The TIMI Study Group provides detailed guidance on optimal trial design based on decades of experience and driven by data gleaned from our over 60 trials. Unique to TIMI is that our Investigators, all of whom are staff cardiologists at Brigham and Women’s Hospital and on the faculty of Harvard Medical School, dedicate the majority of their time to their clinical trial work. Each trial thus has a dedicated team of cardiovascular clinical trialists and project managers who then work closely with the Sponsor to ensure the best trial possible to demonstrate an intervention’s efficacy and safety.
During the design phase we help develop the following vital elements of the trial:
- Electronic case report form
- Informed consent form
- Statistical analysis plan
- CEC charter (including endpoint definitions) and event reporting manual
We are happy to join the Sponsor at meetings with Regulatory Agencies as needed to review the protocol. We also identify members for the Independent Data Monitoring Committee and develop a draft of the charter for their review. We train the sites on the protocol and help develop study aids.
Once the trial launches, we work continuously to complete the trial quickly and efficiently, while ensuring the trial is always implemented to the highest quality standards. To that end, TIMI Investigators provide critical physician-to-physician guidance and motivation to the sites for both recruitment and retention. A Medical Hotline, staffed by TIMI physicians, is available 24/7 for any medical questions.
Once the database in locked, our Investigators and Biostatistical Team work in conjunction with the Sponsor to analyze the results and then disseminate the primary and secondary findings to the medical community. We also support the Sponsor during regulatory review as needed.