Before clinical trials began to cross international lines, recruiting patients was fairly simple. Recruiters had to research only one country's cultural and regulatory standards. But as trials go multinational and the various players in the global study community begin working together for the first time, sponsors discover new levels of complexity. Divergent regulations, cultures, and languages hamstring efforts to find a single approach to patient-outreach communications.
What will work in Italy, may not be culturally acceptable in Romania, legal in South Africa, or meet ethical standards in the United Kingdom. Companies recruiting patients need to localize outreach materials for each national population. To meet a country's ethical standards, recruiters have to understand the regulatory culture first, which means they have to learn more than the law. Global standards remain a tiny speck on the horizon, so companies are facing an uphill battle to determine, on a country-by-country basis, the appropriate way to approach potential patients.
Ethics committees and their review systems are central to the developing global regulatory climate. Like their US and Canadian counterparts, called Institutional Review Boards (IRBs), ethics committees are independent groups, comprised of both medical and non-medical personnel. They are charged with ensuring the protection, safety, and well-being of people participating in clinical trials. Committees review and approve the study protocol, investigators, facilities, and methods, and examine all materials to be used in obtaining and documenting informed consent of study participants. This includes patient-recruitment communications.
With different ethics committees often monitoring the same trial in several countries, compliance becomes a worldwide job. Typically, global study managers have little knowledge of regulatory or other recruitment conditions in countries outside their own, where trials take place. Recognizing that global patient-recruitment efforts hinge on accurate expectations about regulatory and ethical standards, BBK initiated an online survey of ethics committee members in more than 60 countries in Europe, Asia, and South America. Using local contacts and key opinion leaders to contact the most influential and experienced people available, BBK compiled a guide to precedents and preferences for patient-recruitment strategies around the world.