Clinical trials are research studies that aim to discover new treatments, improve existing therapies, and enhance our understanding of various diseases.

For individuals living with Inflammatory Bowel Disease (IBD), including Crohn’s disease and ulcerative colitis, clinical trials can offer access to cutting-edge treatments and contribute to medical advancements.

This article will guide you through the process of finding and participating in IBD clinical trials, providing valuable insights into the benefits, risks, and steps involved.

Understanding IBD and the Role of Clinical Trials

Inflammatory Bowel Disease is a chronic condition characterized by inflammation of the gastrointestinal tract. The two main types of IBD are Crohn’s disease and ulcerative colitis.

Despite significant progress in understanding and treating IBD, many patients continue to experience symptoms and complications.

Clinical trials play a crucial role in developing new therapies and improving patient outcomes.

Clinical trials for IBD can investigate various aspects, including new medications, surgical techniques, dietary interventions, and lifestyle changes.

These trials are conducted in phases, each designed to answer specific research questions and ensure the safety and efficacy of the intervention.

Benefits of Participating in IBD Clinical Trials

Participating in a clinical trial can offer several benefits for individuals with IBD:

1. Access to New Treatments: Clinical trials provide access to novel therapies that are not yet available to the general public. This can be especially valuable for patients who have not responded to existing treatments.

2. Advanced Medical Care: Participants in clinical trials often receive close monitoring and comprehensive medical care from a team of specialists. This can lead to improved disease management and early detection of complications.

3. Contributing to Medical Research: By participating in a clinical trial, you contribute to the advancement of medical knowledge and help improve treatments for future generations of IBD patients.

4. Potential Cost Savings: In many cases, the costs associated with the trial, including medications and medical tests, are covered by the study sponsor. This can alleviate some financial burden for participants.
   
   

Finding IBD Clinical Trials

Finding a suitable clinical trial requires research and careful consideration. Here are steps to help you get started:

1. Consult Your Healthcare Provider: Start by discussing your interest in clinical trials with your gastroenterologist or primary care physician. They can provide valuable insights, recommend appropriate trials, and help you understand the potential benefits and risks.

2. Use Online Resources: Several websites and databases list ongoing clinical trials for IBD.
   Some reliable resources include:

   – Spokeresearch.co.za

   – Crohn’s & Colitis Foundation: This organization provides information on clinical trials, research updates, and patient resources.

3. Patient Advocacy Groups: Organizations like the Crohn’s & Colitis Foundation and local support groups often have information about ongoing trials and can connect you with research opportunities.

4. Talk to Other Patients: Connecting with other IBD patients who have participated in clinical trials can provide valuable insights and recommendations.

   Online forums and social media groups can be helpful in finding such connections.

Evaluating Clinical Trials

Not all clinical trials are the same, and it’s essential to evaluate them carefully before deciding to participate.

Consider the following factors:

1. Study Purpose and Design: Understand the primary goals of the trial and how it is designed. Is it testing a new medication, a combination of therapies, or a lifestyle intervention? Is it a randomized controlled trial, an observational study, or a pilot study?

2. Eligibility Criteria: Each trial has specific inclusion and exclusion criteria that determine who can participate. These criteria may include factors such as age, disease severity, previous treatments, and overall health.

3. Risks and Benefits: Assess the potential risks and benefits of participating in the trial. What are the possible side effects of the intervention? How might it impact your quality of life? Weigh these factors against the potential benefits of accessing new treatments and contributing to research.

4. Study Location and Duration: Consider the location of the trial and how often you will need to visit the study site. Some trials require frequent visits, while others may involve fewer trips.
   Additionally, understand the duration of the study and your commitment.

5. Informed Consent: Ensure you receive detailed information about the trial through the informed consent process. This document should outline the study’s purpose, procedures, potential risks and benefits, and your rights as a participant. Take the time to read and ask questions before signing.

Participating in an IBD Clinical Trial

Once you have identified a suitable clinical trial and decided to participate, the following steps will guide you through the process:

1. Screening and Enrollment: The first step is the screening process, where the study team will assess your eligibility based on the trial’s criteria. This may involve medical history reviews, physical exams, and diagnostic tests. If you meet the requirements, you will be enrolled in the study.

2. Baseline Assessments: Before starting the intervention, baseline assessments will be conducted to gather data on your current health status. These assessments may include blood tests, imaging studies, endoscopy, and questionnaires.

3. Intervention and Monitoring: During the trial, you will receive the assigned intervention, which could be a medication, therapy, or lifestyle change. The study team will closely monitor your progress through regular visits, tests, and assessments. It is crucial to follow the study protocol and report any side effects or changes in your condition.

4. Data Collection and Analysis: Throughout the trial, data will be collected and analyzed to evaluate the intervention’s safety and effectiveness. This data contributes to the overall research findings and may lead to the development of new treatments.

5. Follow-up and Post-Trial Care: After completing the trial, you may undergo follow-up assessments to monitor any long-term effects of the intervention. The study team will provide guidance on transitioning back to standard care and managing your condition.

Ethical Considerations and Safety

Clinical trials are conducted with strict ethical guidelines to ensure the safety and well-being of participants. Key ethical considerations include:

1. Informed Consent: Participants must provide informed consent before joining a trial. This ensures that you understand the study’s purpose, procedures, risks, and benefits.

2. Institutional Review Board (IRB) Approval: Clinical trials must be reviewed and approved by an IRB, an independent committee that ensures the study is ethical and protects participants’ rights.

3. Monitoring and Safety Protocols: Trials have safety protocols in place to monitor participants and address any adverse events promptly. Data Safety Monitoring Boards (DSMBs) may oversee the trial to ensure ongoing safety.

4. Participant Rights: You have the right to withdraw from a clinical trial at any time without penalty. Your decision to participate or withdraw should be voluntary and based on your best interests.

Conclusion

Participating in a clinical trial for IBD can be a rewarding experience, offering access to new treatments and contributing to medical advancements.

By following the steps outlined in this article, you can navigate the process of finding and participating in IBD clinical trials with confidence.

Remember to consult your healthcare provider, evaluate the trial carefully, and prioritize your well-being throughout the journey.

Clinical trials hold the promise of improving the lives of individuals with IBD and advancing our understanding of this complex condition.

Contact Dr. Gosia George

Dr Gosia George and Dr Eduan  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.

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