Putting the “Community” in Community Service A call to action Hurricane Katrina damaged or destroyed dozens of research sites along the Gulf Coast and dislocated hundreds of employees and thousands of study participants. Pharmaceutical and biotechnology companies reacted quickly to the hurricane, committing millions in money and medical supplies, as well as thousands of hours of staff time within a few days. Individuals in the clinical-research industry have made many personal contributions of time and money. But few people in clinical research have yet perceived that Hurricane Katrina is also a huge opportunity to build the clinical-research community. Hurricane Katrina gives the clinical-research industry the opportunity to move beyond a community of conference attendees to become an extended “band of brothers.” Writing a check to a public-relief fund is admirable, but it is also possible to leverage — at no extra cost — that same contribution into countless personal relationships that tie the community together. The clinical-research community includes pharmaceutical, biotech, and medical-device companies, academic and private clinical-research sites, contract research organizations (CROs) and other suppliers, government funding and regulatory agencies, research subjects, and more than 130 industry associations and 110 publications that serve the community directly or indirectly. Unlike most other industries, however, many participants play dual roles. Most research investigators are practicing physicians, so they have a supplier/customer relationship with pharmaceutical companies and study participants. Study participants are also patients, so they also have a dual relationship with research investigators and pharmaceutical companies. More than 2 million U.S. residents will participate in industry-sponsored clinical research studies this year. Many participate entirely out of personal interest, but many others participate, at least in part, to help their community. Regardless of their reasons, their cooperation is essential for progress in medical science, and the survival of the clinical-research industry. Study participants are as much members of the clinical-research community as the researchers: Researchers give time; study participants also give time, and blood and sometimes sweat and tears. Some of the Hurricane Katrina evacuees were participating in active clinical studies. Does the clinical-research community have an obligation to help these members of our community? Clearly it does; that’s what it means to be members of a community. Here is a concrete example of what the clinical-research industry could do: Most large pharmaceutical companies have patient-assistance programs that provide free or low-cost medicines to people who otherwise cannot afford them. If the pharmaceutical companies were to designate even 10% of these medicines for Hurricane Katrina victims within the community, it would give the rest of the community an important and feel-good reason to track down missing study participants, many of whom are in ill-health and just lost their health insurance. Research sites know where these people are, but are legally prohibited from disclosing their names to the pharmaceutical companies. By working together, the community can get medicines to members who need them. A new group, the Clinical Research Relief Organization (CRRO), is working to coordinate the clinical-research community’s relief efforts. Hurricane Katrina was especially horrific, but FEMA declares about 50 natural disasters a year. CRRO is likely to play an important role in the clinical-research community for years to come. To become involved, CRRO’s Website is: firstclinical.com/CRRO/CRRO.html. Norman M. Goldfarb Chairman Clinical Research Relief Organization Managing Partner First Clinical Research October 2005 PharmaVOICE

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