Clinical Trial Disclosure or Clinical Trial Transparency has been one of the widely discussed topics in the drug development process throughout the world. Though the concept of disclosure is as old as 1964, it has seen more traction and attention over the past decade. The systems and processes are relatively new and companies are catching up to it and have been an interesting subject for the CRO industry to support the client with the right solutions and knowledge. Let’s try to understand what exactly Clinical Trial Disclosure is and how it affects the stakeholder, right from the fresher level to the big pharmaceutical companies. In this blog, we will try to accomplish a basic level of understanding and the different activities under Trial Disclosure.
What is Clinical Trial Disclosure?
Clinical Trial Disclosures is a mandatory disclosure of the clinical trial outcomes and finding so that it can be refereed to at a future date by clinical trial professionals. As per the WHO, the disclosure of clinical trials includes registration of the trial before the first test is executed on the human. As per the disclosures, the key outcome is needed to be made public within 12 months of study completion and the main findings within 24 months.
Clinicaltrial.gov among others like EudraCT, German registry and CTRI is one of the major registry platforms for disclosing of clinical trial details. Currently the site lists 189,593 studies with locations in all 50 states and in 190 countries. With the drug authorities developing strict rules for non compliance, the movement has been gaining exposure but not without a resistance from the drug development companies.
Different Activities under TD?
As a CRO professional, there is an increasing need within the industry to develop skills and expertise in the relevant areas. The different activities under Trial Disclosure will give a synopsis of the job functions and the knowledge areas important to the professionals.
In the starting phase, a review of the protocols and disclosure readiness is made sure. After which the registration of the new studies is done of the registries mentioned above in a consistent manner.
Any change in the protocols during the execution of the clinical trials needs to be updated on a regular basis. Upon study completion, all the reports and prepared, reviewed and uploaded on the registry sites. Finally any entry into the sponsor’s software or any other custom system for public disclosure is taken up.
Through the activities seems to be regular tasks for the CROs, it is herculean task to be abreast with the amendments, acts and rules owing to the risk involved of non compliance. To achieve the above tasks in a seamless manner, the CRO companies and the respective professionals needs to be up to date with the regulations and the developments in the industry.
Trial Disclosure at MMS University
MMS University is providing a comprehensive course for the fresher and young professionals to enter into a career of Clinical trial disclosure with its one of its kind of assessment based certification program designed as per global standard. This course will provide hands-on experience with writing and reporting to global registries with a focus on Clinicaltrials.gov (US) and EudraCT (EMA).
MMS Holdings, a parent company of MMSU has been working with US and international sponsors to achieve comprehensive disclosure through its decades of experience. The same knowledge is now being disseminated through MMSU as an opportunity to the professionals to start or shift to the field of disclosures.
More on Disclosures
Disclosure is a vast topic to be covered in a single blog. We will cover the industry challenges, developments and job opportunities in the area of Clinical Trial Disclosure in the upcoming blogs.
Meanwhile, a industry inspired certification program can be attended at MMS University and the details can be viewed at TD Certification @ MMSU . Readers can also reach out to us at email@example.com