Centre's decision on clinical trials will enhance its overall

The Centre's recent decision to remove the cap on the number of clinical trials an investigator can undertake will enhance the overall quality of such trials in the country, a research body today said.
As per the revised rules put out on the Central Drugs Standard Control Organisation website, the cap on the number of trials an investigator can undertake at any point of time has been removed.
It has also been decided that the Ethics Committees will decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted. At the same time, the cap on a minimum number of 50 beds for a clinical trial site has also been revised.

"The earlier restrictions impacted a sponsor's ability to choose the best qualified investigators and sites for a study. Every investigator and site is unique in terms of their capacity, capability and infrastructure and therefore, their ability to do quality clinical research.
"The new announcements vest this decision with the Ethics Committees who are best positioned to deliberate on this and take a well calculated decision. We are pleased that the regulators have responded positively to stakeholder feedback," said Suneela Thatte, president of Indian Society for Clinical Research (ISCR).
What this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial and not by any arbitrary limits," Thatte said.

"As regards restrictions that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided...
"...That the Ethics Committee after examining the risk and complexity involved in the trial being conducted shall decide on how many trials an investigator can undertake," the circular signed by Drug Controller General G N Singh said.
A similar circular also said, "As regards condition that no clinical trial shall be conducted at a site having less than 50 bedded hospital, it has been decided that to revise the condition and the Ethics Committee shall examine and decide whether the clinical trial site is suitable for trial or not irrespective of the number of beds.