Regulatory Timelines Stall Clinical Trials
by Christina Blanchard-Horan, PhD
When considering the challenges that Clinical Trials Scientists have one that seriously impacts their timeline is obtaining in-country approvals to conduct the trials to improve healthcare. Some research suggests that regulatory approvals are tied to policy and other factors (Blanchard-Horan, et al., 2012). “Missing from the discourse about timelines to regulatory approval is the cultural, political, and historical elements that influence decision-making.” Blanchard-Horan also suggests that IRBs struggle with few resources and historical factors brought on by [i]parachute researchers that may still influence decision making. This could be leading IRBs to carefully scrutinize and question the purpose of research. This is research sponsored by foreign entities. This especially true when local investigators are not a part of the research team. However, further research is required to determine any connection.
Delaying Clinical Trials
Delays in starting clinical trials add to the cost. It also impact clinical decision making in all settings including RLS (Institute of Medicine (US), 2010). Delays in any country interested in participating in a multi-center study means fewer people are included in the results. It also may lead to less data collected about that particular population. And in some cases, studies are completed before a site has all regulatory approvals, excluding their population completely from important research findings.
Regulatory timelines also impact decisions about where to conduct research. For example, South Africa has been a prime destination for AIDS research. However, due to excessive delays in the regulatory process at its Medicines Control Council, at least one pharmaceutical company chose to leave the country. (Kahn, 2012) When companies choose not to conduct studies in those countries with lengthy regulatory timelines, people of those countries lose.
The timeline of regulatory approval is impacted by numerous factors. One of the most important is the type of study. Those involving pregnant women or children require more careful review, as these are vulnerable populations. Frequently, Institutional Review Boards (IRBs) at institutions in a number of countries in Africa do not have the adequate expertise on the board and farm out the review of some studies. Needless to say, this takes additional time, often months, sometimes years.
Sponsoring agencies walk a delicate line between their desire to assist other governments’ agencies to become more proficient and overstepping a perceived political boundary. Development agencies, such as USAID have been addressing governance for many years. Clinical trials sponsors could learn much from their experience by partnering with agencies providing development aid to resolve these challenges. After all, it is a development problem. Clinical trials are most often conducted for and by the vulnerable populations, e.g. people with HIV, pregnant women, children of HIV+ parents. While they consider behavior change and help to determine appropriate available drugs given the context, the international work for some agencies is relatively new.
[i] Parachute researchers are those who drop in, conduct a study and leave without giving back to those communities.