Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

Continue reading »

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

China has approved its third coronavirus vaccine for the second phase of clinical trials as it reported 12 new COVID-19 cases, taking the total number of infections in the country to 82,816. China has approved three coronavirus vaccines, including the one developed by Chinese military, the People's Liberation Army (PLA) for clinical trials. An "inactivated" vaccine developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology (WIV) started its clinical trials, state-run Xinhua news agency reported.

An "inactivated" vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease producing capacity. In contrast, live vaccines use pathogens that are still alive. WIV has been in the eye of the storm in recent weeks as US President Donald Trump and top American officials alleged that the coronavirus may have escaped from there and demanded a probe into it. An official of the WIV denied it, terming the allegation "entirely based on speculation".

A total of 96 persons in three age groups have received the vaccine in the first phase of clinical trial as of April 23. The vaccine has shown good safety results so far and vaccine receivers are still under observation, said the Chinese pharmaceutical company Sinopharm. The randomised, double-blind and placebo-controlled clinical trials of the inactivated vaccine are conducted in Jiaozuo, central China's Henan Province, and the second phase of clinical trial will focus on the vaccination procedure, it said.

The vaccine will also go through the third phase of the clinical trial, and it may take about one year to complete the clinical trial before finally reaching the conclusion on the vaccine's safety and efficacy, it said. China has approved three COVID-19 vaccine candidates for clinical trials. An adenovirus vector vaccine, developed by Institute of Military Medicine under the Academy of Military Sciences, was the first to be approved to enter a clinical trial. The first phase of the clinical trial was completed at the end of March, and the second phase started on April 12.

Meanwhile China's National Health Commission, (NHC) said on Saturday that 12 newly confirmed COVID-19 cases were reported in the country on Friday, of which 11 were imported. The other one was domestically transmitted in Heilongjiang Province bordering Russia. The death toll in the country remained at 4,632 people as no fatalities were reported due to coronavirus on Friday, it said.

The overall confirmed cases on the mainland had reached 82,816 by Friday, including 838 patients who were still being treated and 77,346 people discharged after treatment. The total number of imported cases of the coronavirus in China increased to 1,629 on Friday, of this 909 had been discharged from hospitals after recovery, and 720 were being treated with 25 in severe conditions, it said. Also on Friday, 29 asymptomatic cases were reported. So far, 983 suspected asymptomatic cases, including 150 from abroad, were still under medical observation, it said.

Coronavirus' first epicentres Hubei and its capital Wuhan had 553 asymptomatic cases under medical observation, state-run Xinhua news agency reported. The asymptomatic cases were a cause of concern as the government has lifted over two-month lockdown in Hubei and Wuhan after cases abated.

Asymptomatic cases refer to people who are tested positive for the coronavirus but develop no symptoms such as fever, cough or sore throat. They are infectious and pose a risk of spreading to others.

Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates.

Mid-Day is now on Telegram. Click here to join our channel (@middayinfomedialtd) and stay updated with the latest news

This story has been sourced from a third party syndicated feed, agencies. Mid-day accepts no responsibility or liability for its dependability, trustworthiness, reliability and data of the text. Mid-day management/mid-day.com reserves the sole right to alter, delete or remove (without notice) the content in its absolute discretion for any reason whatsoever

None of the rats tested at Philadelphia's Wistar Institute contracted Zika after getting the vaccine. It is the best result of a Zika vaccine to date, and it is the same being tested in the first human trials.

“Even after India approves the coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year.”The comments came from the Chairperson of Biocon in an exclusive chat with Business Insider.Syngene, a Biocon subsidiary, is involved in accelerating a bunch of initiatives to develop a vaccine for the novel coronavirus that is spreading around the world.There are at least six vaccines under development in India, of the total 100 around the world including from the likes of Sanofi, Altimmune, and Pfizer. “Indian vaccine programmes will take some time before they get into the clinical trials, I think between 6 to 9 months depending on the programme. At least the ones we are working on, I don’t think they can get to clinics before 9 months,” Kiran Mazumdar

The testing for China's fourth vaccine candidate has started today, said China National Biotec Group. It comes as CDC chief said that China could have its first coronavirus vaccine ready by autumn.

Online Resource

This Viewpoint discusses considerations that might lead physicians to change their practice based on RCTs reporting non–statistically significant differences in primary outcomes, including trial methodology, totality of evidence, cost, invasiveness, and labor-intensiveness of the interventions being compared.

Jennison, Christopher, 1956-

Statement from the National Cancer Institute providing information regarding treatment of cancer patients and participation in clinical trials during the COVID-19 pandemic.

News stories on using pets in clinical trials to test veterinarian drugs, debunking the Piltdown Man once and for all, and deciding just how smart crows can be, with David Grimm.   From the magazine It’s really difficult to figure out how old a free-living animal is. Maybe you can find growth rings in bone or other calcified body parts, but in sharks like the Greenland shark, no such hardened parts exist. Using two different radiocarbon dating approaches, Julius Neilsen and colleagues discovered that the giant Greenland shark may live as long as 400 years.   Read the research.   [Image: James Howard McGregor/Wikimedia Commons/Music: Jeffrey Cook]

The world is facing a pandemic of COVID-19, for which there is no effective therapy. And any new therapy can be used in medical practice only if its e

Interview with Emma B. Holliday, MD, author of Women’s Representation Among Lead Investigators of Clinical Trials in Oncology

The nucleoside inhibitor has advantages over Gilead's remdesivir but has yet to be tested in humans

Drugmakers want to keep trials going but acknowledge that medical resources are strained

Tests of 10 or more novel vaccines could be underway by mid-May

The antimalaria drug will be tested for treating or preventing the disease in thousands of people worldwide

Despite the hype, support for the use of chloroquine and its relative hydroxychloroquine outside a clinical trial remains mixed

Interview with Stephen MacMahon, DSc, FMedSci, author of Industry-Sponsored Clinical Trials in Emerging Markets: Time to Review the Terms of Engagement

Interview with Aaron S. Kesselheim, MD, JD, MPH, author of Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

Interview with Paul J. Young, PhD, author of When Should Clinicians Act on Non–Statistically Significant Results From Clinical Trials?