SOURCE: Xtalks

Xtalks Webinars

November 17, 2015 07:00 ET

Rare Disease Research: Conducting Clinical Trials Where the Patients Are

TORONTO, ON--(Marketwired - November 17, 2015) - On Tuesday, December 1, 2015, Premier Research will feature a live webinar on rare disease research. In many rare and ultra-rare disease studies, sponsors do not have the luxury of choosing the countries where the study is conducted. They must use the sites where those patients are being treated, regardless of location. Additional protocol criteria, such as treatment-naïve patients, or general prevalence of a disease by region may limit site selection even further, requiring the sponsor to open sites in countries that normally would not be considered for clinical trials.

Opening sites in countries where clinical trials are uncommon requires detailed knowledge of the host countries and the complex regulations they may impose, along with thorough site training in protocol and good clinical practices. In addition, monitoring and trial oversight must focus on getting every patient through the study with minimal protocol deviations and other issues to ensure data integrity.

It's highly preferable to identify patients before opening a site and to ensure the patients will qualify for the study. This can avoid wasting effort and expenses in opening a site where no patients will be enrolled. Also, extra measures may be required to ensure that patients are able to participate in the trial -- for example, arranging for extended patient travel, supporting the patient's family, and arranging home visits by a study nurse.

Other important site considerations include:

  • Countries with complicated import/export requirements, especially regarding shipment of samples
  • Travel restrictions -- for example, FDA inspectors cannot travel to sites in Iran. Therefore, if you use an Iranian site, the quality of data and documentation must be top notch or the FDA might not accept it
  • Countries have widely different regulations and processes for site and patient reimbursement that need to comply with GCP and the sponsor's local regulations
  • Investigator meetings must be conducted in a country where the sponsor and all participating sites can travel freely

Join featured speakers Alison Sampson, Senior Project Director at Premier Research, and Hanna Wide, Project Manager at Premier Research, for an informative one-hour session that will include a Q&A with the audience.

For more information about this event (hosted by Xtalks) or to register visit: Rare Disease Research: Conducting Clinical Trials Where the Patients Are

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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