks teams of investigators through protocol development, making sure they apply scientific standards required by NIH and the FDA as well as standards of good clinical practice, such as ICH E6 and E8.
Some daunting statistics from the last decade: 38 percent of phase 3 trials failed; 59 percent of trials did not advance from phase 1 to phase 2 and 35 percent of trials entering phase 2 did not move to phase 3.
“Most drugs are in clinical phases for five to seven years,” said Ken Getz, director of sponsored research programs at the Tufts Center for the Study of Drug Development. “This is extremely costly — but not easy to calculate since it includes the cost of all phase 1, 2 and 3 activity. ... The typical drug costs several hundred million dollars in direct costs to carry through all clinical testing phases.”
The FDA yesterday proposed broadening its definition of the standard of evidence for effectiveness of investigational drugs and increasing the range of acceptable trial design, especially in rare disease research. Read More
A new survey on diversity in clinical trials found that older people are more likely to be asked by their doctors to participate in a clinical trial than their younger counterparts. More than half of older patients were asked by their doctor to participate in a clinical trial compared to 30 percent of patients 34 years or younger. Read More
As the use of commercial apps in clinical trials mushrooms, sites will need to work more closely with their IRBs to be sure using those apps doesn’t slow down a trial. Read More
For the second year in a row Novartis has been named the most innovative pharma company in the industry by the Innovation Index, a collaboration between CNS Summit and IDEA Pharma.
“The differentiator between Novartis and the competition was the nature of these innovative initiatives, which showed strong potential to be transformative, rather than incremental,” said a report on the index, which measures companies’ advances in trial optimization, clinical innovation and use of digital technology.
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 following summary of CenterWatch’s 2019 Global Site Relationship Survey presents sites’ views on the CROs they work with. In last month’s issue, we provided details on their sponsor relationship views, as well as data on the types, locations and therapeutic areas of the site responding to the survey (CenterWatch Monthly, November 2019).
Sites are looking for improvements in almost all areas of their working relationships with CROs, but particularly in the areas of contracting and budget, according to a new CenterWatch survey.
