About Spoke Research

Spoke Research Inc is a clinical research company dedicated to the clinical research of Diseases of the Immune System.

Spoke Research performs various Clinical Trials with the hope of finding a better treatment for Crohn’s Disease and Ulcerative Colitis.

Our investigations vary from current to innovative treatments and how it affects human health.

Spoke Research was created in 2017 after we were approached to partake in clinical research trials in Inflammatory Bowel Disease.

Since this offered our patients access to novel treatments, we decided to embark on this journey with our patients and Sponsors.

Currently, we are specializing in “Phase 3” clinical trials for Inflammatory Bowel Diseases, namely Ulcerative Colitis and Crohn’s Disease. Our aim is to facilitate future scientific advancement and medical knowledge of these illnesses.

We recruit patient volunteers on behalf of and conduct clinical trials for, the pharmaceutical industry as well as international CRO’s.

Our clinical trials have full South African Health Products Regulatory Authority (SAHPRA) approval, as well as full Pharma Ethics approval.

Our staff are GCP accredited and include a gastroenterologist, general practitioner, nurse as well as a pharmacist.

Spoke Research Inc is situated in Milnerton, Cape Town.

In this blog article we will dig deeper into clinical trials, how the process works and what to expect.

What is a Clinical Trial?

A clinical trial is a research study that evaluates a new medical treatment.

These studies are done in phases, typically with three phases being the norm.

The first phase of clinical trials evaluates the drug for safety, to determine side effects.

The second phase measures the effectiveness of the drug against the illness, to determine side effects and start determining the dosage.  It is usually compared to a placebo or dummy drug, to see how well it works.

The final and third phase recruits more patient numbers, continues to assess the effectiveness of the drug against the illness, determine side effects and narrows down the correct dosage.

The trail drug is still usually compared to a placebo, or it can be compared against a drug already available on the market.  

Clinical trials are typically conducted by pharmaceutical companies.

How The Process Works

The process of how clinical trial works can be very complicated for people who are not familiar with the process.

Clinical trials are studies undertaken to decide whether a new medical treatment is safe and effective.

The purpose of these tests is to determine a medicine’s ability to eliminate or reduce the risk of certain diseases or conditions. A clinical trial must follow a strict protocol for safety and efficacy and must have full SAHPRA and Pharma Ethics approval.

The protocol defines the research, tests, and procedures that will be performed during the trial. The protocol is created by a team of experts who determine the design of the trial as well as its risks and benefits.

Challenges in Disease Management

Treating Inflammatory Bowel Disease remains a challenge because of the unknown causes, with no known cure.

While doctors previously suspected diet and stress to be the major causes, it is now known that these factors aggravate but don’t directly cause IBD.

The cure also remains elusive. Despite available treatments, many patients experience recurring symptoms.

This highlights the need for determining the appropriate and most effective treatment for specific patients. 

Doing Your Homework

Finding and enrolling in a Clinical trial may seem like a daunting process, but also an exciting option for those who are able to get through the required steps to successful enrollment.

There are many people who are interested in participating in clinical trials,but need more information or guidance.

Clinical trials are a chance for individuals to potentially help medical researchers find the best possible treatments and medications for diseases and illnesses.

But how do you know if a study is legitimate and trustworthy?

Follow these guidelines and you will be able to do your homework.

• Do your research and make sure that you are picking the right clinical trial that will best suit you and your health needs. It is best to discuss with your gastroenterologist regarding a Trial Center that can help you. It is also advisable to meet with the trial center staff to discuss the clinical trial drug and protocol in more detail. You can also search online and look for clinical trials in your geographical region. See what you can find out about the trial such as what condition it is for, any treatments or procedures.

• Decide on the trial based on the information provided.
  If you are not sure, speak to the staff at the trial center or your gastroenterologist. 

Succeeding at Clinical Trials

Firstly, as with all IBD treatments, it’s important to remember that clinical trials are a process.

It is a journey of a lifetime with a goal that is near and dear to your heart. It is a process that can be, and should be, approached with a positive attitude.

Clinical Trials at Spoke Research

We may have a Clinical Trial currently recruiting that is suitable for you.

Crohn’s Disease 

Signs and symptoms may include:

• Fever
• Fatigue
• Diarrhoea
• Abdominal pain and cramping
• Blood in your stool
• Mouth sores
• Reduced appetite and weight loss
• Inflammation of skin, eyes and joints
• Inflammation of the liver or bile ducts

When to see your doctor:

• Abdominal pain
• Blood in your stool
• Ongoing diarrhoea
• Unexplained weight loss or fever

If you are interested in helping us, find new treatments for Crohn’s Disease, please consider taking part in our clinical trials.

Apply for Crohn’s Disease Trial

Ulcerative Colitis

Ulcerative colitis symptoms can vary depending on the severity of inflammation and where it occurs.

Symptoms may include:

• Rectal pain
• Weight loss
• Fatigue
• Fever
• Diarrhoea
• Urgency
• Abdominal pain and cramping
• Rectal bleeding — passing small amount of blood with stool

When to see your doctor:

• Abdominal pain
• Blood in your stool
• Ongoing diarrhoea

If you are interested in helping us, find new treatments for Ulcerative Colitis, please consider taking part in our clinical trials.

Apply for Ulcerative Colitis Trial

Contact the Experts

Dr George and Dr Deetlefs are both clinical investigators at Spoke Research Inc.

Dr George became involved in Clinical Research in 2017, and now runs the Inflammatory Bowel Disease trials at Spoke Research Inc.

Dr Deetlefs has admitting rights and performs endoscopies at both Mediclinic Milnerton and Life Vincent Pallotti Hospitals in Cape Town.

We are here to provide you with expert medical advice in the field of clinical research with years of experience.

Contact us to find out more on clinical trials and treatment.