Clinical Trials Archives - ResearchAdministrationDigest.com - Reading the industry so you don't have to

Dubious Value in Describing all Financial Interests as Dubious

Posted on October 9, 2014 by Jeffrey Waldin |

An article in our capital region newspaper noted information on area doctors and researchers who have received payments associated with pharmaceutical companies and device manufacturers, which is now available publicly, similar to other potential conflict of interest reporting. The article…

Being Human and Considering the Role of Human Trials

Posted on September 8, 2014 by Jeffrey Waldin |

The use of an experimental drug to treat a handful of health care and ministry workers infected with the Ebola virus may have attracted more press attention than the outbreak itself. One interesting aspect of this coverage is the platform…

NIH Clinical Center Directors Annual Report

Posted on April 10, 2014 by Matthew Tanner |

Recently, the NIH Clinical Center Directors Annual Report was released by the National Institutes of Health. The NIH Clinical Center is the “world’s largest hospital completely dedicated to clinical research”. In addition to detailing this year’s achievements, this year marks…

Educational Resources for Patients, Advocacy Groups, Research Investigators and Drug Developers regarding Rare Diseases

Posted on March 17, 2014 by Matthew Tanner |

The US Food and Drug Administration (FDA) has recently published a list of “Educational Resources for Patients, Advocacy Groups, Research Investigators and Drug Developers”. These resources are available from the FDA’s “Developing Products for Rare Diseases & Conditions” page, in…

29% of Large Clinical Trials results unpublished after 5 years

Posted on October 31, 2013 by Matthew Tanner |

In the current issue of the British Medical Journal (BMJ), there is an article entitled, “Non-publication of large randomized clinical trials: cross sectional analysis” (BMJ2013;347:f6104). The authors examined clinical trials on clinicaltrials.gov to determine if data from these trials is available to the…

Information Breach – Beware the Photocopier Hard Drive

Posted on August 21, 2013 by Jeffrey Waldin |

One health plan provider learned an expensive lesson. Affinity Health Plan, Inc. returned multiple photocopiers to leasing agents without erasing the data contained on the copier hard drives. As a result, the private health information of up to 344,579 individuals…

Compliance Deadline for HIPAA/HITECH Changes

Posted on July 26, 2013 by Jeffrey Waldin |

Institutions that collect PHI information for research have less than 2 months to make sure that their systems and procedures are in compliance with the Final Rule issued on January 25, 2013. The deadline established for full compliance is September…

Proposal to reduce IBC review of previously reviewed clinical trials

Posted on May 13, 2013 by Matthew Tanner |

Read the Federal Register posting here. From the NIH: The NIH Office of Biotechnology Activities (NIH OBA) proposes to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline review of certain human…

New Zealand Clinical Trials Website Now Available

Posted on April 23, 2013 by Matthew Tanner |

The New Zealand Ministry of Health has launched a new website “Clinical Trials“, to inform the public about ongoing and completed clinical trials. Users can search for keywords that are included in the titles of the clinical trials, and will…

UK pharma scientist jailed over trial fraud

Posted on April 19, 2013 by Matthew Tanner |

From PharmaTimes Online (link): A UK-based pharma scientist has been sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform human trials. Steven Eaton was found guilty at Edinburgh Sheriff’s Court in March…