Patient-reported outcome measures are increasingly important in the assessment of treatment regimes, both for regulatory approval and for market access. However, selecting the most appropriate measure and interpreting the data can be challenging.
Governments have integrated incentives to accelerate and promote the approval of orphan drugs and the interest among pharmaceutical companies to develop these products is rising. However, expedited regulatory approval is by no means an assurance that orphan drugs will succeed in the marketplace.
Big data reportedly houses so much clinical and commercial insight that, once unlocked, it can increase our understanding of customers and markets, while also informing the design, development, and marketing of biopharmaceutical products and services. It can also drive positive health and economic outcomes. With tremendous volumes of data, companies have more resources (in the […]
On average, it is estimated that over 50% of patients eventually abandon their treatment. Patient-reported outcomes (PROs) could facilitate efforts to reduce these figures. Defined as any data coming directly from patients about how they feel or function in relation to a health condition or its treatment – with no clinician interpretation to remove the […]
There is a gap between scientific knowledge and daily medical practice. Although there may be major science breakthroughs, this does not directly translate into new treatments available to patients. New products from research and development can only be translated into medical practice if they are reimbursed by payers. In pharmaceuticals and biotech, there are two […]
Generation of real-world data is on the increase, from smartphones and social media to medical records and clinical trials. This wealth of data has a huge amount of potential, but in order to make the most of it, life science companies need to focus on generating the right kind of insights from the megabytes of […]
Drug prices are rising across the European Union, and in economically-difficult times this is having an impact on drug affordability and accessibility. The European Union health ministers have met to discuss the impact of the situation, and make decisions that could change the way that drugs are priced across the region. These conclusions were published […]
For parents of children with serious disorders where there is no approved treatment, or physicians who have tried everything for their patients with terminal diseases, the wait for approval of innovative drugs is a long one. The European Medicines Agency’s adaptive pathways pilot project aims to allow patients and their physicians to access life-changing or […]
EUnetHTA is a network of health technology assessment (HTA) bodies across Europe. This cross-border group aims to standardise evidence generation, and support decision-making by working together, in order to add value to the HTA process at regional, national and European levels. This will be achieved through the best use of resources, and by sharing knowledge […]
Real-world data is a vital part of market access today, and there are a variety of different sources of patient data to work with ranging from observational data collected from claims databases and patient records, through to some of the outputs from registries and monitoring platforms linked to accelerated approval processes. Data direct from patients […]