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Compliance In Focus
Posted by John Lehmann on Fri, Dec 14, 2012

Running a Clinical Trial Outside the US? Be Prepared.

Running a Clinical Trial Outside of the USHalf the battle when facing obstacles or challenges is proper preparation. Knowing what types of challenges you may face is one way to ensure you have a well-thought out plan for the situation. So much opportunity exists around the world and as of late it has been an industry trend to operate studies outside the US.

Recently MD+DI published an article, “Study Abroad: Tips for Successful Clinical Trials Outside of the United States”. This article touches on the barriers that exist but also the many benefits that are present- if you’re prepared! We’ve summarized some of the challenges of running clinical trials in emerging markets:

  • Time and Distance:
    • When distance is an obstacle having great communication skills is key. Keeping in close and constant contact will help everyone remain on the same page and allow time to discuss questions.
    • Another challenge can rest in the time zone differences. Some countries have a 4-8 hour time change then the US and that definitely can shift the working day. As the article says, “be prepared to work at odd hours. Somebody is always up early and somebody is working late.”
  • Customs
    • There can be difficulties in navigating clinical trial necessities through customs which can result in delays. Be prepared to handle export and import challenges.
    • Even traveling to different countries can present obstacles. Even traveling from the US to Canada can be a time consuming measure when customs is involved. Know the rules in each country beforehand.
  • Cultural Differences and Language Barriers
    • Is English the primary language of the emerging market? What are the English literacy rates? These are good things to investigate up front.
    • As the article points out, “Cultural differences are always present. A company must be prepared to work with its CRO to ensure that all parties participating in its trials understand what is being asked of them, agree to the protocols and come up with realistic timelines so that there are no surprises and minimal misunderstandings.

Check out the full article on MD+DI and learn the tips for a successful clinical trial out side of the US. Being well prepared upfront is crucial for an efficacious study. The article points to a main key when getting started:

No One Size Fits All Solution. It’s important to note that a medical device company should select a CRO that has experience with medical technologies and not just pharmaceuticals because the trial process and requirements are vastly different.”

Choosing the right CRO is key. Stay tuned, next month IMARC is releasing an infographic to help those in search of a CRO as to which points should be addressed in the decision making process.

Let us know your thoughts on operating clinical trials outside of the US. Do you think running studies in emerging markets will be the future for the medical device industry? Feel free to share your thoughts below.

Photo Credit: davidrossharris

Significant Risk/Non-Significant Risk Determination

Topics: Overseas Clinical Trials, Clinical Research, MD+DI

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