Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Complex, Puzzling, Ill-Defined: Challenges in Assessing PTSD

A recurring challenge in assessing and treating Post-Traumatic Stress Disorder or PTSD is the inherently complex, ill-defined, and sometimes downright puzzling nature of its symptoms. The condition has had many names over the years. Among them: shell shock, combat exhaustion, irritable heart, and even nostalgia. The affliction, now widely know as post-traumatic stress disorder, was...

Applied Clinical Trials – Alzheimer’s Clinical Trials: Obstacles and Opportunities

Dementia is a global epidemic, affecting nearly 50 million people worldwide. By 2050, it’s estimated that 115 million people will suffer from some form of dementia. Alzheimer’s disease (AD) is the most common type of dementia occurring late in life. AD is also the only condition among the leading causes of death that cannot currently be...

Conducting Clinical Trials in the Asia Pacific Region: Opportunities and Obstacles

Global clinical trials are projected to exhibit a compound annual growth rate of 12.4 percent and reach revenues of $57 billion by 2020, according to a recent report by Frost & Sullivan.[1] As the cost and complexity of drug development continue to increase, the Asia Pacific (APAC) region is a key destination for the conduct...

DMC? CEC? Your Guide to Translating Clinical Trial Shorthand

We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,...

Four Things You Need to Know About mHealth and the Dermatology Field

Advances in medical technology have opened the door for dermatology mobile health (mHealth) programs, and these same technologies have the potential to radically change dermatology trial designs. Here are four ways digital disruption in the dermatology field is benefiting both patients and providers: 1. Reduced wait times: Digital health assessments make time spent scheduling, traveling,...

Premier Insight 267: From KOLs to Patient Advocates, Using Every Tool to Fight a Rare Disease

Finding patients for trials in very rare conditions is difficult under any circumstances, and in this case the odds were really stacked high against success. The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The...

Finding the Fast Track in Early-Phase Oncology Trials

Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical data...

Pharmaceutical Executive – Small Biotechs Gain As the Span of Clinical Trial Outsourcing Grows

A customer approached me recently for advice on hiring a chief medical officer. My answer: “Don’t.” The last thing his two-person company needed was to spend a lot of money increasing its staff by 50% and still not achieving its real objective. Not that there’s anything wrong with CMOs—I am one, after all—but tiny, virtual...

Making the Case for Long-acting Antipsychotic Treatment

Medical science is making significant advances in treating schizophrenia, but for all the progress we’ve seen, patients don’t benefit much unless they regularly take their medications. Second-generation (or atypical) long-acting injectable antipsychotic treatments (LATs) that ensure consistent administration of medication have become widely available over the past 15 years, but they remain a tough sell...

PM360 – Maximizing the Probability of Trial Success for CAR-T Cell Therapies

CAR-T cells are complex products, and translating them from basic and preclinical research to clinical trials and commercialization can be challenging. Understanding the regulations and developing a protocol that puts safety first—at every stage of development—are important first steps in bringing promising CAR-T cell therapies to the patients who need them most. CAR-T Cell Therapies:...