India's changing clinical trials scene

Bahri, Charu

doi:10.1016/s0140-6736(16)32461-8

“…And in 2016 it was noted that a clinician had simultaneously run 10-15 trials in the country [28]. In our analysis, one PI in the India-only set (who had run 39 trials) and two in the India-etc set (33 and 44 trials, respectively) had exceeded the number 25, although it is not known how many of these trials ran simultaneously.…”

Section: Details Of Principal Investigatormentioning

confidence: 64%

“…One needs to be concerned about a given PI running many trials in India. It is known that the specialist:patient ratio in India is poor [28], and it is also widely acknowledged that the workload on Indian doctors can be extremely heavy. This gives rise to the apprehension that a doctor may not be able to take adequate care of the participants in multiple trials.…”

Section: Details Of Principal Investigatormentioning

confidence: 99%

An analysis of certain fields of interventional drug trials registered with Clinical Trials Registry – India

Pillamarapu

¹

,

Mohan

²

,

Saberwal

³

2019

Preprint

0

View full text Add to dashboard Cite

Background There has been a significant increase in the number of trials registered with Clinical Trials Registry – India (CTRI) recently. We therefore wished to understand the current landscape of interventional, drug trials that have run in India. Methods We downloaded all trial records on 4 April 2018, and queried the data after it was formatted into an SQLite database. We distinguished trials hosted by India (India-only trials) and those co-hosted by India and other countries (India-etc trials). Results We analyzed eight fields of data, with the following key results: (a) Year of registration: The India-etc set suffered a serious dip in 2013. Both sets increased sharply in 2017. (b) Phase: Phase 3 trials were the most common in both sets of data, but were manifold more common in the India-etc set. 30% of the India-only trials had no phase information. (c) Trial sites: Four states each account for 50% or more of the sites in both sets of data. Also, 7–8 cities accounted for 50% or more sites in both sets. (d) Ethics committees: Over 70% of India-only trials had a single ethics committee, but the India-etc trials had a much greater spread. For each set, the maximum exceeded 60 committees per trial. (e) Principal Investigator (PI): 84% and 73% of PIs in the India-only and India-etc sets, respectively, had run a single trial each. One PI had run as many as 44 trials. (f) Primary sponsors: global pharma companies sponsored less than 5% of the India-only set but 92% of the India-etc set. (g) Fraction of subjects from India in India-etc trials: An abnormally large fraction of participants are not recruited from India. (h) Countries co-hosting the India-etc trials: The pattern was similar to that found for international trials co-hosted by Australia. Conclusions It is important to understand the landscape of trials being run in any country, to understand the recent past, in case of any red flags, and to serve as inputs to changes in policy. The data also serves as a baseline for the future, to ascertain the impacts of new policies, locally or globally.

show abstract

“…In 2011, it was noted with concern that there was a PI who had run as many as 25 trials in India [27]. And in 2016 it was noted that a clinician had simultaneously run 10-15 trials in the country [28]. In our analysis, one PI in the India-only set (who had run 39 trials) and two in the India-etc set (33 and 44 trials, respectively) had exceeded the number 25, although it is not known how many of these trials ran simultaneously.…”

Section: Details Of Principal Investigatormentioning

confidence: 99%

“…There are many problems with how trials are run in India [14,28,34], but on the face of it, for trials being co-hosted by India and one or more other countries, the identity of co-host countries, and the pattern of co-hosting trials is similar to that of a major Western nation, that is Australia.…”

Section: Details Of the Countries Co-hosting The India-etc Trialsmentioning

confidence: 99%

An analysis of certain fields of interventional drug trials registered with Clinical Trials Registry – India

Pillamarapu

¹

,

Mohan

²

,

Saberwal

³

2019

Preprint

0

View full text Add to dashboard Cite

Background There has been a significant increase in the number of trials registered with Clinical Trials Registry – India (CTRI) recently. We therefore wished to understand the current landscape of interventional, drug trials that have run in India. Methods We downloaded all trial records on 4 April 2018, and queried the data after it was formatted into an SQLite database. We distinguished trials hosted by India (India-only trials) and those co-hosted by India and other countries (India-etc trials). Results We analyzed eight fields of data, with the following key results: (a) Year of registration: The India-etc set suffered a serious dip in 2013. Both sets increased sharply in 2017. (b) Phase: Phase 3 trials were the most common in both sets of data, but were manifold more common in the India-etc set. 30% of the India-only trials had no phase information. (c) Trial sites: Four states each account for 50% or more of the sites in both sets of data. Also, 7–8 cities accounted for 50% or more sites in both sets. (d) Ethics committees: Over 70% of India-only trials had a single ethics committee, but the India-etc trials had a much greater spread. For each set, the maximum exceeded 60 committees per trial. (e) Principal Investigator (PI): 84% and 73% of PIs in the India-only and India-etc sets, respectively, had run a single trial each. One PI had run as many as 44 trials. (f) Primary sponsors: global pharma companies sponsored less than 5% of the India-only set but 92% of the India-etc set. (g) Fraction of subjects from India in India-etc trials: An abnormally large fraction of participants are not recruited from India. (h) Countries co-hosting the India-etc trials: The pattern was similar to that found for international trials co-hosted by Australia. Conclusions It is important to understand the landscape of trials being run in any country, to understand the recent past, in case of any red flags, and to serve as inputs to changes in policy. The data also serves as a baseline for the future, to ascertain the impacts of new policies, locally or globally.

show abstract