Clinical trials are currently being held on every continent except Antarctica. However, emerging countries have long been rising to the top level of consideration for conducting clinical trials.
Most sources identify emerging countries based on their economic development and reform programs: They “have begun to open up their markets and ’emerge’ onto the global scene. Emerging market economies are considered to be fast-growing economies.” Emerging countries include Brazil, Chile, China, Egypt, Mexico, Nigeria, Pakistan, Eastern Europe and South Africa, among many others in South America, Africa, Asia, the Middle East and the Far East.
Criteria for Selecting a Clinical Trial Site
In choosing where to conduct a clinical trial, contract research organizations (CROs) look especially at these criteria:
- The ease of recruiting patients
- The ease of recruiting qualified medical staff
- Applicability of data (for example, ethnic heritage might be a consideration)
- Regulatory requirements (for example, a country may refuse to import a drug essential to the trial)
- The efficiency of the approval process
- The resources already available (for example, a regional hospital providing specialized equipment and a pool of physicians/patients)
- The market potential of the country (that is, whether individuals will be able to access the medication or treatment after it is approved).
- The standards of care are acceptable for the study in regards to integrity and consistency of data.
Prior regional experience by the CRO and/or research team is essential in finding a site because a network of former relationships can help ease every step of the clinical trial process, including recruitment, validation of physician credentials and regulatory approvals.
Advantages of Emerging Countries for Clinical Trials
As sites for clinical trials, emerging countries have several advantages over developed countries.
Often, their medical staff is more motivated because they are eager to increase their credentials by participating in the trial and they have fewer conflicting obligations to hospitals, universities or other research organizations. Patients may also be more motivated by having access to regular medical care that would otherwise be out of their reach.
Because most emerging countries have become more aware of standards for good clinical practice and other regulatory and research standards, clinical trials in those countries are regulatory compliant to the standards of developed countries—helping to ensure that the results are acceptable worldwide. Yet, the costs of performing the clinical trial are generally lower in emerging countries, making the trial more cost-effective.
Sometimes an emerging country will develop a specialty in, for example, data management or bioequivalence studies. Sometimes an increased efficiency in review and approval processes or the addition of special requirements, such as post-marketing safety studies, will change the suitability of a site, making it more or less attractive.
For example, in 2012, researchers were aware that China, among other countries, was developing regulatory structures; now the China Food and Drug Administration (CFDA) oversees all clinical trials. In 2012, Costa Rica suspended all new clinical trials until they revise their clinical trial laws. Currently, there are several clinical trials underway there.
CROs monitor these and other changes over time to better serve sponsors and research organizations in helping them choose the best site for a clinical trial.
Where Confidence Pharmaceutical Research Fits In
The clinical research associates at Confidence Pharmaceutical Research have developed relationships with physicians, regulatory agencies and vendors in emerging countries around the world. We understand the pros and cons of each potential site and how to work with governments, medical professionals and patients to conclude a successful clinical trial on time and on budget. Please contact us today.