Table 1.
Consent refusals in various phases of clinical trials conducted in the department
| Scientific title of the study | CTRI Reg. No. | Ethics committee approval number | Type of the study | Sponsor | Consent refusals (n/Total counseled) (%) | Reason/s for consent refusal | Number of consent refusals n (%) |
|---|---|---|---|---|---|---|---|
| Pharmacokinetics of colistin, after intravenous administration of colistimethate sodium in subjects with nosocomial infections caused by multidrug resistant, gram negative bacilli | CTRI/2009/091/000252 | EC/PHARMA-38/2008 | Interventional (Phase IV) | Investigator-initiated | 0/16 | NA | NA |
| Open-label, randomized, dose escalation Phase I study in healthy adult volunteers to evaluate the safety and pharmacokinetics of a human monoclonal antibody to rabies (SII RMab) in comparison to human rabies immune globulin administered in conjunction with rabies vaccine (RABIVAX®) | CTRI/2009/091/000465 | EC/Pharma-35/2008 | Interventional (Phase I) | Pharmaceutical-sponsored | 16/162 (9.88) | Not ready to come for the follow-up visits | 16(9.88) |
| Three way, three period, cross over bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers | CTRI/2011/05/001709 | EC/Pharma-42/2010 | Interventional (Phase IV) | Pharmaceutical-sponsored | 2/24 (8.33) | Not ready to come for the follow-up visits | 2 (8.33) |
| A prospective study to assess the correlation between genotype, phenotype and Prakriti of an individual on phenytoin monotherapy | CTRI/2011/06/0011782 | EC/152/2010 | Observational | Investigator-initiated | 35/337 (10.38) | Extra blood draw | 35 (10.38) |
| A randomized, double blind, multicentric, placebo controlled, Phase II study assessing the safety and efficacy of intraarticular ex-vivo cultured adult allogeneic mesenchymal stem cells in patients with osteoarthritis of knee | CTRI/2011/07/001891 | EC/Pharma-25/2011 | Interventional (Phase II) | Pharmaceutical- sponsored | 0/11 (0) | NA | NA |
| A phase III, open label, randomized, parallel group, multicentric trial comparing the safety and efficacy of fixed dose combination tablets of arterolane maleate and piperaquine phosphate (PQP) with chloroquine tablets in patients with acute uncomplicated Plasmodium vivax malaria | CTRI/2011/11/002129 | EC/Pharma-26/2011 | Interventional (Phase III) | Pharmaceutical-sponsored | 93/145 (64.14) | Not ready for hospital admission Multiple blood collections Not ready to come for the follow up-visits | 67 (46.21) 22 (15.17) 4 (2.76) |
| A Phase II/III, randomized, multi-centric, comparator-controlled study of the safety and neutralizing activity of a human Monoclonal antibody to rabies (SII RMAb) Administered in conjunction with rabies vaccine for post-exposure prophylaxis in patients following potential rabies exposure | CTRI/2012/05/002709 | EC/Pharma-11/2011 | Interventional (Phase II/III) | Pharmaceutical- sponsored | 34/91 (37.36) | Safety concerns about the investigational product Objection for participation from family members Not ready to come for the follow-ups | 20 (21.97) 2 (2.20) 12 (13.19) |
| Evaluation of host immune responses and parasite proteome in healthy volunteers | CTRI/2013/08/003876 | EC/Govt-8/2012 | Observational | Investigator-initiated | 0/50 (Healthy volunteers) | NA | NA |
| Evaluation of host immune responses and parasite proteome in patients with severe/complicated malaria | CTRI/2013/08/003876 | EC/Govt-8/2012 | Observational | Investigator-initiated | 0/80 (Sever malaria patients) | NA | NA |
| A Phase 1, prospective, randomized, two-arm, active controlled, double-blind study to evaluate the safety and tolerability of Serum Institute of India’s 10-valent pneumococcal conjugate vaccine (SIILPCV10) in Healthy Indian young adults | CTRI/2013/ 09/003961 | EC/Pharma-8/2013 | Interventional (Phase I) | Pharmaceutical-sponsored | 26/60 (43.33) | Safety concerns about the investigational product Not ready to come for the follow up-visits | 20 (33.33) 6 (10) |
CTRI = Clinical Trials Registry — India