It only seems logical that clinical trials should include representative samples of the population most likely to benefit from the drug, assuming it is approved. Yet, today there is limited diversity in the people participating in clinical research.
The topic of inclusion and diversity often starts with looking at gender or ethnicity. However, there are more factors to consider, such as socioeconomic barriers and poorer rural locations. Consider language or literacy challenges for less-educated populations. And there are financial considerations as many underprivileged potential patients can’t pay for treatment and may not be covered by adequate (or any) medical insurance.
Clinical trials provide advanced treatments for complex illnesses, such as cancer, that is beyond what a physician could offer with standard care. As a result, there is an ethical obligation to expand access to more people. A more diverse patient population will also help to evaluate efficacy and safety risks by surfacing harmful side effects that may impact one ethnic group compared with another.
Everyone – sponsors, CROs, physicians, research sites, and patients themselves – needs to be part of this conversation if we are to move towards more inclusive, diverse clinical trials.
If we start with making clinical trials simpler and more accessible for physicians, we can reach more patients. Estimates suggest that a small number of physicians participate in clinical research. Some legitimately don’t want to participate, but for others there is a perceived lack of opportunity. And yet, tapping into the local community by local physicians is a way to reach and build trust with underrepresented and under researched patient populations.
But it is not easy for investigators and research staff to run clinical trials today. Protocols are increasingly complex. For example, there are nearly double the number of endpoints and almost triple the amount of overall data in clinical trials compared with just 10 years ago, according to the Tufts Center for the Study of Drug Development (CSDD).
If we look at how clinical trials are conducted today, research staff still rely on antiquated ways to get protocol information. Desktop computers, paper copies, and study monitors are the most frequent sources of information, according to new research from Tufts CSDD. It is a paradox that research of cutting-edge medicine is guided by such unsophisticated information sources.
Lack of convenient access to study information means time delays in getting answers. And it also introduces potential errors, particularly with paper, if sites are following the wrong version of the protocol. For physicians at medical facilities tending to underprivileged populations, time and resources are precious. Conducting clinical trials in compliance with the protocol needs to be simple.
At Teckro, we were founded on a mission to make clinical trials simpler, more accessible and transparent. We connect investigators and research staff with critical study information and essential guidance when and where they need it. The result is that sites enroll faster, have fewer errors, and better adhere to the protocol.
Think of Teckro as an investigator’s very own personal clinical trial assistant that is always available from any digital device.
Answers are returned in seconds by analyzing all available study information, which could sit in more than just the protocol (e.g. investigator brochure, lab manuals, CTCAE, etc.). And results are only considered from the current, approved protocol for that site. This means investigators and research staff can have confidence in the decisions they are making about enrollment, procedures or how to manage a particular adverse event.
Teckro also gives monitors and sponsors insights with a wealth of information on who is searching and for what kind of answers. Monitors can then proactively focus on sites that need more help, while sponsors can identify the need for clarifications or early indications of potential safety issues.
In the case where additional guidance can help sites, Teckro connects sponsors, monitors and research staff with an efficient, compliant communication channel. Sponsors and monitors can send targeted messages with reminders, tips or study updates to help investigators and research staff. In turn, research staff can initiate messages to medical experts to get further clarification or confirmation on a given course of action. With Teckro, monitors and sponsors can also stay close to newer sites by sending quick surveys to get their feedback and identify any blocking issues.