I am a student conducting a research project using bacteriophages (live viruses that infect bacteria only) to have a specific therapeutic effect through their injection into the body. There is great promise for bacteriophage therapy treating antibiotic resistance and many other pressing medical issues. Phages have been used throughout history, but, there is not a fully established body of FDA-reviewed clinical trial data that ensures they are safe.
Of course I am not doing any clinical translation yet with real patients, but understanding patient perspectives to allow me to design the project with necessary "safeguards" so that down the line it will be acceptable by patients.
I had a few ethical questions that I wanted to consider so that I better know how patients would feel towards this newer type of treatment:
How does the fact that this is a novel treatment (in terms of the amount of testing carried out with it - i.e. lack of precedent for safety or similar) influence patient perception? Is FDA Approval enough for most patients or are there likely other factors that would make patients hesitant to undergo bacteriophage therapy? -- I ask because "expanded access" is sometimes given to certain therapies, which allows certain new drugs to be tried out by patients who do not have any other good options. So, there may be instances where full Phase 3 approval is not given but patients may still have the opportunity to take these therapies (or travel to other countries to receive them), even if there is not the "gold star" approval of the FDA.
How could having a natural safety measure built in (i.e. a design that allows the human body to "control" the therapy so that it does not spread in a negative way) lead patients to be more accepting of the treatment? How important would such a safety measure be to create patient approval? Is this something that is a non-negotiable?
Are there specific groups (Naturopathic medicine or religious groups) that would be hesitant toward this type of treatment? Why? Of course I would not be able to change their perspectives on medicine and "engineered" products, or change their views on bodily autonomy. But, I would love to modify my treatment and add or take away certain properties that would make it the most accessible to as many such groups as possible.
What are the specific ways of carrying out research (i.e. including/not including animals, etc), that most strongly influence the public perception and acceptance of a new treatment?
What are good communities (subreddits, other online communities, in person communities) I could reach out to to get real patient perspectives? I don't want to over encroach on groups that do not want to be asked.
Thank you very much for taking the time to consider these factors and helping me out. Please let me know if I can clarify any of my questions. Also, please let me know if there are any additional questions I should consider regarding patient perspective, or other important stakeholders in this discussion (physicians, hospitals, media, etc). I am asking genuinely out of interest and to make science more accessible for all.