Wednesday, June 1, 2016
The Senate Committee on Appropriations has approved legislation that provides for the inclusion of “brain cancer” among the disorders eligible for study by the Department of Defense‘s (DoD) Peer Reviewed Cancer Research Program (PRCRP). This provision was included in the fiscal year 2017 Defense Appropriations Act, and mirrors action taken by the House on May 11 to add brain cancer to the PRCRP in its version of the Defense Appropriations Act.
The reputation of the pharmaceutical industry is improving in spite of high-profile negative publicity in the past year, according to the 2016 Global Pharma RepTrak released by Reputation Institute.
Biotrial, a medical research center in Rennes, France, has released a statement expressing shock over Health Minister Marisol Touraine’s statements regarding a recent trial that caused the death of a patient.
In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort to increase the efficiency of the complex process of requesting unapproved drugs outside of clinical trials for “compassionate use.”
A rapid increase in the use of wearable technology and an upsurge in social media for patient recruitment are two of the more prevalent clinical trial technology trends, according to a new survey from the Association of Clinical Research Organizations (ACRO).
Biomedical Research Alliance of NY (BRANY), a national organization providing support services to research institutions and investigators in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials, has acquired the Collaborative Institutional Training Initiative Program (CITI), a provider of online research ethics education to the research community.
Public Citizen has filed a Freedom of Information Act (FOIA) lawsuit against the FDA, asking the agency to post unredacted copies of the curricula vitae (CV) of advisory committee members on its website.
On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.