Increasingly, the global infrastructure supporting the development of new drugs, biologics and medical devices resides within clinical research organizations. In fact, while “big pharma” has been shedding research facilities and staff, members of the Association of Clinical Research Organizations (ACRO) have been on a solid growth path as we take on more responsibilities in all phases of the drug development enterprise.
With this perspective, we are paying close attention to the important work being undertaken by the Presidential Commission for the Study of Bioethical Issues. We are especially interested in the Commission’s work on ensuring that research is conducted in an ethical, safe manner across the globe. Currently, our members carry out research in more than 115 countries with two objectives in mind: protecting the safety of the research participants, and ensuring the quality and integrity of the data gathered in the course of the research.
Unfortunately, international research comes under almost constant attack, most often by those who make grand conclusions about ethics and quality based on a few anecdotes, or who are otherwise so prejudiced against the very concept of research outside the United States that they ignore all facts contrary to their opinions.
Here are some facts about global clinical research:
Population translates to speed. The U.S. population is approximately 311 million and the research participation rate is very low; only about 5 percent, for instance, among cancer patients. Meanwhile, the global population is 6.9 billion. So, to gather the necessary number of people to complete the volume of clinical trials needed to get a new drug approved, I believe it makes perfect sense to access a bigger population. This is the primary reason countries such as India and China are emerging as popular locations for clinical trials. Greater population = faster clinical trials = new treatments available sooner. It really is a simple equation. In fact, studies show that the research time needed for cancer clinical trials can be cut in half by conducting the trials globally versus solely in the U.S.
Quality is equal. We often encounter statements that “research quality in (fill in the country) is inferior to that in the United States.” Really? Is there any evidence to support these claims? Or just anecdotes? ACRO conducted a study of 25 multi-regional clinical trials involving more than 65,000 participants to address questions of quality. A third-party analysis concluded that there are no statistically significant differences in the quality of research data between or among countries and regions. Even using the U.S. as a benchmark, there are no differences compared to Russia, India, Argentina or any other country.
Regulation continues to evolve. Nothing is more important in clinical research than adhering to the highest standards of ethics and patient safety. On this point, there is
no disagreement. But whether research outside the U.S. adheres to lower ethical standards is, again, a claim that is rarely accompanied by supporting evidence. We are in the process of undertaking a study that will focus on issues of ethics, quality and patient safety at the investigator site level. With the substantial investment that CROs make in investigator training, a focus on compliance with Good Clinical Practice (GCP) guidelines and standardized project management and processes around the globe, we expect to see similar results from this study as we did with data quality. That is to say, no differences at all.
In the meantime, we believe it is highly important for countries to invest in their regulatory infrastructures to ensure the safe, ethical conduct of research within their borders. We also support increased appropriations for the U.S. Food and Drug Administration to carry out greater oversight internationally and to train and work with its fellow regulators around the world.
Ultimately, we believe that all research participants should be subject to the same level of protections – safety, ethics and regulatory – regardless of geography, funding source, or the setting of the research. We hope the Bioethics Commission comes to the same conclusion, finds that this is predominately the case currently and works for a remedy wherever there may be a gap.