Clinical Trial is a study or research into the effectiveness and safety profile of a new drug or natural treatment involving both healthy and patient volunteers.
In the US. Clinical trials are approved by the local institutional review board (IRB) that ensures study volunteers are fully informed of associated risks. The board also ensures participants have given their consent, and appropriate steps have been implemented to protect the participants from any harm during the study.1
The A B C D E of Clinical Trials
Before you even consider participating in a diabetes clinical trial, you need to know the basics of a clinical trial to make an informed decision whether you want to participate at all. Here we spell out the A B C D E of clinical trials and what it all means:
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Ask relevant questions before you join a trial
If you would like to take part in a clinical trial, you should always consult your doctor or a health care professional. Make sure you understand the side effects or drawbacks of the trial and consider asking the following questions:
- What is the purpose of the trial?
- How do I know if I am eligible to participate in the trial?
- How long is the trial?
- What are the benefits and risks of participating?
- Do I have to pay for the trial or do I get paid to partake in the study?
- What happens if I am harmed during the trial?
Benefits & Risks of Clinical Trials
The benefits of participation in clinical trials include access to research treatment at no cost before it becomes available to public; contributing to the medical research for the benefit of other patients.2
Potential risks to the volunteers may include possible unpleasant side effects, a control may be received or the treatment may be ineffective. Some trials may need multiple trips to the site, hospital stays or multiple complex dosage treatments. However, you can withdraw from a study at any time during the trial.2
The plan to design and conduct a clinical trial is called the Protocol. It is designed with precision and clarity to protect the health of participants and answer research questions. Protocol contains the following main information:
- Purpose of the research study
- Eligibility criteria such as demographics, type of diabetes, medication
- Information on treatment tests, products, medication or therapies
- Study duration and location
- Type of information to be collected
- Consent form and information sheet detailing benefits, risks and compensation for participation
Different types of Diabetes Clinical trials
TrialNet is an international platform for clinical trials in type 1 diabetes with multiple trials conducted at once under a collaborative umbrella. The platform consists of 18 Clinical Centers spread throughout the globe with participation from about 100 Affiliates as collaborating clinical sites.3
US based trials
Type 1 Diabetes – There are numerous ongoing trials with the most recent one by ViaCyte Inc. which is a private company in regenerative medicine.4 The company has recently launched first phase of clinical trial for a stem-cell derived product candidate (VC-01™) developed using two technologies: stem cell combined with an innovative delivery device called Encaptra® used to deliver a dose of cells in various body locations. 4
Type 2 Diabetes – This is an NIH-funded type 2 diabetes trial focusing on patients already on metformin medication. The trial is known as GRADE and involves assigning randomized participants to 1-4 commonly used glucose-lowering drugs plus metformin and followed for 7 years.5 The goal is to find the optimal combination of diabetes drugs for good glycemic control in long-term treatment of type 2 diabetes populations.5
UK based trials
Type 1 Diabetes During early stages of type 1 diabetes, up to 40% of pancreas cells make insulin which can still contribute to blood sugar control. For the first time in the world, a collaborative UK research team is using a peptide with ‘memory’ to test the safety of a human vaccine for type 1 diabetes.6
Type 2 Diabetes Pharmaleads a French biotech company has initiated one of the first trials ever to investigate the potential of a novel drug for chronic pain in diabetic neuropathy.7
Expectation of participants from clinical trials
Once enrolled in a clinical trial, there may be a physical examination and medical history review by the research team to establish a baseline and confirm original information received. The volunteer participant will be provided with a detailed description of the clinical protocol and a consent form prior to starting the trial. There will be health monitoring during the trial and following its completion.
Where can I find Diabetes Clinical Trials?
US Diabetes Clinical trials
- This site is a public database of all clinical trials maintained by collaborative efforts of the U.S. National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) https://clinicaltrials.gov/
- Centerwatch site provides a comprehensive list of all clinical trials for diabetes in the U.S
UK Diabetes Clinical trials
- Largest cure-focused research center for Diabetes in the world
- Leading UK initiative & independent health platform with large number of diabetes clinical trials listed from all over the world
- List of the most exciting and cutting edge research on Diabetes to participate
- Excellent site linked to most common trials for prevention, cure and treatment of type 1 diabetes
- Clinical trials on new medication for type 1 Diabetes
Common Clinical trial terminology
The source of these common clinical trial terminology is from www.Nih.gov & the FDA.gov websites.1,2 This information would help you while browsing diabetes clinical trials to understand what the clinical trials involve when they use these terminologies
Placebo is the control group where the drug or treatment is not received. In a clinical trial usually a new therapy or product is compared to an existing one to see if it is better or has fewer side effects.
Some research studies will involve participants to receive a placebo/control (an inactive product similar to the test one but with no treatment value).
The clinical trials provide you with an information sheet at the start which explains all about the trial including if a placebo is going to be used in the study.
Randomization the process when chance is used to assign two or more interventions (product or treatment) to volunteers. This is important to avoid bias and hence give strength to the results. The trial is stopped as soon as one treatment is found to be better than the other one.
Single or double-blind refers to masking the study in order to reduce the influence of the researchers or participants on the outcomes. When single-blind only the patients are unaware of the administered product. In double-blind also the researchers are unaware of which participants receive the product (s). That means researchers will have no influence on the results analysis.
These studies involve participants that are not aware of product or treatment they receive so as to remove bias.
Informed consent Is the process of providing volunteers with information on the key facts of the clinical trial of interest to help the volunteer decide whether they want to participate. It includes an information sheet on the protocol and consent form.
Phases of Clinical Trials – There are five phases of trials each with its own goal for a specific question to be answered:
- Phase 1 – Purpose of this phase is to assess the safety profile of the experimental drug or treatment initially on a small group (20-80)
- Phase 2 – Purpose of this phase is to determine the effectiveness and further assess the safety of the drug or treatment on a medium group (100-300)
- Phase 3 – The goal of this phase is to compare effectiveness to equivalent treatment or drugs in a much larger group (1000-3000). Also the side effects are monitored and different dosage of the drug alone or in combination with other medication is used.
- Phase 4 – Once the drug is approved by the FDA and becomes available to the general public, the goal is tracking the safety profile and collecting more information about its optimal application.
Tips & Guide to participation in diabetes clinical trial
- As there are hundreds of diabetes clinical trials available, first discuss with your doctor to help you select a relevant trial to participate
- Familiarize yourself with the clinical trial terminologies to ensure you understand what the trial involves
- Make sure you understand the protocol for the trial and that you are eligible to participate
- Consider cost issues such as travel or childcare while partaking in the diabetes clinical trial
- If eligible for participation, take a friend or family member along for extra support
- Be proactive and plan any questions or concerns you may have
- Read the informed consent and information sheet detailing the study carefully before signing and remember you can withdraw at any time
I hope this article was helpful.
- FDA website describe clinical trials in detail as well as the stages of new drug development
- National Institute of health website provides comprehensive educational material on clinical trials
- International site dedicated to Type 1 Diabetes prevention and cure
- Stem cell research into type 1 diabetes by ViaCyte Company in U.S
- Grade site is about trials on different combination of medication for type 2 diabetes
- Vaccine Trials for Type 1 Diabetes
- Diabetes Clinical trial on pain control in France/UK