Clinical Research News Roundup — September 26, 2014

EMA Proposes Plan To Cut Duplication Of Trials In Children

The European Medicines Agency has proposed a single development plan for vaccines that fight against diphtheria, tetanus, and whooping cough in an effort to cut down on children’s exposure to clinical testing. While the current testing and vaccination process has been successful across the EU, the agency is concerned by the fact that children are routinely patients in a number of similar clinical trials while a new vaccine is in development. In collaboration with the European Center for Disease Prevention and Control, the EMA has established a single schedule for pediatric clinical trials that consist of two priming doses at ages two months and four months, followed by a booster dose at one year of age. More studies may be necessary however, if the vaccines are given in combination with another vaccine.

Should Ovarian Cancer Trials Adopt Different Endpoints?

An article by the Society of Gynecologic Oncology argues the need for alternative clinical trial endpoints to overall survival in ovarian cancer studies, such as response rate, progression-free survival, and patient reported outcomes, among others.  The Society argues that overall survival is not an appropriate enough endpoint for ovarian cancer trials because of these trials’ multiple-treatment strategies.    

Sponsors Increase Remote Access To TMF

Clinical Trial sponsors are becoming more willing to allow regulators remote access to their electronic trial master file, the Veeva 2014 Paperless TMF Survey found. According to Veeva’s report, more than 32 percent of TMF owners claim that they plan to allow remote access to their eTMF in 2015. Currently, only 16 percent have granted auditors this opportunity. Technology still remains a key barrier for some in this process. In particular, 12 percent claim that they would open up their eTMF “as soon as they have the technology to support it.” The survey also found that respondents believe integration with an electronic data capture (EDC) and clinical trial management system (CTMS) is necessary to achieve a paperless TMF.

FDA’s Social Media Guidance Gets Some Industry Kickback

The comment period for the FDA’s most recent draft guidance on the use of social media in pharma closed last week, however according to The Hill, members of the industry still believe the guidance has a long way to go. The Hill says that pharma companies are primarily concerned the FDA would hold pharma companies responsible for any incorrect information that third parties would post online about the companies’ products. If this is the case, pharma believes that this would alienate the industry from consumers, as the current draft guidance would keep companies from interacting on social networks and would leave consumers in the dark about specific medical products. 

Expert Says Expect “Fundamentally Different” Drug Discovery, Development

A MedicalXPress article discusses the changing infrastructure of the pharmaceutical industry and what this means for research and drug discovery. According to Yale’s former managing director of Yale Center for Molecular Discovery, Michael Kinch, pharma’s outsourcing discovery of new drug targets led to the rise of biotechs. However, as many biotechs are now being acquired by big pharma, Kinch expresses concern over where drug discovery and early development will occur, especially as many pharma companies keeping their eyes on the market invest drug development funds on late stage trials and, therefore, do not possess ample R&D capabilities.

Independent Clinical Trial Result Re-Analyses Percentages Raise Concerns

A Wall Street Journal blog discusses the results of a recent study published in the Journal of the American Medical Association that revealed there has been very little independent analyses of randomized controlled trials published in the industry. In fact, only 37 have been republished from 1966 to March 2014. According to the authors of the study, this small percentage is rather concerning because “reproducibility is an important step to ensure that the findings of original trials are not distorted, biased, or incomplete.” One of the co-authors also expressed concern over the fact that many of the republished analyses boasted different conclusions about how patients should be treated than had been found in the original trial. “One would like to have trusted that the results and conclusions of randomized trials are reproducible and not subjective or dependent on who analyzes their data and how the data are analyzed,” co-author John Ioannidis said.