The Importance of Strong Study Feasibility on Patient Enrollment in India

In order to understand which studies will enroll in India, you have to understand disease prevalence rates first. Unfortunately, India does not currently produce wide ranging information via government or industry organizations which will provide an accurate assessment of disease prevalence and incidence. Instead, a more classic feasibility must be conducted directly through the investigative sites. Many factors including newness of some sites, cultural customs and trust require the feasibility questionnaire to be distributed in person and information gathered through an interview rather than simply sending along a form via fax or email. Using an organization with personnel across the country and with good contacts at each of the sites can make the process more efficient and often result in better data. Like in the US, enrollment projections given by Indian investigators typically need to be scaled back considerably, but often the aggregate projections are still much higher. Good feasibility data will also include the meeting frequency of each sites IRBs (some IRBs may only meet once every 2-3 months) and the related fees, also an important part of getting the study up and running quickly.

This hands-on feasibility process typically results in the selection of better sites. But far greater in importance is the need for ongoing support of each site to ensure faster enrollment. As mentioned earlier, site management companies are now assisting sponsors with placement of a full time highly trained CRC at each site to work along side the investigator, conduct chart reviews, follow up with potential patients, conduct screenings and help administer informed consent among other things. This type of day-to-day support is essential to ensuring the right patients are enrolled.

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