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Author Archives: Philip Ward
New Patient Group Gets Muted Response—So Far
It’s probably fair to say that the European Patients’ Academy on Therapeutic Innovation (EUPATI) has made a rather slow start since its launch on February 1. There doesn’t seem to have been a huge blaze of publicity or a massive wave enthusiasm for the new group, which has so far amassed a mere 13 followers [...]
BMJ Wages War on Missing Trial Data
The editors of the British Medical Journal have certainly started the New Year in a determined and resolute mood. They’ve published a special issue this week about missing data in clinical research, arguing that this problem distorts the scientific record to the extent that clinical decisions cannot be based on the best evidence.
This is not [...]
Posted in Uncategorized Tagged Beth Hart, BMJ, British Medial Journal, data, Elizabeth Loder, Joseph S. Ross, Philip Ward, Richard Lehman Leave a comment
Dutch Scandal Puts New Emphasis on Fraud Prevention
Research misconduct has resurfaced in spectacular fashion after a scandal involving a professor at a top European university hospital has rocked the global cardiology community.
The Erasmus Medical Center (MC) in Rotterdam, the Netherlands, dismissed Professor Don Poldermans on November 16 because of violation of academic integrity. Research carried out under his leadership was not always [...]
It’s Time to get Savvy About Biomarkers
After the brief summer break, the conference season is now back in full swing, and one meeting that caught my eye this week was a three-day event that focused on biomarkers in clinical trials, held in London.
In the past, biomarkers were largely used to determine whether a patient responded to a treatment, but they are [...]
Posted in Regulatory Tagged 5th Annual Biomarkers Summit, BioCARE, biomarkers, Biomarkers in Cancer Medicine, Carl-Johan Ivarsson, EU, London, oncology, Philip Ward, Qlucore, R&D Leave a comment
Amid the Riots Comes Good News for London
It’s been a dreadful few days for London and the UK as a whole. Scenes of rioting, looting, and indiscriminate violence have been shown across the world. The country’s not in turmoil and anarchy, as some sensationalist tabloid newspapers have suggested, but the troubles have come as a nasty shock to everybody.
Amid all the negative [...]
Posted in Regulatory Tagged EMA, European Medicines Agency, London, Philip Ward, riots, UK Leave a comment
Predicting the Future of CTMS
You have to admire the boldness of market report writers. They often make incredibly confident long-term predictions, and clearly they must have a crystal ball to enable them to see so far into the future. No wonder their output tends to cost so much.
Take, for example, the press release that I received today from companiesandmarkets.com. [...]
Posted in IT Tagged clinical trial management systems, companiesandmarkets, CTMS, future, market, SaaS-based solution 1 Comment
Italy Bounces Back From Financial Scandal
Yesterday’s announcement that the European Medicines Agency’s management board has nominated Guido Rasi as the new executive director suggests that key decision-makers are now willing to completely trust Italian regulators.
The country’s pharma industry was rocked by scandal during the 1990s, when Duilio Poggiolini, the ex-director of the Ministry of Health’s pharmaceutical service, was found guilty of [...]
Posted in Regulatory Tagged Duilio Poggiolini, EMA, European Medicines Agency, financial, Guido Rasi, Italy, Ministry of Health, Philip Ward, scandal Leave a comment
Yes, Registries Really Are Sexy
Mention the word “registry” to most clinical trial organizers, and you’re unlikely to get an animated response. It’s a bit like pensions: we all know we should really be interested in them, but it’s not exactly a topic that sets the pulse racing for the bulk of us.
Posted in CRO/Sponsor, IT, Regulatory Tagged draft guidance, EMA, European Medicines Agency, online register, Philip Ward, registries Leave a comment
Europe’s Top Regulator Shows His Teeth