Like most things, ethical considerations for clinical trials can produce both positive and negative results. The positives, of course, include protecting the rights, safety, and well-being of trial participants. And the negatives? Aside from the financial costs associated with review (which can be substantial), current systems to ‘promote’ ethical considerations are often overly complicated and slow. And at times, the system of ethical roadblocks, regulations, and bureaucracy for clinical trials procedures can be so restrictive that it actually prevents patients from receiving beneficial treatments within an reasonable period of time.
Ian Roberts of the London School of Hygiene and Tropical Medicine used the term “ethicide” to describe this phenomenon in a presentation at the Global Health 2011 conference this September. Roberts argued that while ethics are important to protect patient rights and ensure safety, sometimes ethical review boards can also prevent access to lifesaving treatments with long delays and requirements that don’t match the capacity of developing countries—some of the most endemic regions of the world. Ethical considerations should not only apply to a new treatment or procedure, but also to withholding the benefit of that procedure because of inaction, delay, or inaccessibility. At times, over-extended ethical considerations can morph to ethics violations in themselves, when safe, effective treatments are not accessible due to cumbersome and poorly coordinated regulatory procedures.
For example, Jeremy Farrar, director of Oxford University’s Clinical Research Unit in Vietnam, cites that it currently takes an average of 611 days from the inception of an idea to the recruitment of the first patients for a clinical trial. And as you can see from the chart below, some drugs can then spend an additional 10 years in the clinical trial process.
Figure from Safer, Faster, Cheaper: Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases
CGD’s Clinical Trials and Regulatory Pathways for Neglected Diseases Working Group, which launched its final report this week, assessed the ethical considerations associated with roadblocks and bottlenecks in clinical trial procedures and recommended ways to improve regulatory pathways to reduce costs, delays, and risks for trial subjects.
The working group report addresses the fact that institutional review boards and ethics committees often lack accountability for both the timeliness and quality of the review that they provide. When focusing on clinical trials for neglected tropical diseases—the regions with the highest burden often have the most inexperienced regulators and ethics committees. Further, the report cites that the practices of ethics committees are often opaque and not available to the public—a contributing factor to highly variable practices.
Improving ethics in clinical trials won’t be achieved by simply scaling-up ethical review, but by building better regulatory pathways that keep human research subjects safe while expediting the process to get beneficial, evidence-based treatments to the patients that need them. This solution would decrease the time spent in bureaucratic holding patterns, and enhance clinical trials ability to comply with normalized ethical standards—which are currently inconsistent across study locations.
Systems, like ethics committees, are created in order to solve a problem—in this case, the mistreatment of study subjects. But it’s possible that in designing and complying with systems, individuals and organizations lose sight of the original goal—improving health. Safe and timely clinical trials need not be a tradeoff.