I am curious about the general level of knowledge about the process for developing new medicines.


For example:

-The three phases of clinical trials (phase 1, 2, 3),

-The process for informing participants of all the risks and potential benefits of participating in clinical studies (informed consent process) 

-Oversight of clinical trial participant safety by Institutional Review Boards (IRB) and FDA

-How much safety information is required by FDA and IRBs in order to advance to the next phase of research?

 

Also, how many people understand that new medicines for sickle cell can't be developed unless patients with this condition participate in clinical trials?

 

Is there a general awareness that all ongoing clinical trials (for SC and other illnesses) and the hospitals participating in each study, are published on clinicaltrials.gov ?

 

Thank you for considering these questions.  I am looking forward to hearing your thoughts, as well as suggestions for the best ways to share information around the medicines development process (web site, community meetings, webcasts/podcasts, etc.)

 

 

 

 

Views: 18

© 2024   Created by Ade Dotun.   Powered by

Badges  |  Report an Issue  |  Privacy Policy  |  Terms of Service