Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.
A consumer rights watchdog is calling on regulators to suspend research at a Minnesota-based medical facility in response to concerns surrounding informed consent for a study involving Ketamine.
ACRP is partnering with a Singapore-based institute to ensure the workforce is appropriately trained ahead of anticipated growth in clinical trials throughout Asia.
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
Clinical trial participants often misunderstand the differences between research and clinical care – a ‘longstanding problem’ that an enhanced informed consent process could diminish, says report.
CTTI has released new evidence-based recommendations to enable sponsors and investigators to better plan for and make decisions about pregnancy testing in clinical trials.
WIRB-Copernicus Group (WCG) has acquired eConsent technology to help clinical trial volunteers – and their families – make more informed decisions, says CEO.
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
The study will evaluate how critical biomarkers and cell-therapy cancer vaccines are impacted by temperature and transport packaging at deep frozen temperatures.
The US government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).
A drugmaker trialling an autoimmune disease treatment in the UK has been cleared to use electronic informed consent by the National Health Service (NHS).
The 21st Century Cures Act may actually offer the FDA too much discretion to approve drugs without conventional clinical trials, and in some cases “on the basis of less rigorous data,” two medicine professors from Harvard write in an editorial in the...
Despite a growing interest in adaptive clinical trial (ACT) designs, few designs have been used relative to the overall number of trials conducted, and more ethical concerns need to be considered, according to a new study published Sunday from University...
Dublin-based CRO Icon is sponsoring a series of research projects at Carnegie Mellon University as part of a long-term partnership to find new ways to improve the comprehension and retention of informed consent documents by clinical trial participants.
The draft guidance comes in the form of a Q&A and offers clinical investigators, IRBs and others a look into how electronic informed consent (eIC) should be done properly.
More commentary on the US FDA’s informed consent draft guidance is trickling out, this time with ACRO (Association of Clinical Research Organizations) and the Dana Farber Cancer Institute offering their take on what should be included in the final guidance.
The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.
For the first time since 1998, the US FDA is offering draft guidance on what it expects from IRBs (institutional review boards), clinical investigators and sponsors regarding informed consent.
The Center for Responsible Science has asked the US FDA to adopt informed consent rules which ensure that trial participants know the experimental drugs they receive may be unsafe or ineffective.
As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
Draft revisions to the Declaration of Helsinki (DoH) clarify how placebos should be used and add a general principle for adequate compensation to injured trial participants according to the WMA.
The head of Pfizer's virtual clinical trial has defended the project after its initial failure to recruit patients raised questions about its viability.
Easily translatable and adaptable simplified clinical research ethic training guidelines have been created to support field workers in low-resource settings.
The increasingly global clinical trial sector demands more effective ethical and regulatory scrutiny according to a study published in the latest edition of the New England Journal of Medicine (NEJM).
Pfizer is vowing to fight on as Nigerian court battles against its
subsidiary in the country wage on over its alleged involvement in
child deaths through experimentation over a decade ago.
Pfizer has had its first day in a Nigerian court in a legal dispute
over its alleged involvement in the death of Nigerian children
during a clinical trial 11 years ago.
GlaxoSmithKline (GSK) has denied allegations that some of its
vaccines have been tested illegally and against good clinical
practice (GCP) in children in Russia.
After recent allegations in the media that poor and illiterate
patients in India are being used, often unknowingly, as human
guinea pigs to test new drugs for the pharma giants of the West,
Outsourcing-Pharma takes a look at how cutting...
