ACRO Addresses India's Proposed IT-Enabled Clinical Trials System
In an effort to offer more function transparency, the Central Drugs Standard Control Organization (CDSCO) recently issued a proposal which outlined a new online system that would make clinical trials easier to monitor and faster to approve. Shortly after the release of this proposal, however, the Association of Clinical Research Organizations (ACRO) issued a statement which addressed questions the current proposal brought up and offered the organization’s expertise in streamlining and improving India’s proposed new system.
ACRO, an American clinical research organization (CRO), conducts thousands of clinical trials in more than 115 countries, including India, and has a vested interest in seeing the CDSCO’s proposal succeed.
According to the Statement, “ACRO welcomes and appreciates CDSCO’s issuance of the above-referenced Proposal and the commendable objective of bringing transparency to the clinical trial process in India. Availability of robust, transparent, functional systems and processes is a necessity for establishing a thriving clinical research environment in the country.”
ACRO’s statement went on to highlight concerns, ask for clarifications, and suggest improvements to the CDSCO’s seven part plan.
Among their chief concerns was patient privacy. India’s proposed system would gather and keep more data than any other similar system in the world, and according to ACRO, this is unnecessary. Furthermore, the CDSCO’s data requirements do not comply with data protection and employment laws already in place in India.
ACRO went on to suggest ways in which the CDSCO might correct these issues. In addition, they also suggested clearer timelines, ways of ensuring the security of collected information, and the appointment of an ombudsman — an official responsible for investigating any complaints the system might receive.
Overall, the organization remains optimistic about the CDSCO’s eventual success with what a spokesman from the CDSCO admits is a “work in progress.”
The statement, signed by Douglas Peddicord, executive director of ACRO, concluded the letter by saying, “We look forward to working with [CDSCO] to achieve regulatory framework that both ensures that the best interest of the patient is protected and provides an environment that is conducive to the development and evaluation of new medicines in India.”