The prevalence of Crohn’s Disease (CD) is on the rise, impacting almost 500,000 people in America alone. CD falls under the category of Inflammatory Bowel Disease (IBD), characterized by recurring bouts of inflammation and irritation throughout any section along the gastrointestinal tract (GI). Such patients are at a greater risk for colon cancer whilst also being susceptible to additional complications like malnutrition issues or ulceration and obstruction within their intestines.
The treatment of Crohn’s Disease
The treatment for CD involves a combination of diet and nutrition improvements, surgery, and medication including amino salicylates, corticosteroids, and biologics. Despite multiple available options however, maintenance remission rates remain rather low at 30%-40%.
Henceforth, gastroenterology research personnel along with GI contract research organizations (CROs) are directing their efforts towards drug discovery in clinical development specifically aimed for those suffering from CD.
These ventures come with significant costs both financially and timewise. Consequently, outsourcing the services to CRO’s proficient GI team provides researchers with an external study support system coupled with specialized clinical trial infrastructure.
This strategy allows the sponsor companies to allocate their resources more productively toward driving future projects focusing on therapeutic treatments of CD.
There are five compelling arguments for why the use of GI CROs by sponsors is vital in conducting thriving clinical trials for Crohn’s Disease!
1. Increasing Recruitment Rates
Recruitment rates for clinical trials focused on CD have been decreasing annually between 1998 and 2018 due to the risk of being assigned to the control arm, as well as new treatment options becoming available.
Sponsors can counteract this trend by partnering with an experienced CRO that offers internal patient networks similar in nature to IQVIA CORE technology, Accellacare from ICON or our Clinic Trail Technology from Milo Healthcare. Moreover, GI CROs provide extra resources including tailored site protocol training sessions alongside digital marketing campaigns that improve user-friendly utilization of their clinical trial technology, resulting in enhanced enrollment and retention rates among patients involved in such studies.
2. Embracing Clinical Trial Designs That Are Non-Traditional
To address the challenges encountered in CD research, non-traditional strategies like adaptive or decentralized designs may be more appropriate. GI CROs have proven experience carrying out such studies and can guide sponsors on protocol customization to combat prevalent issues among target participants.
Adaptive design holds particular promise for countering recruitment difficulties because it allows dismissal of unresponsive dose arms to increase efficacy levels without compromising the total number of effective doses available. Switching over from traditional approaches could offer greater flexibility with potential saving worth millions but involve intricate planning that might add up cost-wise as well.
Collaborating with a specialized GI CRO conducting progressive trials empowers sponsor companies to fully utilize these tactics while making swift critical decisions at significantly reduced developmental expenses and time restrictiveness.
3. Streamlining technology for clinical trials is a priority
Sponsors often choose to outsource to a gastrointestinal contract research organization (GI CRO) primarily for the efficient conduct of their clinical trials. Leading companies such as Eclevar have innovated sophisticated data collection tools – ePRO, eSource, and EDC – which are unified in an easy-to-use suite with real-time communication across all platforms.
While CD or IBD/IBS studies may entail strenuous administrative tasks typically managed through antiquated paper-based systems, GI-CROs equipped with innovative digital products and vendor connections can offer electronic remedies that reduce costs significantly.
4. Global Regulatory Navigation is Essential for Success
Keeping pace with the ever-evolving regulatory requirements of federal agencies, such as the Food and Drug Administration (FDA), is essential for meeting the surging demand in GI trials.
This challenge becomes further compounded when conducting global multicenter studies where compliance must be upheld according to varying guidelines set by different countries’ jurisdictions.
Nevertheless, expert teams at GI CROs deliver tailor-made plans alongside sophisticated digital tools that facilitate adherence to present clinical trial regulations. To learn more about how these organizations offer strategies concerning regulatory compliance matters, read our article here.
5. Speeding Product Launch from Conception to Market is Crucial
Collaborating with a CRO in CD trials grants an exceptional benefit – they possess the necessary infrastructure to initiate projects upon signing contracts.
Sponsors facing individual challenges such as recruitment, fundraising or site preparation are prone to delays. Companies that avail of global facilities prove advantageous because relevant locations following local protocols would already be familiarized with them.
Ultimately, partnering with CROs simplifies process development for new drugs by offering detailed schematics for project plans complimented by pre-existing workflows and valuable guidance regarding crucial trial resources
CRO specializing in Gastroenterology
Managing Crohn’s Disease clinical trials can be a complicated endeavor, but partnering with the appropriate GI CRO will ensure that unexpected challenges are tackled proactively and swiftly.
With transparent communication and an unwavering commitment to accountability, Eclevar is – as a comprehensive GI CRO- leverages digital innovation to advance CD clinical research.
Our team of experts is trusted by top sponsors in the industry for providing affordable services without compromising quality or shortening study timelines while promoting patient-centric experiences throughout our clinical trial processes.
Contact one of our representatives today to learn how we can assist you!
