Inflammatory Bowel Disease Specialists
The QPS Clinical sites have significant experience conducting a wide range of Inflammatory Bowel Disease (IBD) studies. While patient recruitment can be a significant challenge, QPS can leverage our large volunteer database and in-house marketing agency to target actively interested clinical trial populations. This ensures that QPS is consistently a top enroller. QPS has conducted more than 70 clinical trials in Gastroenterology, and 9 of those trials studied ulcerative colitis and Crohn’s disease. We use a central IRB to ensure full regulatory compliance. Our full-time quality assurance and regulatory teams, rigorous standard operating procedures and experienced study coordinators consistently ensure quality results.
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Crohn disease is an inflammatory condition that can affect any portion of the gastrointestinal tract from the mouth to the perianal area. Its transmural inflammatory nature coupled with the variability of intestinal distribution (ie, which intestinal segment is affected) and systemic manifestations, gives rise to a spectrum of clinical presentations and long-term risks that have to be considered in deciding the optimal therapeutic approach.
Crohn’s disease can involve multiple layers of the bowel walls and occurs in patches, leaving some areas of the GI tract unaffected. Symptoms of Crohn’s disease can vary widely depending on the location and severity of the inflammation.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that primarily affects the colon (large intestine) and rectum. It causes long-lasting inflammation and sores (ulcers) in the innermost lining of the colon. The severity of the disease can vary, with periods of active symptoms (flares) and periods of remission. The exact cause of ulcerative colitis is unknown, but it is thought to result from an abnormal immune response where the immune system mistakenly attacks the cells in the digestive tract. Factors that may increase the risk include:
- Genetic predisposition (family history of IBD)
- Environmental factors
- Immune system malfunction
Challenges in IBD Clinical Trials
Conducting clinical trials for Crohn’s disease (CD) presents numerous challenges due to the disease’s complexity and variability. These challenges can impact various aspects of the trial process, from design and recruitment to data collection and interpretation.
1. Patient Recruitment and Retention
- Recruitment: The relatively low prevalence of ulcerative colitis and Crohn's disease limits the pool of potential participants.
- Retention: Maintaining participant engagement throughout the trial is challenging due to the chronic nature of UC, fluctuating symptoms, disease flare-ups, side effects and the length of trials.
2. Heterogeneity of Disease
- Variability in Presentation: Crohn's disease can affect any part of the GI tract and manifests with varying symptoms and severity among patients. UC varies greatly in severity, location of inflammation, and response to treatment. The variable nature of both of these diseases makes it hard to standardize and compare outcomes across different participants.
- Fluctuating Symptoms: UC and Crohn’s have periods of remission and flare-ups, complicating the assessment of treatment efficacy over time.
- Subtypes and Phenotypes: Differences in disease behavior and location necessitate tailored treatment approaches, complicating the design of clinical trials.
3. Complexity of Endpoints
- Objective vs. Subjective Measures: Clinical trials often use a combination of subjective symptom reports and objective measures. Assessing these subjective endpoints to accurately reflect disease activity and treatment efficacy is challenging. While endoscopic and histologic evaluations provide objective measures, they are invasive and costly, leading to less frequent use.
- Long-term Outcomes: Assessing long-term outcomes and disease progression requires extended follow-up periods, increasing the trial's complexity and cost.
4. Placebo Effect
- High Placebo Response: Both ulcerative colitis and Crohn's disease trials often see significant placebo responses, which can obscure the true efficacy of the investigational treatment.
5. Financial and Resource Constraints
- Ulcerative colitis and Crohn's disease trials are resource-intensive due to the need for specialized tests, long-term follow-up, and large sample sizes to account for disease variability.
To address the challenges in clinical trials for ulcerative colitis and crohn’s disease, researchers and clinicians are employing several innovative strategies:
- Improved Recruitment Methods: Utilizing patient registries, social media, and broader networks to enhance recruitment.
- Adaptive Trial Designs: Employing adaptive designs that allow for modifications based on interim results.
- Biomarkers and Precision Medicine: Identifying biomarkers to select appropriate patients and predict treatment response.
- Enhanced Patient Engagement: Providing education, support, and incentives to improve retention and adherence.
- Collaboration and Data Sharing: Collaborating across institutions and sharing data to enhance trial power and generalizability.
As of June 2024, there are over 1,000 clinical trials related to Crohn’s disease and over 700 related to ulcerative colitis registered on ClinicalTrials.gov. These trials vary in their phases, ranging from early Phase 1 trials to late Phase 4 trials, and they cover a wide spectrum of investigational treatments and interventions. These ongoing clinical trials include studies on new medications, combination therapies, alternative treatment approaches, long-term outcomes, quality of life, and lifestyle interventions.
The Main Classes of Drugs Currently Being Used to treat ulcerative colitis and Crohn’s Disease are Aminosalicylates (5-ASAs), Corticosteroids, Biologic Therapies (including Tumor Necrosis Factor (TNF inhibitors, Integrin Receptor Agonists and Interleukin (IL) inhibitors), Antibiotics, and Janus Kinase (JAK) Inhibitors. Surgery may also be necessary if drug treatment is not effective or if complications arise.
The choice of treatment depends on the severity and location of the disease, patient preferences, and the presence of any complications. Patients need to work closely with their healthcare providers to develop individualized treatment plans.
How is Cell and Gene Therapy Advancing Ulcerative Colitis and Crohn’s Disease treatment?
Cell and gene therapies for inflammatory bowel diseases (IBD) such as ulcerative colitis (UC) and Crohn’s disease (CD) are actively being researched and developed. Here are some of the approaches currently under investigation:
- Cell Therapy: Mesenchymal Stem Cells (MSCs) are being studied for their immunomodulatory effects, which could help reduce inflammation and promote tissue repair.
- Gene Therapy: Anti-inflammatory gene therapy approaches aim to deliver genes encoding anti-inflammatory proteins (e.g., interleukin-10) directly to the affected intestinal mucosa to suppress inflammation.
- Microbiome Modulation: Fecal Microbiota Transplantation (FMT) is not strictly a cell or gene therapy, FMT involves transferring fecal material from healthy donors to restore gut microbiota balance, which has shown some promise.
While cell and gene therapies for UC and Crohn’s disease are still in the investigational stages, they represent promising avenues for potentially transforming the treatment landscape of these chronic inflammatory conditions. Ongoing research and clinical trials are essential to validate these approaches and bring them to clinical practice.
Choose QPS for Your Next Inflammatory Bowel Disease Study
QPS specializes in a wide range of therapeutic area pharmaceutical research. Give QPS a call today to learn how we can manage your next clinical program.
