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International Clinical Trials

Odd One Out

Over recent years, permissive science, innovative trial methodology, evolving regulatory sentiments and increasingly sophisticated commercialisation have all contributed to drug development. However, some challenges still remain. Poor understanding regarding the natural history of the proposed indication due to few observational trials studying disease progression, recruiting and retaining patients and investigators as well as regulatory uncertainties can all prove difficult, to detail just a few.

Facilitating Enrolment

A smaller selection of patients and, occasionally, a decreased likelihood of finding and engaging patient advocacy groups, means that identifying and locating participants can be extremely perplexing for orphan drug researchers.

The benefits of working with patient advocy groups are invaluable to researchers when attempting to seek out participants. These groups usually involve patient caregivers or relatives, as well as doctors and key opinion leaders (KOLs) in the specific indication. It is crucial for CROs, sponsors and investigators to reach out and communicate with these groups – especially during the initial stages of a protocol design – because having their cooperation at this point can be crucial to the success of a trial. By taking the time to meet and speak with members of any relevant groups, researchers can gain valuable insight into a particular condition – including what life is like for potential participants, as well as what is important to the caregivers and others in the patient’s network.

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Jeffrey Zucker is Senior Vice President of Global Clinical Operations at Worldwide Clinical Trials. His current responsibilities include growing and continually improving the company’s global and site feasibility capabilities. Jeffrey also oversees the evolving Patient Recruitment and Site Relations departments and has been in the clinical research industry for 20 years.
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Zeffrey Zucker
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