Investigator’s Initiated Trials (IITs)
The role of Independent Clinical Trials
Independent, patient-focused clinical studies, led by physicians play a vital role in improving and expanding patient’s care in the real world, regardless of commercial value. They are designed to enable research that has the potential to improve the treatment of disease, patient outcomes and the quality of healthcare. In particular IITs allow for:
- promoting innovative thinking
- exploring use of marketed drugs for new indications, in subsets of approved populations, in new combinations with other treatments
- providing pharmaceutical companies with clinical data for further understanding of their drugs in the real world
The challenge of Independent Clinical Trials
For an investigator, to start an IIT, requires more efforts in the preparation of the trial compared to running a pharmaceutical sponsored trial. He/she would need to design the protocol and calculate the necessary sample size for the trial. If there is no available research grant, he/she may need to submit a research grant proposal to the relevant funding organization to apply for a research grant to support the conduct of a trial.
Partnership with Exom Group will be most beneficial for the investigator. Exom Group, together with its team of medical writers and biostatisticians, will work with the investigator to design the study protocol and help to apply for the research grant to run the trial. Exom Group will assure a smooth an accurate running of the IIT from protocol writing, study feasibility, submissions, management and monitoring, to data management, and statistical analysis up to the final study report . Exom Group is well experienced in conducting international, high-quality independent clinical trials across the World.
Our focus areas include:
- Development of innovative drugs and medical devices
- Exploration of new indications for authorized drugs and medical devices
- Exploration of new disease management and managed care approaches
- Comparative assessment of efficacy and safety of approved healthcare strategies