Schering-Plough adopts global clinical trials model
standardise its clinical trial operations throughout the world -
aimed at improving trial consistencies, efficiencies and saving
The company will soon implement a new management system that will oversee all of its clinical trials worldwide through a centralised process conducted from its headquarters at the Schering Plough Research Group (SPRG), based in Kenilworth, New Jersey.
Under the new Global Clinical Harmonization (GCH) program, all clinical trials will be held to a consistent set of standards, policies and practices, regardless of trial type, phase or geography, said the firm.
This new model will replace the current previously decentralised approach, where all the company's preclinical to Phase III trials are co-ordinated from SPRG and the Phase IIIB and IV (post-marketing) studies are handled by the company's Global Medical Affairs department or by the local branch of the company in the specific country that the trial was being carried out.
The climate in the industry since the dramatic high profile withdrawal of Vioxx in 2004 has created a new sensitivity within drug companies, as the US Food and Drug Administration (FDA) has tightened its regulatory controls to make them more accountable for transparency of its clinical trial data.
All drug study data gathered throughout the world by pharma companies, be it positive or negative, can now be subpoenaed by the FDA and because so many money-spinning drugs are now sold under the same brand globally, results of a negative localised trial conducted in Germany, for example, could have resonating implications for the brand worldwide and this threat is becoming too much for drug companies to risk.
As a result, big drug companies are now more wary of the nature of the trials they conduct, who in the company can initiate them, and what organisations they trust to conduct them and to regain control, big pharma headquarters have been pulling back on the budget and authority that its global branches have to conduct localised Phase IIIB and IV research outside the global jurisdiction.
"When fully implemented, the new model we are adopting is designed to result in a global, standardised approach to how we conduct clinical trials and should help ensure better planning and prioritisation and greater consistency in trial execution," said Brent Saunders, senior vice president, Global Compliance and Business Practices.
"The standardisation of our clinical trial practices and processes and the elimination of redundancies, should also result in improved cost efficiencies," company spokesperson Steve Galpin told Outsourcing-Pharma.com.
Despite a recent rise in sales thanks to its rheumatoid arthritis drug Remicade and its cholesterol drugs Vytorin and Zetia, Schering-Plough is in the midst of trying to cut costs as it tries to recover from losses in big revenue losses since its blockbuster, the decongestant Claratin, lost patent protection three years ago.
Just last month Schering-Plough announced the loss of 1,100 positions in manufacturing sites in Puerto Rico and New Jersey in a bid to save $100m (€78.1m) a year.
Galpin said that he is unsure yet as to when the company will implement the new model as "it is a long-term commitment and we are still determining the finer details of how it will work."
"However, we do expect there to be no change in headcount."