sRMDA Lab is involved the design and analytics support for a number of on-going clinical trials. Our research in clinical trials includes examination of affordable novel designs for answering important clinical questions
Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke (AcT)
This is a pragmatic, registry based, prospective, randomized (1:1) controlled, open-label parallel group clinical trial with blinded endpoint assessment of 1600 patients that examines if intravenous tenecteplase (0.25 mg/kg body weight, max dose 25 mg) is non-inferior to intravenous alteplase (0.9 mg/kg body weight) in patients with acute ischemic stroke otherwise eligible for intravenous thrombolysis as per standard care. All patients will have standard of care medical management on an acute stroke unit. Patients are being followed for approximately 90-120 days. This is the first pragmatic registry-based trial in acute stroke patients
PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2)
Injuries and resulting stiffness around joints, especially the elbow, have huge psychological effects by reducing quality of life through interference with normal daily activities such as feeding, dressing, grooming, and reaching for objects. Pre-clinical models and a pilot randomized clinical trial (RCT) demonstrated the feasibility and safety of using Ketotifen Fumarate (KF), a mast cell stabilizer to prevent elbow joint contractures. PERK2 is a phase III randomized, controlled, double-blinded multicentre trial parallel group (KF 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) study which enrolls over 700 adults with elbow fractures/dislocation enrolled within 7 days of injury. This study aims to evaluate the efficacy of KF in reducing joint contracture severity in adult participants with operately treated elbow fractures and/or dislocations.
Methodological Considerations for Design and Analysis of Registry-based Trials
RCTs are generally regarded as the highest form of evidence in medical research. Despite the numerous breakthroughs in medical research, RCTs are typically expensive to run due to issues with patient recruitment, follow up visits, and logistics. In addition, RCTs have limited generalizability of the results since patients were recruited based on strict inclusion and exclusion criteria, which might not represent of the entire population. Registries offer alternative and affordable alternative to facilitate patient recruitment and tracking of patient outcomes in RCTs. This program of research examines the methodological and operational issues that arises in the design of registry-based trials. We also examine other novel approaches for using registry-based trial infrastructure to promote novel trial designs that can address important clinical questions