All About Clinical Trials

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What is clinical research and why is it important?

According to the NIH, the purpose of clinical research is to “advance medical knowledge by studying people.”[1] This means that clinical researchers are trying to answer important questions that will lead to better ways to prevent, treat, and cure disease. This is different from medical care, which is where your doctor is developing a care plan specific for you (based on the results of previous clinical research!).

Clinical research is conducted with carefully designed and regulated clinical trials where “patients volunteer to participate in studies to test the efficacy and safety of new medical interventions.”[2]  These trials are “designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.”[3]

Ultimately the goal is to drive better health outcomes. “By taking part in clinical trials, participants not only play a more active role in their own health care, but they also can access experimental treatments and help others by contributing to medical research.”[1]

Who should consider clinical trials and why?

Choosing to participate in a clinical trial is a very personal decision. Early access to promising new treatment can be one benefit. Others have found that by participating in a clinical trial, they learned more about their health or their medical condition. And some are motivated because “they want to contribute to the advancement of medical knowledge.”[4] Of course, clinical research means there are unknowns and the amount of risk varies considerably by study. It is vital that you ask questions and are fully informed before consenting to participate in a study.

Are clinical trials safe?

Because this is such an important question, we have included the official FDA statement:  “FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.”

“The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.”[4]

A related issue is confidentiality. Clinical trial participation is kept confidential. “Personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers.” [4]

What are the obstacles to clinical research?

One of the biggest barriers to clinical research is low participation. “There are many explanations for low clinical trial participation rates: practical barriers like inconvenience and cost, but also psychosocial obstacles such as knowledge gaps and negative attitudes about research studies.”[5]  An encouraging study showed that clinical trial participation increased from 5% to 21% by simply educating patients about clinical trials through videos or reading material.[5]  Perhaps a path to greater participation in diabetes trials is through information that we can offer here at Beyond Type 1.

How can I contribute to clinical research?

Volunteer

The best way for you to get involved with clinical research is to volunteer as a research participant. 19% of registered trials never get off the ground because they don’t get enough volunteers, and low recruitment has been identified as one of the top three main pain points in clinical trials.[6] [7] There are over a hundred actively recruiting studies (not including the multiple locations of some studies) around the US just for Type 1 diabetes.  Use the tool below to find a clinical trial near you.

Donate

And if volunteering for clinical research isn’t your style or simply isn’t possible, you can always donate to JDRF, the world’s biggest nonprofit funder of Type 1 diabetes research.

References

[1] https://www.nichd.nih.gov/health/clinical-research

[2] https://www.ncbi.nlm.nih.gov/books/NBK9571/

[3] https://www.fda.gov/forpatients/clinicaltrials/default.htm

[4] https://www.fda.gov/forpatients/clinicaltrials/clinicalvsmedical/default.htm

[5] http://news.feinberg.northwestern.edu/2016/02/overcoming-barriers-to-clinical-trial-participation/

[6] http://www.appliedclinicaltrialsonline.com/barriers-clinical-trial-recruitment-and-possible-solutions-stakeholder-survey

[7] https://info.forteresearch.com/


Learn about the different stages of clinical trials.