I do think that maintaining the budget of a clinical study could lead organizations to conduct the studies in developing countries to save on costs. Balancing funding with results might not be easy since it could be difficult to plan a clinical protocol that will for sure produce a significant evidence without going over budget. By conducting studies in developing countries, maybe the organization can afford 20 surgeons in the study and obtain at least 15 will produce meaningful and supportive data for the product, whereas in the U.S you might only be able to afford 5 surgeons to participate in the study.

I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would probably be. For example, a researcher interested in conducting a study focused around the ZIKA virus would be much better off in a South American country like Brazil, where the disease is much more prominent and they can find a target group much easier.

I don't think it's possible because yea cost is a factor but it has to make sense. If the study is focused on a disease that predominantly affects that area yes but if it doesn't I doubt it. My company was working on a drug for a disease common in people from Asian defeat especially Chinese. So they set up a study there but we still had to have CRAs set up, send our scientist here and there and even send samples back and forth.

I agree with the statement above that the clinical trials may be conducted depending on partially where the disease may be more prominent but the secondary is also the cost. This cost can be whether the company is directly managing the different sites or acts as a sponsor and has a CRO that performs the entire process. In addition, depending on what regulatory body the company is trying to get approval, there may be specific requirements to get the device tested to affect the certain population.

The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2 because manufacturers of medical products have pursued a number of options to reduce cost, including the use of data from sites outside of the US. Depending on the site and the cost of care in the specific location, a clinical study conducted outside of the US can result in possibly in savings of approximately 50% or more. Additionally, the use of outside clinical data to support FDA submissions can save a company time. For example, in the US, some studies that present a large risk to human subjects require prior FDA approval and IRB approval. For products that obtain CE marking prior to FDA approval, the process of starting post-CE mark studies would certainly be a faster process than obtaining IRB approval or other US pre-clinical approvals. As other students mentioned below, there are many other factors to also consider before deciding whether to use foreign clinical data to support FDA submission.

Great topic, and I read an article with regards to shifting clinicial trials to third world countries because of the cost and the not as stringent regulations in other countries.
http://theconversation.com/ethics-vs-economics-the-cost-of-outsourcing-clinical-trials-to-developing-countries-43246

Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the article listed below, India has become a popular location in conducting these clinical trials due to the cost, about 20-60% if done locally.

https://ethicalnag.org/2011/07/10/clinical-trials-outsourced-oversea/

That is a little scary to me as cost shouldn't really be an issue in a clinical trial over quality. Not saying that the quality will be bad in other countries but it is a risk that is being taken either way.

The costs should not be the major determining factor in determining the location as to where clinical trials are held. Organizations should be putting their main focus on as to which location is relevant to their study or would allow for the research to be completed successfully. If they put more emphasis as to which location would be most cost effective, that does not necessarily ensure that the study will be done with the best results. As others have mentioned, if research is being done into a certain disease, it would make sense to have the study done in a location that has shown evidence to this disease, whether it be an expensive or cheap location. I do not think that organizations put the cost as the main aspect when considering locations for the study. The organizations look more into which location would make more sense for the study being done and if there is multiple locations, then maybe they will consider which one is more cost efficient out of all of them.

The clinical trials for new medications take place all over the world, but developing countries often serve as cost effective locations.  The developing country has a lot of people who are more likely to want to be in a trial. It’s getting harder to recruit people in America to trials.In United States is just more costly to try to find subjects, in terms of buying media and talking with doctors. High levels of poverty and illiteracy, combined with an almost blind faith in Western medicine, provide an almost endless supply of volunteers in countries .In developing countries injury or death as a result of misconduct is hard to prove and even harder to prosecute. clinical trials costs are largely driven by labour, much of these savings are from lower salaries to physicians, nurses, and trial coordinators.The time and cost of developing drugs influences the final product cost and return on investment, so the logic of reducing trial costs is clear and reasonable.

Executing a clinical trial can take large budgets to complete. To compete with this, companies tend to use developing countries as their regulations are less strict or even non-existent. The location of these trials makes a difference, however. For example, if it is in an area with unsafe water for consumption and the clinical trial requires water, the results could be skewed or not even be conclusive. While it does save money, companies still have to maintain all of the necessary safety measures to ensure that every subject is treated humanely.

clinical trials costs are largely driven by labor, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. It is true that some regions of the globe are vastly more expensive than others to conduct clinical trials. For example, a clinical trial in India can cost one-tenth of the price that it would cost in the US. However, the Risk of low quality in the other countries could be a pitfall for your clinical trials. I think clinical trials should not be about running inexpensive trial sites to benefit distant people, but should focus the quality and the results more than the cost!

I agree with many have already stated-that you want to make sure you maintain the quality and integrity of the study and not focus just on the cost. However working at a hospital, I know that budget is a big part of determining if/where a clinical trial will be done. At Sloan we are located in Manhattan so as you can imagine our IDC (indirect costs) rate is very high as compared to hospital in Nebraska for example, however if we have world class physicians and an oncology focused patient population, so we have a large volume of clinical trials conducted at Sloan. We have both investigator initiated trials and sponsored trials. We also take part in a lot of multi-center trials. I agree that patient population, PIs conducting the trial, location, and cost are all important factors when contemplating a clinical trial.

I agree with the comments above that costs are a major consideration when outsourcing clinical trials. When there is a discussion about cheaper costs in other countries, there is also a concern about the quality of work/materials. Just to expand on this discussion, I just read an article for final FDA rule will requires medical device trials outside US to conform to GCP. This year the FDA finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
Some change highlights from the final rule include:
• The new rule requires that sponsors and applicants provide statements and information about how their clinical investigations conform with GCP.
• The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the US to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs.
www.raps.org/ news-and-articles/news-articles/2018/2/final-fda-rule-requires-medical-device-trials-outs