The cost of running a clinical trial includes numerous factors. Here is a partial list of issues I can think of at the moment.

Can the test material be produced in a reproducible manner using good manufacturing practice (GMP), at sufficient scale, and with sufficient documentation to satisfy the regulatory agency requirements? These necessities will be particularly challenging to accomplish with a complex mixture such as a plant extract.

What is the precise patient population that you intend to treat in phases 2 and 3? What specific medical conditions must they have for inclusion in the trial, and must they NOT have?

What is the comparator drug? It must be a drug that is normally used to treat the infection(s) under study (i.e., the standard-of-care), if there is anything. How many patients will your trial need to demonstrate non-inferiority to the comparator with the negotiated (with the regulatory agency) level of statistical significance.

How many clinical trial sites will be needed to accumulate enough patients in a reasonable time-frame? What countries are they in? Who will go to those places to set things up for the trial?

Who will collect the patient samples, isolate and characterize the infecting microorganisms?

Who will be overseeing the trial in each site? Who will collect and collate all the documents?

How will the test article be distributed and stored? Is it sensitive to light?How long is its shelf life?

Will special training be required of clinical staff to use it properly? How often and by what route will it be administered to patients? If it is to be administered IV, has it been tested for stability in the specific type of IV bag that will be used?

When thinking about potential revenues, consider the unmet medical need for the new drug. How many other drugs are already available to treat the same condition(s)? How serious is the problem of clinical resistance to those drugs? The price of the new drug, if set too high, may discourage its use in favor of older drugs, even if the older drugs don't work as well. If the price of the new drug is not set high enough, it may be unprofitable to manufacture and distribute.

Adam B Shapiro Thank you for your insightful questions regarding my antibacterial formulation project.

I would like to clarify some important points:

Regarding the final product, I can confirm that it can be produced under Good Manufacturing Practice (GMP) standards with respect to its physicochemical properties. The plant component can be cultivated specifically for this purpose, ensuring a consistent supply of raw material.

My studies have shown promising results for this combination against multidrug-resistant bacterial strains. Importantly, the antibiotic I've combined with the plant extract is considered a last-resort antibiotic that typically induces nephrotoxicity. However, our key finding is that the addition of this plant extract not only enhances the antibacterial potential against resistant strains but also significantly reduces or eliminates the nephrotoxicity of the antibiotic.

The target population would be patients infected with multidrug-resistant bacteria who would otherwise require treatment with nephrotoxic last-resort antibiotics. This addresses a significant unmet medical need while potentially reducing treatment complications.

I appreciate your continued guidance on estimating clinical trial costs and potential revenue projections, particularly in the Algerian context.

Best regards,

Participating in a Phase IV clinical trial costs more than $4,200 for one patient. A small suggestion is to use Microsoft's online Power Automate to implement random grouping and allocation concealment, which can save money on the random grouping system. I hope it helps you.