The biomedical sector is evolving to facilitate the trial process and hasten the distribution of pharmaceutical items to the general public. A milestone in these advancements came in the form of master protocols, also referred to as platform trials, were introduced by specific guidelines issued by the U.S. Food and Drug Administration (FDA) in 2019. Master protocols are documented strategies for multiple purposes targeting improved patient centricity and speedy clinical trial research. Clinical trial management systems have been completely transformed through master protocols.
A Type of Master Protocol — Platform Trials
Out of the three main categorizations for master protocols, platform trials are trials designed to follow the same protocol but with the potential to evaluate multiple diseases or treatments at a time. The other two categories of master protocols include basket and umbrella trials.
Advantages of Using Platform Trials
Platform trials and master protocols can produce more effective results than traditional clinical trial protocols.
- Multiple Treatment Options: Several treatment options can be evaluated for the same pool of people providing high-quality insightful data to the research organizations proving to be time effective and productive.
- Less Time-Consuming: They share many similarities with the conventional study design of the clinical trials, except that multiple treatment options or diseases are simultaneously evaluated within the setup. Participants might have to sign documentation separately for each option being evaluated.
- Using a Common Control Group: Regulatory bodies allow the use of a common control group for platform trials and master protocols to increase the efficiency of the trial outcome. Using a common control group is an enticing and feasible option that the sponsors can readily utilize to finance the budgeting of the trial to suitable ranges effectively.
Streamline Your Trial Now
Many sponsors and research organizations observe and employ the benefits platform trials and master protocols bring to the biomedical industry. But utilizing such an advanced study strategy leads to an influx of data that can be difficult to handle. At Clinical PURSUIT, we realize the importance of clinical trial management systems and how one error can lead to devasting failures. With our powerful EDC system in place, we ensure no such errors occur, and data is streamlined as smoothly as possible.
Contact us now to ensure that the integrity of your data stays in its top quality.
