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?

Low participation

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.

Not enough funding

Insufficient funding is another obstacle that slows clinical research.   NIH and industry are the  primary sources of funding as well as non-profit foundations, and universities. NIH funding is down “largely [due] to declines in its budget in real terms…From 2005 to 2015 the number of NIH-funded clinical trials registered annually fell from 1,580 to 930, a drop of more than 40 percent.”[6] Industry now funds six times more clinical trials than NIH.[7] This is important because industry has a specific objective which is to commercialize their product. NIH and foundation funded research is fundamentally different. Their objective is to support public health. 

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.[8] [9] There are over a hundred actively recruiting studies (not including the multiple locations of some studies) around the US just for Type 1 diabetes.  Zoom in on this map to find a trial near you.

The map information is from ClinicalTrials.gov: blue pins are drug studies, red pins are device studies, green pins are biological studies (which can mean cell based therapy including a biotech drug), light blue pins are behavioral studies and yellow pins are other. These categories come from ClinicalTrials.gov and don’t always make complete sense. We would love to hear from you about what information would be helpful.

ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine.
IMPORTANT: Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits.

TERMS AND CONDITIONS

Donate

And if volunteering for clinical research isn’t your style or simply isn’t possible, you can always find clinical research that you are passionate about and donate to fund that specific research.

Visit Diabetes Research Connection to review the projects currently approved and seeking funding. Be the difference and support a research project today!

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] https://www.jhsph.edu/news/news-releases/2018/nih-funding-fewer-cinical-trials-study-suggests.html

[7] http://www.baltimoresun.com/health/bs-hs-trial-funding-20151214-story.html

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

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


Learn about the different stages of clinical trials.