Why do we need clinical trials?

Clinical trials are studies that determine whether a drug or device is effective at helping treat medical conditions. Every treatment available today will have undergone testing in clinical trials first. This is because the U.S. Food and Drug Administration (or FDA), and similar agencies in other countries, need to know it works and is safe before it can be prescribed or distributed for general use.

A day in the life of a clinical trial patient: Part two

Signing up a clinical trial can feel quite daunting. You may have questions about what the trial process is like, or want to know how other participants have gotten on first-hand. You’re not alone. We’ve put together a blog series to follow the “diary” of Mark Blyth, a fictional patient volunteer, to help give you a sense of what it can be like to participate in a clinical trial; this blog is the second installment.

COVID: The unmet needs being addressed by clinical trials

Thanks to clinical trials, significant advances have been made in our knowledge of how to prevent and treat COVID-19. Nevertheless, the disease remains a threat. That’s why a great deal of effort continues to be poured into vaccine and treatment research. Here’s a brief overview of that effort.

Personalized medicine and what it means for you

Personalized medicine is big news. But why are scientists and doctors so excited by it? Well, imagine being able to get a more accurate and faster diagnosis, and then being given a treatment that your physician can more confidently know is the best treatment option specifically for you. That’s why there’s so much effort going into developing personalized medicines and diagnostics.

NASH/NAFLD: Screening and Diagnostic Testing

The screening practice for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) depends on highly variable global guidelines. Screening refers to checking for a disease in the absence of symptoms. Early detection through screening increases the likelihood of successfully treating the disease. In the US, high-risk populations for NAFLD/NASH are screened through laboratory tests, imaging, and, sometimes, a liver biopsy to determine if they meet the criteria to be diagnosed with NAFLD or NASH.

NASH: Present and Emerging Treatments

Nonalcoholic steatohepatitis (NASH) is the second leading cause of liver transplantation in the United States. Since available therapeutic options remain limited, developing new therapies that can change the disease outcomes for people living with NASH is vital. This brief article will look at the current NASH management options and discuss new drugs in development.

Hypercholesterolemia: Causes and Management

Two in five Americans have harmful levels of cholesterol in their blood. Hypercholesterolemia, or high cholesterol, remains one of the significant risk factors for heart disease and stroke, two leading causes of death in the United States. Knowing how to prevent and manage the condition is vital, as there are almost no symptoms.

Clinical Studies and You

You may have heard of clinical studies, but you might not know much about them. Each medicine doctors give their patients must first be approved by a regulatory agency, such as the U.S. Food and Drug Administration (FDA) and similar agencies in other countries. Before this can happen, we need real-world evidence that a medicine is safe and that it is effective in the populations with disease. Sponsors (pharma and biotech companies) run clinical studies to gather the evidence and submit it to regulatory agencies who review the evidence and approve the medicine for patients, if it is safe and effective.

Diversity in clinical studies: Why it matters

People from different ethnic backgrounds may have a different response to certain medical products (medicines and medical devices) and that is why it is important for clinical studies to include people from all background and across different age groups, races and ethnicities.

Mental Health Challenges: Seasonal Depression and Anxiety

As fall begins, many people may start to experience symptoms of seasonal depression. In fact, about 5% of Americans experience symptoms of seasonal depression every year. It is essential to recognize these symptoms and seek effective treatment options.