Randomised controlled trials in India: a systematic mapping

Background

Evidence from randomised controlled trials (RCTs) is vital for enabling healthcare providers and policymakers to make informed decisions about healthcare. RCTs are considered the ‘gold standard’ for evaluating the effectiveness of interventions because they represent the highest level of evidence due to the ability to control bias at multiple levels.

The applicability and generalisability of evidence generated in other parts of the world to India has limitations. As such high quality RCTs are required to improve clinical care and build a culture of evidence-based medicines. With resources being limited there is a need to prioritise funding decisions. To inform research prioritisation and science policy related to clinical trials there is a need to understand the landscape of existing randomised controlled trials.

Aim

To systematically map randomised controlled trials (RCTs) from India

Method

We will identify published RCTs conducted among Indians, irrespective of the type of intervention of health condition. We will search for RCTs in multiple electronic database . We will undertake a quantitative analysis or synthesize data narratively, where appropriate. Using this information, we will create a landscape of published clinical trials. We will analyze trends over time, distribution by health condition, region, type of interventions , outcomes and other key characteristics .

Potential Impact

The mapping of RCTs would help in assessing the extent, range and nature of research, and identifying gaps in the evidence to aid the planning prioritising of future research clinical trials in India