Around the holidays, I reminisce about family dinners: three generations under one roof for a few hours, catching up on the past year. My mother presided over the festivities for several decades until her passing. For 10 years, she was a survivor of a rare cancer. She had two surgical resections and treatments before the cancer returned. There was only one approved orphan drug, which was 50 percent effective in decreasing mortality for six months. There weren’t many options in clinical trials and no Internet patient-centric community for information and support.
Leading a clinical trial at a research site as an investigator is a challenging task. Running a successful study requires the ability to manage budgets, coordinate the activities of support teams, efficiently allocate limited time and resources, and navigate the complexities of regulations and reporting obligations.
Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.
Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).
Wall Street is wondering what’s next on Amazon’s shopping list, and pharmaceuticals may be a leading contender. Here are four patient touch points where Amazon can leverage its existing capabilities in conducting clinical trials and pharmaceutical development.
Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.
With the age of remote clinical trials upon us, it bears asking: What do these trials mean for the common business-related tasks of clinical trials? One under-emphasized place of change will likely be investigator site budgets.
As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.
How has the U.S. Food and Drug Administration (FDA) responded to the increasing interest in patient diversity in clinical trials?