eclinical news in brief
Medidata, UBC, Tessella and Datatrak.
Three eclinical industry pioneers are this week hosting the last in a six-part series of free webinars focusing on adaptive clinical trials. To be held on Wednesday, the final installment will focus on regulatory issues in adaptive trials and according to the organizers, will "highlight existing and new guidance from the regulatory bodies and identify key implications for sponsors". The three US firms jointly running the sessions are United BioSource Corporation (UBC), Medidata Solutions and Tessella. Willing participants can register at the companies' websites. They began running the series in July 2007. Adaptive trials have emerged as a hot topic within the clinical arena, as they are becoming recognised as a way of accelerating drug development without "breaking the rules." Through the use of adaptive study designs, clinical trial sponsors effectively have the flexibility to examine early results of a trial half way through and modify its design in order to improve the chances of a positive result, or cancel the study if it appears ineffective. However, they are still somewhat of a regulatory grey area and their use has been limited so far. Despite this, the uptake of such studies is growing at a "rapid pace," the panelists of a Drug Information Association (DIA) Media Roundtable told Outsourcing-Pharma.com last year. "Three hot factors have recently converged to transform the concept of adaptive trials from the realm of theoretically possible to hot," they said. Specifically, the forces driving the uptake of these trials are creative statisticians; willing managers and regulators; and enabling technology, said the panel, who consisted of Alberto Grignolo, DIA annual meeting programme chair; Cynthia Kirk, president, DIA board of directors; Ronald Fitzmartin, president-elect, DIA board of directors; and William Brassington, acting executive director, DIA USA . Meanwhile, another eclinical player, Datatrak, has recently announced the availability on its website of a videocast that highlighting the "value proposition" of for companies involved in running clinical trials who are considering switching to an electronic data capture (EDC) system or re-evaluating their current electronic solution. "Reduced costs, speed to market and enhanced patient safety are the proven benefits of conducting clinical trials electronically", said the firm.
