Efficiency of clinical trials is probably the industry’s and government’s number one goal. It is so important that it is being discussed all over again by all stakeholders within the clinical research industry: industry, academia, government, nonprofit organizations, and patient advocates, clinical investigators, patients, payers, physicians, and regulators. Efficacy has been challenged though by many factors:
- access to well-characterized and often treatment naïve
- willing participants
- availability of qualified local investigators who are eager to conduct trials;
- the enhanced capacity of international sites
- the lower cost of conducting trials in developing countries.
So all these factors bring us to the fact that the following question:
Can globalization increase efficiency of clinical trials?
should be actually replaced with:
Can efficiency be even possible without globalization?
Efficiency of clinical trials is a very relative term that can be hardly defined, but the main goal (the one we all should focus on) is nothing else but ensuring public safety and health. From that perspective we need to consider following consequences of clinical research:
- all countries, which develop clinical research structures, have better healthcare system;
- if we have more successful clinical trials we potentially have more chances to increase quality of life;
With that said globalization made it possible not only to have more efficient clinical trials, but also the optimize the outcome form clinical research to places of the world where healthcare is poorly developed, places like Africa. And we can use a simple example from the technology:
Bank services in Africa were so bad for a long time, until mobile payments started gaining their market share and now African countries are using mobile payments more than anywhere in the world, though they never had well structured banking system.
International clinical trials made it possible to reduce the time for a drug or medical device to come to the market, because now sponsors and all other parties can relay on a lot more potential patients willing to participate in the studies and contribute to the progress of pharma and medicine. We need to also remember that this brings also diversity of the subjects testing the new treatments, which make the results of the clinical trials a lot more real and clear.
Regulatory control is another factor that proves that globalization increases clinical research efficiency. Having more locations involved this brings more and new regulatory bodies, local authorities together. Though, this might be challenging for documentation and data submission and control, it is also helpful because there are many countries where they are just starting building their institutions according to the international standards. They will be able in this sense to build more efficient procedures, which will save time and money.
There are certainly a lot to be added to how globalization affects the efficiency of clinical trials, but what is also important to recognize the challenges of international clinical trials, something we will cover in our next articles. If you want to learn more about regulations and the future of clinical research follow our blog: https://crotraining.co.uk/blog/
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