Barriers to conducting clinical research in reproductive medicine: India

Barriers for conducting clinical trials in developing countries- a systematic review

“…One study [ 41 ] included seven countries (four from low and middle income countries (LMIC) and three from high income countries (HIC)), with a separate publication of the responses from each of the representatives of included countries. Therefore, we included the four papers from LMIC [ 42 – 45 ]. Two of the studies included in this review [ 40 , 41 ] were global studies.…”

“…For the majority of questions, all except one study [ 41 ] scored “good” for most criteria. The proposal [ 41 ] which led to publication of participants’ views from each represented country [ 42 – 45 ] did not present some important aspects of qualitative studies: the specific qualitative approach was not described and the research report did not describe the process of data collection, analysis and interpretation- Additional file 3 : Table S2.…”

“…Limited capacity in terms of funding were reported in all except two [ 52 , 53 ] studies conducted in Saudi Arabia [ 52 , 53 ]. Regarding human capacity, both lack of skilled personnel [ 40 , 42 , 44 , 45 , 48 – 50 , 52 , 53 ] and lack of awareness and of motivation to participate [ 43 , 45 , 48 , 49 , 52 , 53 ] were reported as barriers.…”

“…Delays in regulatory and ethical review were mentioned in most articles [ 40 , 42 , 45 , 46 , 48 , 49 , 52 ]. The time from initiation of all regulatory procedures to the actual start of the trial was very long.…”

“…Describing the exact period was not common but one study stated that it was not uncommon for grants to expire before all approvals were in place. Four articles reported that the presence of unskilled authorities in the review process posed a barrier to conducting clinical trials [ 42 , 45 , 48 , 49 ]. Over-complex and unreasonably strict ethical and regulatory systems were also reported in some articles [ 48 , 49 , 51 ].…”