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Could Diversity in Clinical Trials Be the Key to Understanding Liver Disease?

In a New Yorker article about how evolutionary psychology findings are usually based on surveys of undergraduates, Anthony Gottlieb wrote, “American college kids, whatever their charms, are a laughable proxy for Homo sapiens.”  Biomedical research can suffer from a similar bias: Subjects don’t always represent the full range of patients in terms of gender, race and ethnicity. But why is it important to have diversity among subjects in clinical trials? One benefit is that involving a diverse...

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Patients as Partners in Developing New Medicines

With a growing emphasis on patient-reported outcomes, study volunteers are becoming active participants in evaluating a treatment’s efficacy. Since the first reported controlled clinical trial in 1747, when Scottish surgeon James Lind studied how eating oranges and lemons can cure scurvy among sailors at sea, patients have always been essential to expanding medical knowledge and developing new therapies. After all, no one knows your body like you do. But for the most part, patients have been...

Predictive Modeling in Clinical Trials: A Data-Backed Crystal Ball

In the business world, financial modeling has long been the go-to tool to predict the future performance of a company or investment. Now with the growing availability of big data, the pharmaceutical industry is increasingly turning to predictive modeling for a variety of tasks, from identifying new molecules for drug targets to forecasting clinical trial timelines.   For Mohanish Anand, Executive Director, Head of Study Optimization at Pfizer, predictive modeling is the bread and butter of what...

Artificial Intelligence: On a mission to Make Clinical Drug Development Faster and Smarter

Just as Industrial Revolution-era factory builders developed machines to mass-manufacture drugs once ground by hand, today’s pharmaceutical companies are turning to artificial intelligence (AI) to both speed and smarten the work of clinical development. AI could assist pharma companies in getting medicines to market faster. AI today not only does flashy gene-sequencing work, it’s being trained to predict drug efficacy and side effects, and to manage the vast amounts of documents and data that...

Drug Makers Recruit Patients With Specific DNA for Precision Medicine Trials

Precision medicine is an evolving field focused on bringing more precisely targeted medicine to more precisely targeted patients. The goal is to identify specific subgroups of patients, and match them to a customized treatment that potentially could be transformative. Advances in genetic analysis, the use of AI to analyze patient data, and new drug discovery techniques are making precision treatments much more possible to develop and deliver. But there’s a huge hurdle between research lab and...

Getting a Medicine to the Brain Is a Major Challenge in Drug Design: How This Scientist Solved It

For cancer patients who have been treated with a particular medicine for some time, one of the hurdles many of them face is the tumor developing a resistance to the medicine. It’s a cruel twist that can affect patients being treated for non-small cell lung cancer, which can mutate and begin attacking the brain.  Lung cancer accounts for most cancer-related deaths in the U.S., with non-small cell lung cancer being the most common type,, so the scope of the problem is broad. But if lung cancer...

Decoding the Mind-Blowingly Complex Logistics of Supplying Experimental Medicines for Clinical Trials

Ever wonder how researchers keep human bias out of clinical trials? Or how the millions of units of experimental medicine that go to patients all over the globe are tracked? It starts even before the medicines are shipped out. For any major pharmaceutical company that provides potential medicines to hundreds, or even thousands, of clinical trials being conducted all over the globe at any given time, the complications of the task are truly staggering. Not only do the potential medicines have to...

How the Placebo Effect Can Cloud Clinical Trial Results

When researchers design a clinical trial, they can’t ignore the powerful—and often bizarre—placebo effect. Since ancient times, healers have known the power of the mind-body connection — specifically, the mind’s ability to influence how the body feels. This influence can at times be so strong that the treatment doesn’t even have to be “real” for the patient’s symptoms to subside. This is the placebo effect, and it’s a very real phenomenon, both in the lab and in the doctor’s office. In fact...

‘Bucket Brigades’ Gone Rogue: A New Path to Shutting Down Cancer Growth

A critical pathway in our cells acts like a bucket brigade, efficiently passing on signals that control cellular growth. But what happens when one set of “hands” on the line goes rogue? The mitogen-activated protein kinase (MAPK) pathway is a chain of proteins that relays signals from outside the cell into the nucleus, controlling cellular growth and death. When this essential pathway malfunctions, it may lead to more than just chaos—it may determine how cancer progresses. If one of these...

How a Former Neuroscience Researcher Is on a Mission to Close the Diversity Gap in Clinical Trials (Q&A)

  When the Food and Drug Administration (FDA) recently gave a presentation on diversity in clinical trials, Dr. Ricardo Rojo wasn’t surprised to hear that — at least for medicines where gender is not overtly relevant — research participants today are predominantly white men. Rojo, Pfizer’s first Global Lead for Diversity in Clinical Trials, is on a mission to change this. For years, the FDA, the pharmaceutical industry and various stakeholders have been working to improve racial, ethnic and...

How Preparing a Drug for FDA Approval Requires the Mind of a Scientist and Strategist

Regulatory experts draw upon both scientific and strategic thinking to shepherd new drugs to the finish line. Every drug that is prescribed by a doctor must first be approved by the Food and Drug Administration (FDA) or its regulatory counterparts in Europe, Asia and around the globe. If a drug is successful in clinical trials, then a New Drug Application (NDA) is submitted to the regulatory agency, where it undergoes a final approval process that can take up to a year.  But regulatory experts...

The Action-Packed Search for Stability: A Breakthrough in the Fight Against RSV

Respiratory syncytial virus (RSV), a major global childhood infectious disease without a vaccine, kills approximately 120,000 infants a year worldwide. It’s the most common reason infants are hospitalized. Additionally, RSV sickens millions of elderly people each year.When most people catch RSV, they get a mild cold and recover quickly. But some — especially infants and the elderly — can get very sick. Infants can develop pneumonia or bronchiolitis, an inflammation of the small airways in their...