How to be sure clinical trials deliver results, safely
Scientific research is one of the broadest areas of creativity and intellectual development, given its essential goal in discovering medical or scientific solutions to issues that we may all face in our daily lives.
Valuable research is characterized by its scientific and methodological nature. It may be conducted on living organisms, and may be experimental — with medical intervention such as clinical trials, for example — or theoretical, aimed at deducing new information to serve a particular purpose. It may also be non-medical, targeting other sectors, and even literary and social topics. In all cases, however, there is a relationship between research and ethics, and the bodies that govern them, to ensure fair outcomes.
Clinical trials are among the most important types of research, aimed primarily at obtaining more knowledge about diseases, developing diagnostic methods and introducing new therapies or medical devices to raise the level of health care. Such trials should be carried out by competent and authorized specialists, who are required to take all necessary measures to protect the subject of research. The research process itself is codified, so all the required legal and ethical steps must be taken, and regulatory approval obtained.
Clinical trials should be conducted in accordance with the ethical principles prescribed by the 1964 Declaration of Helsinki and its later revisions, developed by the World Medical Association. They must also be consistent with Good Clinical Practice, an international ethical and scientific quality standard that governs the performance and reporting methods of clinical trials.
In addition, the Saudi National Committee of Bio and Medical Ethics aims to develop and monitor compliance with biomedical research ethics and practices, and the Saudi Food and Drugs Authority sets regulations and guidelines for research in the food and drugs sectors.
The bioethics committee is also responsible for inspecting clinical trial sites to ensure that researchers meet all the requirements for good clinical practice, including consent, confidentiality and duty of care. There are also checks to ensure adequate and proper medical care in case of any adverse event.
Of course, before a trial even begins, foreseeable risks should be weighed against the anticipated benefit for the individual trial subject, and society as a whole. The trial will proceed only if the anticipated benefits justify the risks.
All scientific research carries with it the risk that valuable information may be stolen or used illegally, intentionally or otherwise, which can disrupt the research process. Vigilance is therefore one of the most important pillars of research.
Applying a robust ethical and regulatory foundation to scientific research will ensure fruitful results, while guaranteeing the integrity and accuracy of the research process, ensuring the rights of the individuals involved, and protecting intellectual property.
Dimah Talal Alsharif is a Saudi legal consultant, head of the health law department at the law firm of Majed Garoub and a member of the International Association of Lawyers. Twitter: @dimah_alsharif