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April 6, 2016

Navigating the US FDA Regulations using OUS Data

Mary McNamara-Cullinane, Intrinsic Therapeutics, explains how to navigate US regulations when using Outside the US clinical data to support regulatory submissions

By Staff Writer

FDA Guidance on Acceptability of Clinical Studies Conducted Outside the US

On April 22, 2015, the FDA issued the Acceptance of Medical Device Clinical Data from Studies conducted outside the United States: Draft Guidance for Industry and Food and Drug Administration Staff. The guidance describes the current FDA policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. This is not a new policy but it describes the FDA's existing approach to handling clinical data outside the United States (OUS). There are several considerations that apply when using OUS data, including, applicability of the data to the intended patient populations within the US and study logistic recommendations.

Use of this guidance document in guiding the management of OUS clinical data is critical to successful regulatory submissions as it provides recommendations in developing data that are adequate under applicable regulations. The guidance reiterates well-established agency policies with respect to the acceptance of OUS data. It provides a high-level overview of the agency's analytic process for deciding whether to accept foreign clinical data, as well as several examples that illustrate the agency's position. It is all companies' best interest to meet with the FDA prior to starting an OUS trial.

Embarking on an OUS Clinical Trial

There are several questions that need to be asked prior to initiating an OUS Clinical Trial:

  • What are your clinical trial design needs and safety and effectiveness endpoints?
  • What is your initial regulatory submission?
  • Where do you plan to commercialize first? EU? Canada? Australia? EMEA? US?
  • What patient population, demographics and surgical or disease state will be studied? 60

It is vital companies take into account the differing cultural, scientific, ethical, and logistical issues present in each region. In emerging markets across the world, many governments are looking to invest in and conduct clinical trials in the hope of providing new therapies and technologies to patients who need them. In order to do this effectively, however, requires the use of innovative strategies designed to overcome the numerous challenges associated with clinical research in these regions. Global trials are necessary in today's world to find both hard-to-reach patients for rare disease studies and surgical/medical conditions. Drug and device developers will often find faster patient recruitment, operational cost savings, and expanded brand exposure for future technologies in OUS clinical studies. Conducting trials outside of the United States continues to pose a number of challenges, with activity in certain regions variable. However, with the appropriate design and oversight, these clinical trials, while accommodating both US and OUS regulations, can reduce costs and time to market.

Many of the challenges in clinical trial globalization can be overcome by ensuring the correct infrastructure is in place and logistic strategies are well planned. Using integrated clinical trial management systems when conducting trials is paramount in emerging markets. Electronic Data Capture Systems provide a seamless and efficient data collection method compared to trials run using various unrelated or manual systems. Working closely with OUS preferred vendors for sample evaluation or other testing in global studies is required for an effective clinical study. Use of outside CROs, in many cases, provides clear advantages since they have access to global infrastructure, efficient and clear communication paths, and processes for managing global trials.

In recent years, the challenges associated with language translation have decreased in OUS markets as global expertise in managing these activities has grown. In addition, there are numerous language service providers that are well-established and connected to the biotech and medical device arenas. However, it is critical to allow adequate time for planning translation and communication activities to ensure effective translation of clinical trial documents. Known areas of focus should include medical terminology and patient consent forms as sites must ensure patients are able to read and clearly understand the document.

Knowing the emerging market is critical to a well conducted and managed clinical trial to obtain the desired data and outcomes. In certain OUS regions, clinical research is still a relatively new field, and, some sites in these locations may have less experience in clinical trial logistics compared to more mature regions. It is advisable to utilize an experienced CRO in the geographical areas so these sites can be more closely managed. The CRO oversight can evaluate the capabilities of investigators and site monitoring plans. In addition, experienced clinical research associates (CRAs) are critical to ensure strong relationships with the less-mature sites, in order to provide effective communication, training and education.

Regulatory Considerations

It is crucial sponsors review the regulatory requirements for their desired commercialization locations prior to initiating their clinical trial. Many regulatory bodies do not accept a clinical trial that was conducted in a "for¬eign" country since it may not address the targeted country's requirements. Sponsors should also research the jurisdictions for which they want to receive regulatory approval. They must also determine where the acceptable geographic locations are to conduct a clinical trial for which the data will support a regulatory application. Not performing this step could have a significant impact on the clinical trial activities and product approval timelines.

What to know for different jurisdictions

When reviewing the regulatory requirements for different jurisdictions, make sure to evaluate the following:

  • What are the harmonized technical guidance documents that can be followed?
  • Are there any jurisdiction-specific requirements?
  • Are there any product-specific or disease-specific guidance documents? If so, are they also applicable to other countries?
  • Are there any programs that can facilitate product development and reduce time and cost to market?

Summary

Conducting clinical trials outside of the United States to support both US and OUS commercialization can provide a more efficient, cost effective and streamlined process. However, it is highly recommended to research and evaluate the OUS sites, the recognized competence of investigators in order to establish their processes and policies are acceptable to the desired regulatory bodies. Translational activities that determine key dialect and medical terminology compatibility is critical to ensuring efficient communications. Lastly, if working towards US FDA approval, utilize the FDA Guidance Document to determine that good clinical practices, data requirements, and appropriate ethics approvals are obtained when conducting trials outside of the United States.

 

*Mary McNamara-Cullinane is the Senior Director of Regulatory Affairs at Intrinsic Therapeutics

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