In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.
Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.
There are over a quarter million active clinical trials registered with the FDA right now, up from just 1 percent of that figure at the turn of the century. It’s a $65 billion industry – clinical trials alone, that is, and it’s only going to get bigger.
Many workplaces are composed of five generations, from traditionalists to Generation Zs. While this can lead to a host of communication, productivity, and other issues, the challenges are perhaps never more apparent than with the introduction and use of new technologies. In fact, this has led some to claim age isn’t the deciding factor when it comes to describing how proficient people are with digital technologies and culture.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”
There has been an increasing and requisite focus on the needs of individuals affected by chronic or life-limiting disease, which has in turn resulted in a focus on the development of possible interventions and how they are administered. The success of participation and retention of these patients in clinical research, advancement of the drug development process, and adherence post-commercialization require the involvement of another critical expert — the caregiver.
The current approach to clinical trial recruitment is prolonged, costly, and inefficient and often causes major delays and challenges for research across multiple disease states. The vast majority (85 to 90 percent) of studies in the U.S. experience significant delays in recruitment and enrollment. Nearly one-third of trials under-enroll, and only 7 percent meet their target enrollment number on deadline.
Clinical research associate (CRA) turnover has long been a complex and challenging issue. We can recruit more CRAs, increase publicity in colleges, and introduce assessment standards. I could quote various statistics regarding turnover, but I won’t.
While risk management as a concept has always played a role in the clinical trial space, there is increased pressure to identify and manage trial-related risks more systematically. This article discusses six important considerations when making the decision to utilize RBM as part of your operational growth strategies.
Pharmaceutical companies have three targeted users: physicians, pharmacists, and patients. Various digital platforms are used to create a good customer experience for educating these end users. The core focus is on patients driving patient care, education, and adherence.