Clinical trial to implementation in India: Cost and effectiveness considerations for scaling up cervical cancer screening in low and middle income countries

Sujha SUBRAMANIAN, RTI International, United States
SANKARANARAYANAN R. 2 , ESMY P. 3 , THULASEEDHARAN J. 4 , SWAMINATHAN R. 5 , THOMAS S. 3

1 RTI International
2 WHO-IARC, France
3 Christian Fellowship Community Health Centre, Ambilikkai, Dindigul district, India
4 Sree Chithra Thirunal Medical Centre, Thiruvananthapuram, India
5 Cancer Institute (WIA), Chennai, India

Background:  There is a growing need to create the evidence-base for implementing and translating findings from clinical trials to make them operational and scalable. Several large and small clinical studies on cervical cancer screening have been conducted and lessons learned from these studies can be extrapolated to assess the cost and benefits of scaling up screening programs.
Methods:  We developed a detailed framework to translate the benefits, harms and costs from clinical trials to the real world setting. We used data from two large scale screening trials in India, the Dindigul and Osmanabad district studies, to draw inferences on the benefits and cost of implementing large scale screening programs using visual inspection with acetic acid (VIA). Compliance with screening and follow-up recommendations anticipated to occur in the real world setting (based on the Tamil Nadu Health System pilot study) were used to assess potential benefits and costs during scale up. Detailed activity based cost data that were categorized into fixed and variable components were used to determine costs related to scaling up screening.
Results:  The programmatic cost per women in the clinical trial was estimated to be $4-$6 while the screening delivery cost was about $11-$14. The cost per women with screen detected CIN or cervical cancer was $235-$314 in the screening trial; excluding programmatic costs it was $167-$223. Key issues in scaling up screening were related to compliance with diagnostic testing (56% in scale-up versus 98% in clinical trial) and ensuring high quality screens (requires systematic and ongoing training of providers).
Conclusions: Comparing total cost can be misleading as the resources expended on specific program activities impact access, quality and adherence to care and therefore overall program effectiveness. It is important to utilize activity-based costs and detailed performance indicators (provided in this study) to evaluate program effectiveness and cost-effectiveness.