TeleMed Text: Clinical Operations Groups—Key to RBM Activities

Eighty-nine percent of clinical operations groups within pharmaceutical and medical device companies are involved in risk-based monitoring (RBM) activities, according to a study from Cutting Edge. The study, Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes, found that 73% of surveyed CROs have dedicated risk assessment teams, clinical trial investigators, and clinical operations units that are involved in risk-based monitoring activities.

healthcare-watch-1“The idea behind risk-based monitoring is to develop a practice that helps companies maintain their clinical trial protocols without creating more work for sponsor or CRO teams,” says Sarah Ray, Senior Research Analyst at Cutting Edge Information. A vast majority of healthcare and device companies are using RBM strategies to lower spending, and outsourcing their teams seems to be the most efficient method. Companies find more success in outsourced RBM-dedicated teams mainly because leading their own studies results in over complication of the processes. The study gives details regarding RBM best practices, RBM trends, key steps to help implement RBM and reduce overall costs, and profiles of life sciences companies that participate in RBM.

Therapeutic Talk: New Therapeutic Target for Alzheimer’s

A mutation dysfunction caused during processes cells use to transport molecules within themselves plays more of a role in Alzheimer’s disease (AD) than previously suspected, a new study proves. This new evidence also suggests the mutation may be treated with existing therapeutic enzyme inhibitors. The study’s senior author, Larry Goldstein, PhD, and professor at UC San Diego School of Medicine, explains, “Our results further illuminate the complex processes involved in the degradation and decline of neurons, which is, of course, the essential characteristic and cause of AD.” The specific condition indicated by these studies currently has no treatment.

healthcare-watch-2Mutations that cause abnormality in endocytic trafficking—the process by which cells package large, external molecules into vesicles or membrane-bound sacs for transport into the cell—can be a less studied way in which protein plaques build on cells, eventually leading to their death. Focusing on this previously rarer form of acquiring Alzheimer’s provides more possibilities for targeting treatment at enzymes previously ignored. Further studies at UC San Diego School of Medicine will evaluate possible therapies for the condition caused by genetic mutation.

Trend Setting: Testing for Colon Cancer—at Home

To help eradicate colon cancer, Exact Science created the first non-invasive, at home screening test kit that’s covered by Medicare. Colon cancer is the most preventable, yet least tested type of cancer. Cologuard, an easy-to-use kit sent right to your door with 24/7 technicians on call for support, can change this startling fact. The test uses stool samples to detect colorectal neoplasia-associated DNA markers and for the presence of occult hemoglobin. If these cells have shed from the colon and appear in the test, it may indicate colorectal cancer or advanced adenoma and will warn a patient to get a diagnostic colonoscopy.

healthcare-watch-3The test analyzes both stool DNA and blood biomarkers and is proven to find 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients, which include men and women 50 years of age and older. Detecting colon cancer in its precancerous polyp phase results in drastically more successful treatment. This disruptive technology could help change the playing field in early detection of diseases of the GI tract.

Discoveries/Innovations: Antidepressants for Moms Linked to Speech Issues in Children

Pregnant women who have filled at least two prescriptions for a selective serotonin reuptake inhibitor (SSRI) have a 37% higher risk of having children with a speech and/or language disorder than women who did not use antidepressants. SSRIs include medicines such as Lexapro, Paxil, Prozac, and Zoloft, according to a JAMA Psychiatry study.

Alan Brown, an author on the study, remarks, “To our knowledge, this is the first study to examine the relationship between maternal antidepressant use and speech/language, scholastic, and motor disorders in offspring.”

More than 845,000 pregnant women in Finland were studied between 1996 and 2010 and their children were monitored until age 3. The study does not rule out the possibility that severe maternal depression itself could have these effects on offspring. Researchers and doctors alike agree that the findings are minor enough that mothers with severe depression should not cease their medication. Depression can have very adverse side effects on the mother to be, as well as put large amounts of stress on the unborn baby.

FDA Update

Drug Approvals

The FDA approved the Flublok influenza vaccine made by Protein Sciences Corporation. The new formula protects against four strains of flu virus as opposed to three. The vaccine is available for adults 18 and over in pre-filled syringes.

Accelerated Approval

Eli Lilly and Company received accelerated approval for Lartruvo (olaratumab), a treatment for patients with soft tissue sarcoma (STS). The drug is indicated for patients not able to be treated by radiotherapy or surgery.

Priority Review

The FDA granted priority review to Roche’s Lucentis to consider adding a new indication for the treatment of myopic choroidal neovascularization (mCNV). Data shows that Lucentis provides superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT), the only treatment currently approved by the FDA for the condition.

Orphan Drug Designation

MediciNova was recently granted orphan drug designation for its MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). This is a rare disease for which riluzole is the only currently approved treatment option.

Med Device Approvals

The FDA has approved St. Jude’s Amplatzer PFO Occluder device for reducing recurrent strokes in patients who previously had a stroke caused by a blood clot in the small hole of the heart called the PFO, which then travels to the brain. The device is inserted through a catheter placed in a vein in the leg and advanced to the heart to close the PFO hole. The method is a non-surgical option for preventing future possibilities of stroke for those who have a PFO.


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