Respectful Research
June 2007
Judith Beach, senior associate general counsel for regulatory and government affairs, and chief privacy officer at Quintiles Transnational, discusses the importance of applying relevant ethical standards when conducting global research.
As clinical research becomes more global, delivering efficacious drugs as quickly as possible must be balanced with maximizing patient protection and maintaining appropriate ethical standards. To achieve this balance, trial sponsors and contract research organizations (CROs) must be respectful of different cultures and knowledgeable of the laws and regulations in each country where they conduct research.
Applying comparable ethical and operational standards across the board while making appropriate accommodations for cultural differences is of utmost importance when conducting clinical trials globally. For example, the process of obtaining a patient’s adequate informed consent can vary significantly from location to location due to cultural differences. This is particularly the case when conducting trials in rural areas of emerging countries. In some areas, the local leaders or elders consent on behalf of community members. In comparison, generally recognized ethical standards of the West require individual-based consent. So, we must adapt and make adjustments for clinical trials that have unique cultural circumstances, but at the same time helps to ensure individual protection.
The underlying responsibility for sponsors and contract research organizations remains the same—to make certain that the patient adequately understands the nature of his or her involvement in the study. At one of our Phase I units, for instance, we give potential trial participants a test on the provisions of the study-specific informed consent, and if they are not able to articulate that they understand the study, they must retake the test. If after further reviewing the consent, they are still unable to indicate their understanding, they can’t participate in the study. This is certainly not appropriate for every location, but it’s an innovative approach to ensuring that the research participants are adequately consented, and proves that the trial is being conducted responsibly.
We also work to ensure that the investigators understand and appreciate the importance of keeping the integrity of the trial. We make every effort to train investigators fully on the study protocol, so that they understand not only exactly how to conduct the clinical trial, but also the potential risks and benefits to their patients. The more time spent on site initiation and investigator training, the more dedicated and interested the field staff will be, which ultimately leads to a better trial, with better protection and care for the patients.
Particularly in emerging regions, investigators must understand applicable clinical trial regulations and rely on the trial sponsor for guidance and feedback. As the primary touch point between sponsor and investigator during the course of a trial, properly trained site monitors can make a big difference in how the study is carried out in the field, thus ensuring compliance. Primarily, monitors should ensure that all patients are treated with the same standards of excellence, from site to site, and from country to country.
Field work with the investigative staff at a trial site is only part of ensuring responsible conduct of clinical trials. Due to the nature of medical products, every company involved in biopharmaceutical research is held to much higher ethical standards than companies in most other industries—and rightfully so. The slightest perception by the general public that something is amiss can have a long-lasting detrimental effect on the entire industry. Therefore, careful consideration of ethical issues should be carried out at the corporate level.
Almost all biopharmaceutical companies have ethics policies, an ethics office and sometimes even an ethics helpline that people may call with concerns. At Quintiles, we have all these, and in addition we have chartered our Council on Research Ethics (CORE), which essentially functions as an internal ethics board. The CORE is composed of Quintiles representatives from around the world, each of whom must undergo in-depth training in research ethics. The CORE also includes an independent member, who provides guidance on universal ethical principles to the group. The CORE meets regularly to discuss ethical concerns involving research issues that have developed. If something critical occurs, a designated smaller group of the CORE members will convene on an expedited basis to make timely recommendations.
The global representation and informal nature of the meetings is what makes the CORE effective, interesting and, for me, very rewarding. We get quite a cross-section of input on each issue, and the different cultural perspectives ensure that our company as a whole is thinking and behaving responsibly. The critical step, of course, is translating the CORE’s decisions into the field. Since the CORE consists of key leaders from different functions of the company, each member is able to incorporate new directives into policies within their area. Furthermore, due to the cultural mix, the CORE keeps our research standards consistent worldwide. And that is what we, as an industry, should always strive for: conducting clinical research in a consistent and responsible, ethical manner.
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