Clinical Research

After performing thousands of unsuccessful experiments in his attempt to perfect the light bulb, Thomas Edison famously remarked: "I have not failed, not once. I've discovered ten thousand ways that don't work."

Australian leaders of an ongoing pancreatic cancer clinical trial known as the Individualised Molecular Pancreatic Cancer Therapy or 'IMPaCT' trial, can say exactly the same thing as Edison. In conventional terms, the trial has been a failure, because it has been unable to recruit eligible patients to-date, but that may lead to a new paradigm of personalized cancer care for pancreatic cancer and other aggressive cancer types. 

Loss of muscle volume is a common debilitating outcome of traumatic orthopedic injury, resulting in muscle weakness and loss of limb function.  The current best solution is muscle graft but a new therapeutic approach uses small pieces of autologous muscle which can be expanded in a collagen hydrogel and used to regenerate functional muscle at the sight of injury.

A study demonstrating the feasibility of using autologous minced tissue grafts for muscle regeneration shows it would be better for repairing large areas of muscle loss.  

More than 100 drugs have been approved to treat cancer but predicting which ones will help a particular patient hasn't really been possible.

A new device may change that. It is an implantable device, about the size of the grain of rice, and can carry small doses of up to 30 different drugs. After implanting it in a tumor and letting the drugs diffuse into the tissue, researchers can measure how effectively each one kills the patient's cancer cells. Such a device could eliminate much of the guesswork now involved in choosing cancer treatments, says Oliver Jonas, a postdoc at MIT's Koch Institute for Integrative Cancer Research and lead author of the paper in Science Translational Medicine.

Testosterone replacement therapies are controversial in males so extending it to females will likely be even more so. But research involving mice suggests an association between low levels of androgens (which includes testosterone) and atherosclerosis and obesity in females. 

Cholesterol-lowering statins have transformed the treatment of heart disease. But while the decision to use the drugs in patients with a history of heart attacks and strokes is mostly clear-cut, that choice can be a far trickier proposition for the tens of millions of Americans with high cholesterol but no overt disease.

Now a report from preventive cardiologists at Johns Hopkins and elsewhere offers a set of useful tips for physicians to help their patients make the right call.

The report, published March 30 in the Journal of the American College of Cardiology, combines the experts' collective clinical wisdom with previously published research on the benefits and potential downsides to long-term statin use.

A 3-dimensional model of human respiratory tissue has been shown to be effective for measuring the impact of chemicals, like those found in cigarette smoke or other aerosols, on the lung. 

More effective lab-based tests are required to reduce the need for animal testing in assessing the toxicological effects of inhaled chemicals and safety of medicines. Traditional lab-based tests use cell lines that do not reflect normal lung structure and physiology, and in some cases have reduced, or loss of, key metabolic processes. 

I just came back from Boston and the annual meeting of BAARN – the Boston Area Antibiotic Resistance Network symposium held at the Broad Institute.  The meeting was interesting but the atmosphere was funereal. Many of those losing their jobs with the closure of Cubist’s research center in Lexington, Mass were there as were many whose jobs are threatened at AZ’s facility in Waltham, Mass.

One major topic of discussion during the breaks was – where will all the antibiotic research go?
An examination of clinical trials covering more than 95,000 patients has found that glucose or sugar-lowering medications prescribed to patients with diabetes may pose an increased risk for the development of heart failure in these patients.

Heart failure is a common occurrence for patients with type 2 diabetes and has a major impact on one's life expectancy and quality of life as well as representing a major driver of health care costs. Overall, the study found that for every one kilogram of weight gain attributed to a sugar-lowering diabetes medication or strategy, there was an associated seven percent increased risk of heart failure directly linked to that medication or strategy.  
Academics have written a lot of articles claiming their competitors in the private sector selectively publish trials that favor their own interests don't care as much about transparency as academia, but is that really true? 

When it comes to investigational drugs, devices and biologic therapies, the data is available and it shows that industry was actually 3X more likely to comply with legal requirements than academic studies after disclosure was mandated. 

Leaky blood vessels in the lung can lead to acute respiratory distress. Shutterstock

By Jalees Rehman, University of Illinois at Chicago