Crohn’s disease (CD) affects nearly half a million individuals across the United States, and its incidence is only increasing. CD is a common subtype of chronic inflammatory bowel disease (IBD), and patients with this diagnosis suffer from intermittent episodes of irritation and inflammation, which can occur in any part of the gastrointestinal (GI) tract. These patients are not only at a higher risk of developing colon cancer, but they’re vulnerable to complications such as ulcers, malnutrition, intestinal obstruction, and more.
Treating Crohn’s Disease
Today, CD can be treated with a combination of diet and nutrition improvements, surgery, and medication, such as aminosalicylates, corticosteroids, and biologics. However, despite the abundance of available treatment options, remission rates during maintenance are still only around 30%-40%. Therefore, gastroenterology researchers and GI contract research organizations (CROs) are increasingly investing their resources into drug discovery and clinical drug development for CD. These projects come with significant costs, in time and money. By outsourcing to a CRO’s experienced GI team, researchers can provide external study support and specialized clinical trial infrastructure. This then frees sponsor companies to invest their spare resources into driving future projects in CD therapy.
Here are five reasons why sponsors utilizing GI CROs is essential for running successful Crohn’s disease clinical trials!
1 | Raising Recruitment Rates
Due to the availability of new treatment options, as well as the risk of being assigned to the control arm, recruitment rates for CD clinical trials have been decreasing annually between 1998 and 2018. By partnering with an experienced CRO, sponsors can gain access to their internal site or patient networks similar to IQVIA CORE technology, ICON’s Accellacare, and Vial’s Preferred Site Network. GI CROs can also provide additional resources such as tailored site protocol training, initiate digital marketing campaigns, and implement user-friendly clinical trial technology to improve patient enrollment and retention rates.
2 | Embracing Non-Traditional Clinical Trial Designs
The difficulties seen in CD research may be better suited to non-traditional approaches, such as adaptive or decentralized designs. Many GI CROs are already experienced with conducting these types of studies and can help sponsors navigate how to tailor their protocol to address common issues with the target population. For example, given the recruitment challenges of CD, adaptive designs, in particular, can be beneficial because unresponsive dosing arms can potentially be dropped to increase the number of effective doses. These approaches offer sponsors flexibility that could save them millions of dollars, but they are not simple or cheap to plan. Consultations from GI CROs who specialize in running progressive studies can enable sponsors to take advantage of these designs and make critical decisions with greater efficiency and speed.
3 | Streamlining Clinical Trial Technology
One of the main reasons sponsors will outsource to a GI CRO is to gain a potential benefit in efficiency when conducting their clinical trial. Modern companies like IQVIA and Vial have developed advanced data capture tools, like ePRO, eSource, and EDC, which are integrated into one user-friendly suite built with real-time cross-talk between platforms. CD and IBD/IBS trials, in general, can come with heavy administrative burdens, but GI CROs with existing digital products and vendor relationships can provide an electronic solution to costly, outdated paper-based methods.
4 | Navigating the Global Regulatory Landscape
The rapidly increasing interest in GI trials must keep up with ever-shifting requirements set forth by federal agencies like the Food and Drug Administration (FDA). This is especially challenging in the case of global multicentre studies because sponsors must ensure proper compliance in accordance with the regulatory guidelines of different countries. However, GI CRO expert teams provide specialized plans and digital tools to keep up with the current clinical trial regulatory landscape. Read more about the regulatory compliance strategies CROs can offer in our article here.
5 | Reducing Time to Market
One of the greatest advantages of enlisting the expertise of a CRO in CD trials is that they already possess the infrastructure to begin a project as soon as the contract is signed. On their own, sponsors would face delays because of the time commitments needed for hiring, fundraising, or preparing sites. Companies that demonstrate a global reach are especially beneficial because they already have facilities located in target locations familiar with their local trial regulations. CRO partnerships ultimately streamline the development process for new CD drugs by providing detailed project plans, pre-existing workflows, and valuable trial guidance and resources.
The Vial Gastroenterology (GI) CRO
Crohn’s disease clinical trials can be complex to manage, but the right GI CRO will proactively handle unexpected issues with quick responses, transparent communication, and with a sense of accountability. Vial is a full-service GI CRO that offers digital innovation and is committed to advancing CD clinical research. Our experts are trusted by leading sponsors to deliver shorter study timelines, quality affordable services, and a clinical trial experience that puts you first. Contact a team member today to discover how we can help!
