Philip Ward

An investigation published by the BMJ this week has raised new concerns about the validity of a trial that was used to gain approval for Xarelto from the U.S. and European regulators.

New approach focuses on assessing the effectiveness of four key areas related to risk-minimization and pharmacovigilance activities in Europe.

In addition to the patient education database, guidelines for the interaction of patient organizations with ethics, health technology assessment, regulatory bodies and industry are being developed with the goal of being released later in the year.

Private laboratory Biotrial was testing a pain and mood disorder medication for Portuguese pharma company Bial on humans for the first time, in a Phase I trial.

The discussions will center on ways clinical research can harness gene therapy and new and emerging diagnostic tools.

The BMJ published a detailed report this week about how pharmaceutical sales representatives are screening people in India in return for prescriptions for their products. It also addresses the growing popularity of free “health camps” for poor people in India.

Better access to patient information would enable researchers to answer new questions with existing data, validate findings, and combine the power from individual studies.

Addressing the challenges unique to purely industry-sponsored trials is explored.

Rasi was forced to step down in November 2014 by the EU Civil Service Tribunal after a panel of experts found the European Commission (EC) had used improper procedures when it had selected him back in 2011.

The U.K. National Health Service (NHS) has granted approval for what is thought to be the first use of electronic informed consent in England.

How can you navigate the regulatory triangle safely?

The use of small animal models in basic and preclinical research is now an integral part of developing and testing new drugs.

Double-blind randomized controlled trials of new drugs may fail to measure how a medication’s performance can vary based on patients' lifestyle choices, especially if patients change their habits because they are anticipating treatment, according to a new study published in Plos One.

In the U.S. alone, around $28 billion a year is spent on preclinical research that is not reproducible, and low reproducibility rates contribute to both delays and costs of therapeutic drug development.

The congress will be held at the Congress Center Hamburg (CCH) in Germany on 6 to 8 April 2016. For the first time, it will feature one or more sessions on medical writing.

The manipulation of data from studies conducted in India have led the European Medicines Agency (EMA) to confirm suspensions of a number of medicines.

It is critical that partners in clinical research develop systems to maximize the potential of big data while protecting the confidentiality of patient information, to further biomedical research, continued the statement, according to a statement from the European Federation of Pharmaceutical Industries and Associations.

Altman has been instrumental in the development of “truly robust guidelines for the reporting of clinical trials and wider clinical research studies”.

The European Medicines Agency (EMA) has updated its rules on declarations of interests for scientific committee members and experts.

The first malaria vaccine candidate (RTS,S/AS01) to reach Phase 3 trials is partially effective against clinical disease in young African children up to four years after vaccination, according to final trial data published in The Lancet, which will now be evaluated by the European Medicines Agency (EMA).

Clinipace Worldwide has announced the takeover of Accovion, a CRO with a head office in Frankfurt (Eschborn), Germany.

Researchers at the University of Manchester and Central Manchester University Hospitals NHS Foundation Trust (CMFT) have published new data about public knowledge of, and interest in, the process of medicines R&D.

The use and number of cognitive-enhancing drugs is likely to grow substantially in the coming years, and researchers must prioritize the potential advantages and dangers of their use in healthy subjects, according to U.K. neuroscientists writing in The Lancet Psychiatry journal.

In a crucial part of the European Patients’ Academy (EUPATI) strategy, 47 patients and patient representatives from across Europe are meeting this week in Barcelona, Spain, to continue their 13-month online training course to become expert patients in the medicines development process.

Denis Lacombe, M.D., has been appointed Director General of the Brussels-based European Organisation for Research and Treatment of Cancer (EORTC).

The use and number of cognitive-enhancing drugs is likely to grow substantially in the coming years, and researchers must prioritize the potential advantages and dangers of their use in healthy subjects, according to U.K. neuroscientists writing in The Lancet Psychiatry journal.

Initiative designed to boost understanding of medical device development in Europe.