Social networking may someday become a part of clincal trials on medical devices and drugs.
A recent trial found that lithium carbonate didn’t slow the progression of Lou Gehrig’s disease, or amyotrophic lateral sclerosis (ALS), but the study also indicated that the use of a social network to enroll patients and report and collect data could facilitate future studies.
The study was based on data contributed by 596 patients with the neurodegenerative disease and published online in Nature Biotechnology. It represents an early example of how social networking could play a role in clinical trials, which have strict protocols prohibitive of any implementation in web-based media, which typically lack privacy and a any methods for clinical observation.
"This is the first time a social network has been used to evaluate a treatment in a patient population in real time," Jamie Heywood, who co-authored the study, said in prepared remarks.
"While not a replacement for the gold standard double blind clinical trial, our platform can provide supplementary data to support effective decision-making in medicine and discovery," he said.
Heywood is co-founder of Cambridge, Mass.-based "health data-sharing website" PatientsLikeMe, which builds a social networking platform that uses health information provided by patients to help researchers study diseases.
PatientsLikeMe conducted the study by taking the 2008 research and matching it to patients who reported taking lithium with other ALS patients that had similar disease courses, the company said. PatientsLikeMe said its proprietary algorithm enabled the it to "reduce biases associated with evaluating the effects of treatments in open label, real world situations and improve the statistical power of the study making each patients contribution more meaningful," in a release touting the study’s findings.
Here’s a roundup of recent clinical trial and scientific study news:
- Study: Posterior tibial nerve stimulation treats overactive bladder syndrome
Researchers from the Dept. of Obstetrics and Gynecology, Division of Urogynecology, Saint Louis University, sought to determine the efficacy of posterior tibial nerve stimulation in patients who had failed anticholinergic medications. A secondary outcome was to determine the time to response for different parameters of overactive bladder. A total of 141 patients were analyzed. Of these patients, 67.4 percent were satisfied with treatment results. The results showed that posterior tibial nerve stimulation is an effective treatment of overactive bladder in patients who have failed anticholinergic therapy. The study was published in the March-April 2011 issue Female Pelvic Medicine & Reconstructive Surgery.
- First patient enrolled in Gore Ascites study
W. L. Gore & Associates reported the first patient enrolled in the Gore Early TIPS for Ascites Study. The patient was treated at Indiana University Hospital in Indianapolis, Ind. The objective of this prospective, randomized, multi-center clinical study is to evaluate whether the TIPS procedure with the GORE VIATORR TIPS Endoprosthesis improves transplant-free survival when compared to large volume paracentesis (LVP) in patients with cirrhosis of the liver and difficult to treat ascites. The study is expected to be the largest and most rigorous multi-disciplinary collaboration with hepatologists and interventional radiologists looking at early TIPS therapy. A total of 150 subjects will be enrolled at approximately 20 sites.
- NeuroSigma announces new data on "USB port to the brain"
NeuroSigma Inc., a Los Angeles-based medical device company, today announced research progress on three therapies employing trigeminal nerve stimulation (TNS), originally developed at UCLA and exclusively licensed to NeuroSigma. NeuroSigma is developing two embodiments of TNS: eTNS (TNS with external electrodes and an external pulse generator) and sTNS (subcutaneous electrodes and implantable pulse generator). The eTNS system utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin above the forehead.
- Two-year DES matchup indicates Abbott’s Xience V beats BosSci’s Taxus
The two-year results from the Comparison of the Everolimus-Eluting Xience-V Stent with the Paclitaxel-Eluting Taxus Liberté Stent (COMPARE) and SPIRIT IV trials, published online April 20, 2011 in the Journal of the American College of Cardiology, confirm that the everolimus-eluting Xience V stent (Abbott Laboratories (NYSE:ABT)) consistently outperforms two different versions of the paclitaxel-eluting Taxus stent (Boston Scientific Corp. (NYSE:BSX)), reports HeartWire.
- BNP predicts post-transplant heart function
Higher levels of brain-type natriuretic peptide (BNP) in brain-dead heart donors correlated with reduced cardiac output and cardiac index in the hearts’ recipients in a small study reported at the International Society for Heart & Lung Transplantation (ISHLT) 2011 Scientific Sessions, according to HeartWire. Researchers are envisioning donor screening.
- Study: LVADs are successful bridge from failed heart transplant to retransplant
Patients with a failing cardiac graft one year posttransplant can be safely bridged to retransplantation with left ventricular assist devices (LVADs), according to an analysis of the United Network for Organ Sharing database, reports HeartWire.