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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.

'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. ...

EC, EU and WHO share 'need to know' private drug data

23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.

Italy bans 7 APIs from compounding pharmacies after off-label abuse

20-Aug-2015 - The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.

WuXi finds success in pilot testing of edible microtags

11-Aug-2015 - Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.

Agilent and A*STAR to develop glycan analysis methods more suited to commercial setting

17-Jul-2015 - Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.


Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials

26-Feb-2015 - The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from...

Amended Chinese GCP could aid development of CRO industry

20-Feb-2015 - The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part...

No GVK Bioscience trialled drugs under EMA spotlight are sold in Switzerland says Swissmedic

12-Feb-2015 - None of the drugs the EMA wants suspended over concerns about data manipulation at GVK Biosciences are sold in Switzerland says Swissmedic.

India aims to make new clinical trial rules permanent with draft bill

07-Jan-2015 - India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill  that would amend the country’s landmark law governing pharmaceuticals from 1940.

CDSCO says Indian hospital charged for stem cell treatments given during unapproved trial

15-Dec-2014 - Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.

USFDA issues track and trace draft guidance for third-party logistic firms

11-Dec-2014 - Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.

CROs encouraged by new NIH policy calling for single IRB to speed trials

04-Dec-2014 - CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials...

Medidata: Prepare to embrace digital biomarkers in trials or lose competitiveness

25-Nov-2014 - The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.

China sets new requirements for hospitals running clinical trials

10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

News from CPHI Paris

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.


EMA opens investigation into India’s GVK Bio over ECG falsifications

26-Sep-2014 - At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified...

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