How to Conduct Foreign Clinical Trials

For several reasons, the US pharmaceutical and biotechnology companies are conducting most clinical trials outside the United States. Some say research cost is reduced by more than 50 percent when taken outside the USA, which allows companies and their investors to see a bigger profit. Other reasons for going outside the USA are better patient recruitment exists for “naive populations” (i.e. people who are not taking a lot of medication). This will allow the sponsors to determine how well their potential treatment is really working without worrying about possible interference from other medications. Under the right circumstances, the United States FDA will accept data from foreign clinical trials. This article will provides some things to consider if you plan to conduct foreign clinical trials.

Difficulty: Moderate

Instructions

Things You'll Need:

• Basic knowledge of Good Clinical Practice and Human Research
• Money

1. Decide on where you will conduct the clinical trial.
   
   Multi-country clinical trials are a logistics nightmare for a sponsor or CRO’s Regulatory Affairs and Quality Assurance staff. Most likely, each country have regulatory requirements specific to their country and Regulatory Affairs and Quality Assurance are responsible for knowing them and guiding the company to meet compliance. Therefore, the sponsor need to decide where the foreign clinical trials will be conducted and immediately inform the Regulatory Affairs and Quality Assurance divisions.

2. Learn what is required and do it.
   
   Various requirements will exists and they must ALL be adhered. Most countries will require import certificates for the investigational product. Some require that the clinical trial also be conducted in the United States. (You only need one site with 1 patient and you’ve met this criterion). Almost all of them require a local scientific representative (i.e. medical doctor as a principal or clinical investigator) to monitor the clinical trial in their respective country.

3. Hire an experienced Clinical Research Organization (CRO), preferably a local one.
   
   Some countries, like South Africa, require the CRO be registered to operate in their country. (Personally, I think to deter some of the “here today – gone tomorrow” organizations in the US; Ethics Committees , Site Management Organizations and CROs should be required to register in the United States as well.). Therefore, prior to hiring a CRO to oversee clinical trial management, make sure they will meet that country’s regulatory requirement. An experienced CRO will be able to help with language barriers as well guide you on the regulatory submissions.

4. Dealing with foreign languages.
   
   The United States main language is English and the majority of the residents do not have a second language. Many countries uses different languages and different dialects. You are not expected to know all of them, however, if you plan to submit the clinical trial data to the Food and Drug Administration (FDA) for approval in the USA, the documents will need to be in English. Some documents that should be English include 1)proof of the Clinical Investigator’s qualifications, and 2)proof of investigational drug (product) shipment, receipt, and amount administered to volunteers are important and should be translated. Work with your Quality Assurance and Regulatory Affairs group to ensure the main documents are translated into English by a certified translator, per regulations.

5. Learn about and respect the culture.
   
   U.S. visitors to foreign countries should be familiar with that country's culture and language. For every country I visited, I made an effort to learn "Hello, Thank You, Good Morning and Good Evening" in that country's language. Just basic manners that we were taught since childhood - but I think the locals appreciate US visitors making an effort instead of expecting everybody to know English.

6. Include the country's regulatory requirements in the protocol.
   
   Some Regulatory Authorities find it offensive when US Sponsors write protocols for clinical trials in their country and only reference US Regulations and US FDA. Ensure you at a minimum mentions the name of the country in the protocol and refer to those countries applicable regulations. After all, you are using their resources and you are required to abide by their laws.

7. Validate clinical trial software.
   
   As technology evolve and companies switch to e-trials; it is important to determine if the chosen countries have the ability to access and utilize the clinical trial software and other electronic communications. Some countries experience periodic power outages and might not be able to receive faxes of clinical events and other transmitted material.

Tips & Warnings

• Always research the country's culture before adding them to your clinical trial list.
• According to the South African Gidelines on clinical practices, the clinical trial industry in South Africa has grown an estimated 40% or greater from
• 1997-1981 with an estimated yield of R826 million during 2000. (826,000,000 South African Rand = 105,601,616 US Dollar).
• Not all of the clinical trial growth in South Africa came from the United States.

Resources

• How to Choose a Good Clinical Research Organization (CRO)
• How to Coordinate a Successful Clinical Trial Collaboration
• How to Volunteer For a Clinical Trial

[kaseysviewblog]

on 8/18/2008 Really interesting info, Thanks.