Multidisciplinary Approach to Clinical Trials
Amy Lightner, S-ECCO Member
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Amy Lightner |
The increasing complexity of care for patients with Inflammatory Bowel Disease (IBD) has driven the need for multidisciplinary care. This has led centres and practices to hold regular multidisciplinary team meetings (MDTs) at which specialists in gastroenterology, surgery, radiology and pathology discuss patients. It has also led to joint clinics where practice environments allow patients to be seen by specialists in both gastroenterology and surgery, and even in some cases by experts in stoma therapy, nutrition and psychology, all on the same day. This allows for greater cross-disciplinary dialogue and more consistent messaging to the patient, which improves the quality of care and overall patient experience.
This same approach should be taken with clinical trials. Clinical trials of either investigational products or devices in patients with IBD involve the overall comprehensive care of the patients. Even if the clinical trial is an investigational drug study, where perhaps the surgeon is less relevant, the care of the patient remains multidisciplinary in nature. Study coordinators and primary investigators also become part of the patient care team. In addition, even if nutrition, stoma therapy and psychology are not among a clinical trial’s primary or secondary endpoints, they are still relevant to the overall well-being of the patient.
Other trials which have included surgeons and surgical endpoints, such as ADMIRE I [1], ADMIRE II [2], PISA-II [3] and LIR!C [4], have truly benefitted from an MDT approach. ADMIRE I and ADMIRE II for perianal fistulising Crohn’s Disease required patients to be optimised on medical therapy before undergoing surgical injection of an investigational product versus placebo at the time of examination under anaesthesia. PISA-II compared short-term anti-TNF treatment with surgical closure to long-term anti-TNF treatment. The LIR!C trial, which compared anti-TNF with early surgical intervention in Crohn’s patients with limited non- stricturing, non-penetrating terminal ileal disease, was truly multidisciplinary in nature, requiring both gastroenterologists and surgeons to answer fundamental questions about the optimal treatment algorithm for this disease phenotype.
Questions around optimal IBD care remain challenging, and continue to change on a regular basis as new drug approvals alter the overall treatment landscape. In order to answer the most critical, fundamental questions regarding IBD management, we must design studies to be conducted in a multidisciplinary fashion. And, ideally, before a study even starts, both gastroenterologists and surgeons will have been involved in designing it in such a way that it considers outcomes relevant to both specialties in conjunction. Thus, just as optimal clinical practice requires an MDT approach, optimal trial design requires an MDT approach to optimise the future incorporation of new drugs and devices into the MDT practice.
References
- Panés J, García-Olmo D, Van Assche G, et al.; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet 2016;388:1281–90.
- https://classic.clinicaltrials.gov/ct2/show/NCT03279081
- Meima-van Praag EM, van Rijn KL, Wasmann KATGM, et al. Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy in the treatment of perianal fistulas in Crohn's disease (PISA-II): a patient preference randomised trial. Lancet Gastroenterol Hepatol 2022;7:617–26.
- Ponsioen CY, de Groof EJ, Eshuis EJ, et al.; LIR!C study group. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial. Lancet Gastroenterol Hepatol. 2017;2:785–92. Erratum in: Lancet Gastroenterol Hepatol 2017;2:e7.