Due to the vast influx of technology and the advent of Risk-Based Monitoring, the clinical research landscape is now evolving fast, and along with it, so are jobs in the field.

Sites and sponsors should have a lot of leeway in determining how to measure patient experiences during drug development, but researchers should take care that whatever sampling methods they provide are a fair representation of that target population, the FDA said in a new draft guidance issued June 12.

The New England Journal of Medicine has retracted five separate papers and reissued a sixth with corrections, nearly a year after an anesthesiologist raised public questions about whether the volunteers in each of the studies had truly been randomly assigned to different treatments. British anesthesiologist, JB Carlisle, built a computer model that helped him analyze sampling in clinical trials. After examining nearly 5,100 trials, he claimed that two percent of them had used nonrandom sampling when researchers claimed the opposite. Carlisle flagged studies in eight journals, 11 of them having been published in the New England Journal. On June 13, the Journal announced that it was retracting five of those studies. A sixth — a 2013 study on the benefits of the Mediterranean diet — was retracted but republished after researchers “reanalyzed” their data.

GT Biopharma announced preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase I/II trial for patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase I/II trial. The trial has two arms including patients diagnosed with relapsed/refractory B-cell lymphomas (NHL) and leukemias (ALL). 18 patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. At the interim review more than 50 percent of patients (seven of 13) exhibited a clinical benefit, defined as stable disease plus partial response or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial response (PR) and five demonstrated stable disease (SD). The efficacy signal was most prominent in ALL patients with 75 percent (three of four) exhibiting clinical benefit including one CR, one PR and one SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

Patients overwhelmingly feel that the benefits of clinical trials outweigh the risks to their personal privacy, according to a new study in the New England Journal of Medicine.

A new reorganization at the FDA’s Center for Drug Evaluation and Research will assign multidisciplinary teams to work on new drug applications from the beginning of the regulatory process, will centralize project management under the Office of New Drugs, and increase the number of offices overseeing review divisions from five to nine and increasing the overall number of review divisions from 19 to 30, the agency announced June 4.

eConsent has developed a reputation for being the next big technological innovation in clinical trials, and adoption efforts are accelerating.

HHS will publish its semi-annual regulatory agenda on Monday, and it includes a February 21, 2019, effective date for a new rule that will require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. The agency’s final rule applies to data intended to support IDE applications, 510(k) submissions, and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens. The new mandates would replace the current pre-market approval regulations that require clinical studies to conform to the Declaration of Helsinki or the law of the country where the research is conducted, whichever carries greater protection for human subjects, the FDA said. The rule does not apply to all clinical investigations performed overseas, but only sets criteria for FDA acceptance of data used to support device marketing applications or submissions.