Early Access Programs allow patients and physicians to use investigational (pre-approval) drugs outside the clinical trial setting. They are often referred to as Expanded Access Programs (EAPs), Compassionate Use Programs (CUPs), or Managed Access [...]
Expanded Access Programs (EAPs) provide patients access to investigational drugs outside of the clinical trial setting. These programs provide promising new medicines to patients suffering from cancer or rare diseases who have no other [...]
In recent years, industry has been looking for ways to modernize the traditional clinical trial model. As such, companies are now being encouraged to try methodologies and strategies that will streamline processes and introduce [...]
Compassionate use is a term used to describe the provision of an unauthorized medicine when it is given to a patient at no cost. This usually occurs when a drug company recognizes there is [...]
Compassionate use refers to the use of an unapproved drug to treat a patient, outside of a clinical trial setting, when no other viable treatment options are available. Compassionate use can also be referred to [...]
After Right to Try legislation was passed in the US earlier this year, many believe that desperate patients will now find it easier to try investigational products outside of the clinical trial setting. However, like [...]
Patients suffering from rare diseases or life-threatening illnesses, like cancer, can often find that there are very few treatment options available to them. For these patients, accessing an investigational drug outside of the clinical trial [...]
Recently approved legislation, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”, allows patients in the US the ability to request access to investigational drugs, without any approval [...]
Randomized controlled trials (RCTs) have long served as the gold standard for developing and assessing new drugs and devices. However, over the past couple of years, there has been a real push towards collecting and [...]
