When developing treatments for a relatively common illness or disease, patient recruitment is relatively straightforward. Screening and data collection can generally be done in a centralized location in a highly controlled environment. Now, imagine the concentration of people with the disease is not high enough in your local area, or even your country for that matter. What do you do now?
Let’s assume you find a sample size of patients spread throughout the world that is large enough to accommodate your clinical trial. Since they are afflicted by the rare disease you are studying, chances are they aren’t well enough to travel, let alone relocate to your research site. You must then find a way to take the research to them. Simple enough, right?
Regulatory Framework Varies
When you are dealing with patients in a variety of countries, you are also dealing with the governments of those countries. Since regulatory frameworks and ethical requirements vary from country to country, it is then the researcher’s responsibility to adhere to those standards in the countries in which patients are located. Even regions within a country often have different regulations governing medical trials, creating a mountain to overcome during the planning phases of clinical trials.
The same argument can be made about import/export requirements and travel restrictions. Many countries have extremely complicated regulations regarding importing and exporting medications under clinical trial. Some regions have travel restrictions limiting the number of days people are allowed to spend in their country, the types of visas that can be awarded, and the regulatory agencies that are allowed to supervise the trial. For example, Iran does not allow FDA inspectors to travel to investigative sites. If the drug is being produced in the U.S., this can become a regulatory sticking point for trials conducted in Iran.
The State of the Country
The stability of a country’s government can be a limiting factor when determining if a clinical trial can move forward in that country. Travel restrictions, strained international relations, even differing standards of care can greatly impact the quality of research that is derived from certain countries. If you have to leave the country for a week every three months to maintain your visa, those issues must be accounted for in the research phase of the trial. If relations are strained between the country of origin and the target nation, finding another patient population may be to the benefit of everyone involved.
Patient Reimbursement May Be a No-No
Countries may have different regulations, processes and even customs regarding patient reimbursement. It may make financial and cultural sense to cover travel expenses in one country because the regulations and customs allow for it, but not another. Small gifts may be substituted for financial reimbursement, but customs and processes must still be accounted for and honored.
When conducting rare disease research, gathering an adequate sample size is difficult. That is where the research before the research becomes critical as the regulatory, political and customary environment is taken into account.
Learn more on rare disease patient recruitment by having a look at our Rare Disease Research – Conducting Clinical Trials Where The Patients Are webinar.