In our country, the volume of clinical trials is quite low. Despite the favorable conditions (shortening the time for obtaining approval and bureaucratic barriers), the sponsors (represented by reputable pharmaceutical companies, etc.) do not want to finance the conduct of clinical trials in our country. How to interest and (or) force sponsors (pharmaceutical companies, etc.) to invest in conducting clinical trials in the country?
The Pharmacodynamics (PD) based clinical protocol design in human (or animals design) for Single Drugs or for Drug-Combinations have been fully illustrated. (e.g., Chou TC et al Synergy, 9 (2019) 100049). For more details please see attached PDF slides). from TC Chou,m 2.25.2020)
You cannot force any company to invest in running a trial in the specific country. In terms of drawing their interest, reducing formal barriers (e.g. shortening time to obtain approval, reducing the bureucratic obstacles) is only partial (yet important) asset, they need also to be sure e.g. of the quality of the data obtained.
You have two questions here. ONe is: can I force Pharma companies to do studies in my country? The answer to that is: “Yes, if your country is large enough to impact sales perspectives if the company is ultimately refused marketing authorization”. But as you will probably understand, this is a self-defeating path.
The second question is whether sponsors can be induced to do clinical trials in your country. The answer is: “Yes, as long as it makes sense, economically”. The costs of starting and monitoring a site in Kazakhstan are likely to be much higher than one in (eg, the EU) due to distance and other logistical aspects (importing investigational product not being the least of them).
It’s an uphill battle and I wish you well but untill more regulatory alignment is in place, there is little hope of improvement.
Best wishes.
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