• NIH Policy Calls for Multi-Site Research to Use a Single IRB

    Clinical Informatics News | The National Institutes of Health (NIH) has issued a new policy stating that all NIH-sponsored multi-site research protocols within U.S. jurisdiction must use a single Institutional Review Board  across all sites.

    Jul 18, 2016

  • JAX, AMA, Scripps Launch Genomic Education for Physicians

    Clinical Informatics News | The American Medical Association (AMA), in partnership with Scripps Translational Science Institute (Scripps) and The Jackson Laboratory (JAX), have announced a new online program aimed at educating physicians and other health care professionals on the benefits and limitations of genetic testing and when it is appropriate to incorporate it into their practices.

    Jul 14, 2016

  • Juno Therapeutics Re-Starts Cancer Trial After Deaths Put Study on Hold

    Forbes |  Juno Therapeutics has been given the green light to re-start a cancer clinical trial less than a week after regulators put it on hold because of three patient deaths. The Seattle biotech company, a leader in the emerging field of engineered T-cell immunotherapy for cancer, said today the FDA has allowed it to start enrolling patients once again.

    Jul 13, 2016

  • Researchers Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria

    RAPS |  A team of researchers say that no currently available patient-reported outcomes for heart failure meet the FDA's criteria for supporting product approval.

    Jul 13, 2016

  • Cannabis Trials, New Products for Payment, ICON Acquisition

    Clinical Informatics News | News and product updates from around the clinical trials industry include a cannabis trial, new options for trial payments, Medidata's Clinical Cloud in Asia, and more.

    Jul 12, 2016

  • A Powerful Tool for Rare Disease Research

    Clinical Informatics News | Contributed Commentary | When developing a new treatment for a rare disease, the first thing developers should do is build a patient registry for their target patient population. Rare disease patient registries are online platforms where patients and caregivers record information about their diagnosis, condition, and treatment experience. These platforms give developers a mechanism to gather valuable insights that will shape their research and help them demonstrate effectiveness to regulators and payers as part of the approval process.

    Jul 8, 2016

  • Obama Seeks To Make Mark On Genetic Medicine

    Forbes |  After a few weeks of hype around the Obama administration's efforts to speed cancer research, officials tonight announced plans to kickstart efforts around the president's Precision Medicine Initiative.

    Jul 7, 2016

  • In clinical trials for-profit review boards staged a revolution

    STAT |  The rise of commercial institutional review boards has led to questions over whether they can adequately protect the safety of study participants.

    Jul 6, 2016

  • News and Products from DIA 2016

    Clinical Informatics News Roundup | News and announcements are coming fast out of the Drug Industry Association meeting in Philadelphia. Highlights here come from DrugDev, Veeva, inVentiv, Bracket, and MasterControl. The roundup will be updated throughout the week.

    Jun 28, 2016

  • It’s Site Selection, Not a Toss of the Dice

    Clinical Informatics News | Guest Commentary | Conducting clinical trials is a high stakes game, but disturbingly, the risk of selecting non-performing or underperforming investigative sites is greater than losing at the gambling table. When shooting craps, for example, odds are 17% that the player will role a 7 to start the action, and the odds of actually winning may be even lower. But, the odds of selecting sites that perform well in clinical trials are worse, far worse.

    Jun 27, 2016

  • CIOs tell ONC Its time to let the EHR market innovate to drive interoperability

    Healthcare IT News |  Several experts contend that the Office of the National Coordinator for Health IT is attacking the wrong problems and the last thing anyone needs is more prescriptive regulation about EHR functionality, usability and quality measurement.

    Jun 27, 2016

  • Reality check from Eric Lander Cancer cure isnt around the corner

    STAT |  Eric Lander says it will take several decades to find a cure for cancer. Speaking at the Aspen Ideas Festival, Lander said patient data sharing would make the difference.

    Jun 27, 2016

  • Clinical informaticist says the best is yet to come for FHIR

    Healthcare IT News |  InterSystems' Russell Leftwich, MD, says 'there's still a lot of data yet to be incorporated' with the HL7 standard.

    Jun 24, 2016

  • NEA Leads $44M Bet That Protecting Synapses Will Help Fight Alzheimers

    Forbes |  Alzheimer's might be the most frustrating graveyard in pharmaceutical R&D. Billions are being wagered on the idea that reducing amyloid plaque buildups will help slow or stop the memory loss and cognitive decline in old age. Nothing really works. Now a startup in South San Francisco has raised $44 million to take a different tack.

    Jun 23, 2016