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The importance of human subject protection, clear communication, and community spirit are among the issues emerging from the tragedy.
It is a little over a year since the Hurricane Katrina disaster. We have been reminded of the horror of those days through vivid pictures documented in the press and on TV and the Internet. The following quote by Cora Christian, MD, reminds us of the work that is still to be done in the research community: "Drug development and hurricanes have much in common...what takes years to build can be destroyed in only a moment" (DIA Annual meeting, June 2005 ). What we must ask ourselves is: What have we learned over the last year from this disaster?
While Katrina is uppermost in our minds, it is important to recognize the increasing risk of any disaster to society. Threats of terrorism, pandemic flu, tsunamis, and earthquakes are indeed real and potentially far reaching, yet our industry has done little to prepare. If we are to improve and learn from disasters, we must not wait to be told the right thing to do but rather act prospectively and establish practices that do the right thing.
Hurricane Katrina is one vivid example of how unprepared our clinical research community is in the wake of such a disaster. There are three lessons that we can learn from Katrina. Although the following examples may be minor compared to the lives, homes, and businesses that were lost, displaced, and destroyed, we have to start somewhere to right the wrongs of practice without spirit. For if we do not make any attempt at change, then we are setting ourselves up for greater failure in the next disaster.
Human subject protection reaches far beyond informed consent. In a time of disaster, policies such as HIPAA that were intended to protect us indeed hindered us. After Katrina, many subjects in ongoing clinical trials were unable to communicate with their Investigators. Even if communication was established, Investigators had no access to treatment assignments, as most records (even electronic) were de-identified for confidentiality purposes.
Due to lack of planning, most sponsors and study sites had no access to subject identification since all records were "securely" maintained within institutional walls. Therefore, we must plan. We must write policies that allow flexibility as we refocus on the true meaning of subject protection.
Small but positive improvements to provide this flexibility are underway in Louisiana. One large institution has designed a software system that allows remote but secure access to personal identification parameters to all persons enrolled in clinical trials. The system is only accessible to three individuals identified in the institution's disaster preparation plan.
An equally thought-provoking option has been the use of universal subject identification numbers, similar in practice to the social security numbering system in the United States. Aside from rapid subject identification in times of disaster, this identifier could help mitigate another form of risk: an individual participating in multiple studies simultaneously.
Communication is the key to survival. This point easily parallels our earlier observation of subject protection. The communication plans of sponsors, sites, IRBs, and institutions were woefully underdeveloped for a disaster. IRBs and clinical study sites must become more diligent in their planning, seeking out nonlocal contact information for study participants. A few IRBs now require subjects to be given contact information in the form of an identification card.
Sponsors could better prepare by performing risk assessments of study sites based on geographical location and consider radio communication processes for subjects postdisaster. An additional proposal includes a universal toll-free phone number as a regulatory requirement for investigational product labels. Subjects are likely to evacuate with all types of medication, including investigational products. As a result, a phone number affords them a means of communication regardless of their ultimate location.
Of course, significant regulatory action would be required to enforce this type of change and other planning would be required to ensure success. Even so, a small, relatively innocuous act by sponsors could have far-reaching effects toward improving human subject protection.
Humans are socialized beings. Rarely do we have subject populations with a sample size of "1"—think about your last clinical trial. Taking this idea further, any successful industry truly embraces the "entire village" concept.
Members of our village include our study participants, our drug development teams, our clinical study sites, our ethics committees, and our regulators. For our industry to succeed, the village must succeed.
We learned that surviving a disaster took a village approach. We expect to leverage this sense of community spirit in many ways. We are recycling used study binders for local schools. Academic facilities and institutions are partnering in unprecedented ways. Study sites have partnered with one another as back-up locations in times of need. We have reorganized local clinical research chapters and planned social events. And, ultimately, we find ourselves discussing and highlighting the true contributions we make to the betterment of society.
I wonder how drug development might improve exponentially if we only apply these three small lessons on a more global scale. It is true that small things can become larger. Let's remember, that hurricane began as only one wave.
Alicia Pouncey, MEd, is managing director with Aureus Research Consultants, LLC, 2237 North Hullen, Suite 301, Metairie, LA 70001, (504) 833-1528, fax (504) 833-1567, Alicia@AureusResearch.com, www.aureusresearch.com