If you’re thinking about conducting MPN clinical trials, there are a few things that you need to know. The first is the legal and ethical considerations for these . This post will cover some of the most critical aspects of these considerations so that you can make an informed decision on whether or not this is suitable for your next trial.
1) What is MPN?
MPN is a medication that is effective in the treatment of cancer cells. MPN trials are conducted on patients who are already being treated with MPN for their cancers. They study how MPN reacts when used with other medications or treatments.
The FDA grants approval for MPL if it fulfills these three criteria:
- MPL is reasonably safe and effective for use based on scientific evidence
- MPL has an active ingredient that cannot be obtained by any other method
These trials have been conducted with the new indication showing no significant safety, purity, or potency problems. (FDA)
2) What type of MPN studies does my company want to conduct?
- They are conducted on patients who are already being treated with MPN for their cancers. They study how MPN reacts when used with other medications or treatments.
- MPL studies can also be done in healthy volunteers to test MPL’s safety. These types of “Phase I” tests usually include a few hundred volunteers.
- MPL studies are also done in patients who have other cancers or conditions to learn how MPN will affect people with different illnesses (Phase II).
- Phase III trials may include thousands of subjects and test MPL’s effectiveness, safety, and optimal use among groups of people to make sure MPL is safe and effective.
3) How do I get approval from IRB (Institutional Review Board)?
An MPL study can’t be conducted without IRB approval. An MPL clinical trial is considered “human subjects research.” It requires an Institutional Review Board (IRB) to approve it before the study begins, called “IRB review.”
- For any MPL studies involving human subjects, investigators will need to submit a detailed protocol to the IRB for review. These trials will not be started without IRB approval.
MPN studies are conducted by teams of doctors, nurses, and other healthcare professionals who work together to give MPL when it’s the proper treatment for you.”