ABSTRACT
The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.
ABSTRACT
Ethics committee meetings are held periodically, with all members being physically present in the meeting room. During the COVID-19 pandemic, and the lockdown, a number of committees have resorted to the use of videoconferencing. Online meetings have significant advantages over physical or face-to-face meetings, though the guidelines and regulations imply that online meetings should not be the norm. Considering the advantages of online meetings in terms of saving time and costs, can the regulations and guidelines be tweaked to allow them even after the lockdown is over?
ABSTRACT
INTRODUCTION: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. METHODS: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years. RESULTS: It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). DISCUSSION: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.
