• CDOs and Data Science's Evolving Role in Healthcare and Life Science

    Clinical Informatics News | CAMBRIDGE, Mass.—Want to succeed in the healthcare or life-sciences sector as a top-tier, influential executive in the world of big data and analytics?  Top experts convening at the Massachusetts Institute of Technology this month advised that, among other things, the key lies in fostering a collaborative corporate culture and working well with others.

    Jul 25, 2016

  • Chinese scientists to pioneer first human CRISPR trial

    Nature News & Comment |  Gene-editing technique to treat lung cancer is due to be tested in people in August. Sichuan University's West China Hospital in Chengdu plans to inject lung cancer patients with cells modified using the CRISPR-Cas9 gene-editing technique. The clinical trial received ethical approval from the hospital July 6.

    Jul 22, 2016

  • Computationally Predicting Drug Combos

    Clinical Informatics News  The urgency to find treatment for his ailing father inspired an MIT professor to develop a method to successfully predict cancer therapy outcomes, replacing intuition with data, potentially saving millions of dollars, and extending patients’ lives up to six months.

    Jul 21, 2016

  • 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