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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.

Acurian’s opt-in database hits 70m potential subjects

23-Jan-2012 - Acurian says rapid expansion of its opt-in trial subject database is testament to the efficacy of direct-to-patient communication.

Journals aim at recruitment & data in trial transparency push

04-Jan-2012 - Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.

Simplifying eligibility criteria can cut data fabrication risk

06-Dec-2011 - Simplifying clinical trial eligibility criteria and reducing the number of recorded variables can cut risk of data fraud, statisticians said.

Indian trial compensation guidelines open to comment

28-Nov-2011 - India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.

EMA recalling oncology drugs manufactured by Ben Venue

23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.

Lilly boosts minority participation in trial with new systematic approach

22-Sep-2011 - US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.

Clinpharm Consulting rejigs offering to tackle common PK-PD challenges

15-Sep-2011 - Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize return on R&D investment.

DaVita opens biorepository to support drug discovery

15-Sep-2011 - DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.

EMA aims to spark debate on quality in clinical trials

22-Aug-2011 - The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.

Apps turn iPads & iPods into consent & compliance tools

08-Aug-2011 - Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.

EC drafts GDP guidance to tackle supply chain threats

18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.

Protocols and planning key to avoiding warning letters; FDA

05-Jul-2011 - Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.

Ethical aspect of trials should be part of marketing apps

19-May-2011 - Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.

update

GVK to work with Gates Foundation-funded neglected disease group

16-May-2011 - Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.

India standardising SAE reports

16-May-2011 - Indian regulators plan to standardise clinical trial serious adverse event (SAE) reporting to ensure complete data is submitted.

Clinical trial sites need a proactive compliance strategy

19-Apr-2011 - Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.

FDA to amend trial investigator disqualification regulations

18-Apr-2011 - The FDA is planning to change clinical investigator disqualification regulations following GAO recommendations.

CIT launches LeadScreen and promises preclinical data in just two weeks

12-Apr-2011 - Non-clinical CRO CIT has rolled out a new suite of drug candidate toxicity and safety assays that, it claims, can provide detailed data in just 14 days.