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Patient safety

Patient safety

Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.

EMA revises guideline on first-in-human clinical trials

27-Jul-2017 - The adapted guideline stresses a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials.


Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections

25-Jul-2017 - Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).

DIA 2017

When, where, and how? Experts examine the current state of Brexit

13-Jul-2017 - The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.

ACRO: Right to Try Act compromises clinical trial process

25-May-2017 - Enhanced clinical trial design legislation proposes an alternative to the Right to Try Act – both of which address the FDA's current compassionate use program.

Clinical trial study design: 'one size does not fit all'

18-Apr-2017 - The rate of false positives in clinical trials should be set higher for certain hard-to-treat cancers, suggest researchers.

Celerion adds biometric fingerprint tech across units

15-Mar-2017 - Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.

Will deregulation trump clinical trial patient safety?

01-Mar-2017 - The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.

Final Rule 'modernizes' protections for clinical trial participants

19-Jan-2017 - The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.

Packaging design: how to ensure successful patient outcomes

19-Dec-2016 - As holidays shoppers wrap up their presents with ribbons and bows, reviews how contract pharmaceutical packaging companies help ensure successful patient outcomes with iterative design.

Two more patients die in trial of Juno's JCAR015

23-Nov-2016 - Two more patients have died during a trial of Juno Therapeutics’ candidate white blood cell cancer therapy, JCAR015.

Product recall after mechanism failure complaints

Teleflex recalls faulty nasal delivery devices used to administer opioid overdose meds

10-Nov-2016 - Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis"....

Researchers question traditional efficacy trial model

06-Sep-2016 - According to a recent study, traditional efficacy trials have limited applicability in everyday clinical practice – an issue which researchers say needs to be amended.

Adaptive designs: patient value and commercial benefits

17-Aug-2016 - As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.

EMA proposing changes to FIH clinical trials, accepting comments

26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.

Juno submits 'Complete Response' to FDA following 3 deaths in ph II trial

12-Jul-2016 - The FDA has placed on clinical hold on Juno’s Ph II clinical trial of JCAR015 following the death of two patients last week and will “continue to work” to ensure...

DIA 2016

Fatality in clinical trials: DIA panel discusses FIH trials

29-Jun-2016 - After the Bial trial tragedy earlier this year, panelists gathered at DIA to discuss what went wrong and how to move forward as an industry. 

'Industry-first' electronic consent platform reduces risk, says CRF Health

25-May-2016 - CRF Health has launched TrialConsent, an electronic solution promoting better comprehension, compliance, and retention rates in clinical trials.

BioClinica partnership to support 'continuum of pharmacovigilance services'

20-Apr-2016 - BioClinica and ArisGlobal have partnered to offer customers a comprehensive pharmacovigilance service as "one size fits all" model evolves.

CTI Biopharma confirms a CRO is involved in Ph III trial halted after deaths

15-Feb-2016 - CTI Biopharma has confirmed the Phase III trial halted after patient deaths last week was being conducted by a CRO and in-house researchers.

US FDA halts CTI BioPharma's Ph III cancer drug trial after patient deaths

11-Feb-2016 - The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”

Biotrial run PhI study halted after patient declared brain dead

15-Jan-2016 - A clinical trial being run by Biotrial has been suspended after six serious adverse events.

Parexel: 2016 prescribing decisions to be driven by clinical and real-world data

07-Jan-2016 - In 2016 clinical trial and real-world data will become increasingly important in the decision to prescribe medicine, Parexel President and COO Mark Goldberg told

Dispatches from PCT

Patient-centric trials to give CROs competitive edge, say sponsors

19-Nov-2015 - A more patient-focused approach will expedite clinical trials and responsive CROs will have the competitive advantage, say AstraZeneca, EMD and Bayer.

News focus

Placebo response may be making pain trials tougher

02-Nov-2015 - It has been getting harder and harder for trial sponsors to show that drugs intended to treat neuropathic pain are effective - and the reason is surprising.

Pressure group floats idea of government-backed clinical trial awareness campaign

29-Oct-2015 - The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies. ...

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