Biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) revealed on Tuesday that it has signed a clinical trial
transparency agreement with Duke University's Duke Clinical Research Institute (DCRI), an academic clinical research organisation that conducts groundbreaking multinational clinical trials
Registry (CTR) provides an internationally-concurred set of details about the design, conduct and implementation of the clinical trials
* In the case of a multisite clinical trial
, if the informed consent documents have been approved for one or more sites, but not for all sites, before 7 March 2012, the trial will be considered to have initiated before 7 March 2012; the new requirement accordingly will not apply, and the informed consent documents for the remaining sites do not have to include the required statement.
An introductory chapter explains the basics of a clinical trial
using examples as well as touches upon the ethical and regulatory considerations associated with the conduct of a clinical trial
"We recently surveyed 145 diabetes patients who had previously participated in a clinical trial
," explains Ryan Luce, co-founder of Corengi.
Many demographic factors coupled with systematic factors related to rural life in general, such as lower literacy rates, and low numbers of available cancer clinical trial
studies create a challenge for West Virginia cancer providers to bring cancer clinical trials
to their patients.
registration : looking back and moving ahead.
The IND allows the commencement of a pivotal phase III secondary progressive MS clinical trial
in the US and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing clinical studies for MBP8298.
The network will be able to provide information on participants in clinical trials
to 200 affiliated medical institutions on a real-time basis.
This program announcement is a reissuance of PAR-04-065, and specifically encourages the submission of applications for pilot and feasibility clinical and translational research studies, including clinical trials
, and epidemiologic studies, related to kidney or urologic disease research that address important clinical and translational questions and are potentially of high impact.
Instead, a new clinical trial
would have to start over and test the generic to treat the disease in patients in order to be approved for that use, as if the first trial had not been done--an unnecessary trial because it would require patients to take risks to reprove what had already been well established.
The CRO physician may co-author a peer-reviewed journal article after overseeing a particularly significant clinical trial
or provide comment on behalf of the CRO to a government agency on a proposed regulation or policy affecting the drug development and approval process.