What Are Some of the Potential Drawbacks to Receiving an Investigational Drug?
Although investigational drugs can provide hope for cancer patients who may not be responding well to standard therapies, there are certainly drawbacks and risks associated with the opportunity. The process is associated with a whole gamut of unknowns, some of which could potentially be dangerous. Investigational drug drawbacks include the following:
- Because the drug has not completely moved through clinical trials, it’s not certain that the investigational drug’s efficacy will actually outstrip the standard therapies currently on the market.
- There is no guarantee that any given patient will experience any benefits at all from the investigational drug.
- If the investigational drug is still in the early stages of testing, it’s unlikely that the entire spectrum of potential side effects will be fully understood prior to beginning the regimen.
- A patient’s health insurance company may not elect to cover the entire set of costs associated with the treatment.
Avoiding Risks With Investigational Risks
Although there’s no way to completely eliminate risks form the investigational drug equation, the protocols associated with actually obtaining said drugs can mitigate those risks. In particular, the minimum patient criteria for eligibility to receive an investigational drug can help narrow down the appropriate patient pool.
To be considered a candidate for receiving an investigational drug outside of a clinical trial drug investigation setting, physicians must establish that patients:
- Have gone through rounds of the standard treatments already on the market without any luck.
- Must be unable, for whatever reason, to join any ongoing or planned clinical trials for drugs appropriate for their particular cancer diagnosis.
- Have a cancer diagnosis for which an investigational drug product has already demonstrated an acceptable level of safety and efficacy. In most cases, this product must be currently studied in either a Phase 2 or a Phase 3 trial.
TD2 is a world-class drug development service that specializes in getting the most innovative oncology treatments to patients who have been let down by more traditional treatment options. We can help physicians fill out applications for patients to access investigational drugs and help doctors weigh the costs and benefits associated with a particular investigational drug for a particular patient. We can also provide information about important regulatory issues.