Clinical Trials Explained

Clinical trials are an essential component of medical research that provide the foundation for the development of new treatments and interventions for a wide range of conditions, including inflammatory bowel disease (IBD).

By testing new therapies and treatment strategies, clinical trials help to unlock new possibilities for the management and potential cure of IBD.

Clinical trials offer several potential benefits for patients with IBD, including access to new and innovative treatments that may not be available through standard care.

Clinical trials can also provide patients with more frequent monitoring and care from healthcare professionals, which may improve their overall health and well-being.

In addition to providing patients with access to new treatments, clinical trials also contribute to medical knowledge about IBD. By gathering data on the safety and efficacy of new therapies, clinical trials help to advance our understanding of the disease and identify new approaches to treatment.

Overall, clinical trials play a critical role in the development of new treatments and interventions for IBD.

By participating in a clinical trial, patients can contribute to medical knowledge and gain access to new and potentially life-changing treatments.

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The primary goal of a clinical trial is to collect data and evidence to determine if the intervention is beneficial and safe for use in the target population.

The main purpose of clinical trials is to test their efficacy and safety in humans. They consist of five phases which are referred to as Phase 1-4.

Phase 1

This is the stage at which the first clinical trials are done among humans. The goal here is to ascertain how the new treatment is processed in the body and the various associated effects.

Less than fifteen people are used for this phase of the trial. If the medication acts differently to what was expected, then the researchers will normally undertake additional preclinical research.

Phase 2

The goal here is to understand the best dosage required to treat the illness while exhibiting the fewest side effects: the drug’s safety. Wisely, this is done on only a few patients – around fifteen to thirty.

Doses are started at very low concentrations for a few patients. Other patients may be given an increased dose until the desired effect is seen or the side effects become too severe to continue.

So, while the treatment can be beneficial to patients at this stage, Phase 1 is all about determining the safety of the treatment. If a drug is found to be safe enough, then it can be tested in Phase II of the trial.

Phase 3

The number of patients used in the clinical trial is greatly increased at this stage. It involves several hundred patients who live with the condition which the new drug or therapy is meant to treat. Dose-wise, they’re given what was found to be safe in Phase I.

The goal here is to understand the real-world drug efficacy.

Patients are monitored for a set period of time with the data garnered being crucial.

Some Phase 3 Trials

Compare how the new treatment compares to existing treatments for the same condition. To move on from this phase, researchers need to show that the treatment is at least as safe and effective as existing treatment options.

Clinical Trials at Spoke Research

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

Currently, we are specializing in “late phase 2 and 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 Ethics approval.

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

Spoke Research Inc is situated in Milnerton, Cape Town and was established in 2017.

Spoke Research conducts clinical trials to explore and develop more effective cures and treatments for inflammatory bowel disease.

If you have been diagnosed with Ulcerative Colitis or Crohn’s disease, you may be eligible to participate in our clinical trials.

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The Importance of Clinical Trials

Clinical trials play a crucial role in medical research, especially for chronic conditions like Crohn’s disease and Ulcerative Colitis.

They allow researchers to test new treatments, interventions, and diagnostic tools in a controlled environment.

By doing so, they ensure that the latest medical breakthroughs are safe, effective, and can potentially improve their lives.

Crohn’s Disease Explained

Crohn’s disease is a chronic inflammatory bowel disease (IBD) that primarily affects the gastrointestinal (GI) tract. It can involve any part of the GI tract from the mouth to the anus, but it most commonly affects the end of the small intestine (the ileum) and the beginning of the large intestine (the colon).

Ulcerative Colitis Explained

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that primarily affects the inner lining (mucosa) of the large intestine (colon) and rectum.

The inflammation in UC is continuous, usually starting from the rectum and extending upward, and typically involves only the innermost layer of the intestinal wall.

The Benefits of Participating in Clinical Trials

For patients with Crohn’s or Ulcerative Colitis, participating in clinical trials offers several benefits:

Access to cutting-edge treatments: Clinical trial participants have the opportunity to receive innovative treatments before they become widely available.
Close monitoring and expert care: During a clinical trial, participants receive close monitoring and care from a team of medical professionals specializing in IBD.

Contributing to medical knowledge: By participating in a clinical trial, patients contribute to the advancement of IBD research, potentially benefiting future generations living with the disease.

Conclusion

In conclusion, clinical trials are essential for the development and approval of new medical interventions, as they help ensure that new treatments are both safe and effective before being made widely available to the public.

Despite the lack of a cure, clinical trials have become essential in uncovering new possibilities for more effective treatments and management strategies.

These trials contribute significantly to the understanding of IBD and have led to remarkable advancements in areas such as novel therapies, personalized medicine, gut microbiome research, and stem cell therapy.

By participating in clinical trials, IBD patients not only gain access to cutting-edge treatments but also play an active role in advancing medical knowledge for future generations.

The continued efforts of researchers and the involvement of patients in clinical trials bring us closer to discovering better ways to manage IBD and, ultimately, finding a cure for this chronic condition.

Clinical trials play a vital role in the ongoing quest to understand, manage, and ultimately cure IBD.

As researchers continue to make strides in uncovering new treatments and interventions, the future looks brighter for those living with IBD.

By participating in clinical trials, patients have the opportunity to access cutting-edge care and contribute to the medical community’s understanding of this complex condition.

Currently we are recruiting patients for Crohn’s and Ulcerative colitis trials.

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

If you’d like to take part in a clinical trial, join us here:

Apply for Crohn’s Disease Trial

Apply for Ulcerative Colitis Trial

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