Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.
In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.
Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.
Pharmaceutical and device manufacturing companies often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. When doing so, these companies have a regulatory obligation to oversee the activities and quality of their vendors. However, vendor audits conducted by these companies can yield a wide range of results due to differences in auditors, scope, and understanding of PV principles and operations.
This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.
Part one of this series is intended to give readers a glimpse into what RWE is today, with its potential to utilize staggering volumes of data, digital health technologies, and mobile applications.
Our global digital population — people around the world that are active internet users — has grown to 4.3 billion as of July 2019, representing roughly 56 percent of the global population. Of this global digital population, almost 4 billion are accessing the internet using mobile devices, with non-tablet mobile devices contributing nearly half of web page views worldwide.
Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it? Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter). In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process. Let’s take a look at some of these key, yet often forgotten, areas.
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.