Where should we hold clinical trials?

NickOttens

We have identified four criteria for deciding where to hold clinical trials:

1. Recruitment speed: Depends on the number of suitable, experienced sites that can be activated as well as the availability and cost of health care.
2. Study cost: Expenses of labor and site fees.
3. Regulatory environment: Regulatory requirements differ between countries.
4. Investigator motivation: Motivation of sites and PI to participate and contribute to a clinical trial.

In Georgia, it only takes 6 weeks to get approval.

In Bulgaria, Colombia, Estonia, Latvia, and Lithuania, it takes 8 weeks.

In Ecuador, it takes 4 weeks to obtain approval from an ethics committee and 
6 more weeks to obtain approval from the ARCSA - MoH.

In Peru, it 6 weeks to obtain approval from an ethics committee
, 1 week to obtain approval for protocol from INS
, and 8 weeks for the INS review and approve the clinical trial.

In Chile, approval from an ethics committee takes 13 weeks and approval from the ISP 6.5 weeks.

Malaysia markets itself as a preferred clinical trial destination. Regulatory and ethics submissions are in English. Patient costs and IRB fees are low compared to most countries. The average timeline for regulatory and IRB approval is about 3-4 months.

Which countries do you think we should consider? Are there criteria we should add, or change?

NickOttens

@taboma, @dives86, @dalminana, I'd like to ask your take on this. Which countries do you think we should consider for clinical trials?

@nicolas_cher, would you recommend Brazil?

NickOttens

@joannabensz, do you know how easy or difficult it is to hold clinical trials in Poland?

NickOttens

@nastyahaut, @poulain, can you tell us more about the regulatory environment for clinical trials in Estonia?

dives86

@NickOttens lacking clinical trial experience myself, I would recommend reaching out to Bobby Brooke at Intervene Immune (driving the TRIIM trial, TRIIM-X trial) who has experience targeting multiple indications

NickOttens

dives86 wrote: »

@NickOttens lacking clinical trial experience myself, I would recommend reaching out to Bobby Brooke at Intervene Immune (driving the TRIIM trial, TRIIM-X trial) who has experience targeting multiple indications

Great minds think alike! Our team is in close touch with Bobby.

nicolas_cher

@NickOttens , about Brazil, I really don't know the details about how it works here. However, I know that right now Brazilian currency is very devaluated, so it would be relatively cheap, compared to other times in the past.

NickOttens

Thanks, @nicolas_cher!

@YuriDeigin, @sramek, @CarolynPorter, can I ask for your input on this question as well? What's the best country to hold clinical trials?

mashizaq

@NickOttens I guess an African country like Kenya stands a good chance. The vibrant weather and quality of healthy food lifestyle can be a factor to consider for more positive results.