SEDA trial includes patients with type C esophageal atresia, age ≥3 months, at their 3rd dilatation to prevent refractory stricture (sometimes defined as ≥5 dilatations)
ERNICA Research Collaboration Webinar in Clinical Trials
▶Ep 41 · 4:10
clinicalSEDA trial timeline: idea originated May 2017, ethical board approval January 2019, first patient included October 2019, 11th patient included 4 years after Rotterdam ethics approval↗
▶Ep 41 · 5:30
clinicalReaching consensus on SEDA protocol took more than 1.5 years involving pediatric surgery, pediatrics, gastroenterology, pharmacy, endocrinology, and radiology departments↗
▶Ep 41 · 7:00
guidelineSEDA trial chose not to include patients younger than 3 months due to stricter regulations for young children, despite missing some rare patients↗
▶Ep 41 · 10:00
epidemiologicalEthical approval from Medical Review Ethics Committee can cost easily €2000 or more per center, regardless of whether study includes 500 or 10 patients↗
▶Ep 41 · 11:00
clinicalClinical Trial Agreement (CTA) negotiations can take weeks to months, with one center taking almost 2 years before ethical approval could even start↗
▶Ep 41 · 12:00
clinicalSEDA trial budget of €750 per included patient covers research nurse, pharmacy, extra outpatient visits, additional esophagram, and travel costs, but not insurance, legal department, ethical approval, or translation costs↗
▶Ep 41 · 13:30
guidelineDifferent countries have different requirements: Sweden needs biobank approval for hair samples, Denmark has government-provided liability and subject insurance for all patients regardless of study participation↗
▶Ep 41 · 14:40
opinionCenters with a research nurse or PhD candidate are more likely to complete ethical board and legal department processes compared to centers where full-time clinicians must take responsibility↗
▶Ep 41 · 15:00
quoteexpect higher expenses than calculated. And even when you think you're expecting higher expenses, expect even more, um, and expect longer duration than calculated↗
▶Ep 41 · 1:03:00
clinicalSEDA trial includes patients with type C esophageal atresia, age ≥3 months, at their 3rd dilatation to prevent refractory stricture (sometimes defined as ≥5 dilatations)↗
