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To understand that the studies are registered in India, you have to understand the prevalence rates of disease in the first place. Unfortunately, India does not occur in Today the powerful information through government or industry organizations to provide an accurate assessment of the prevalence and incidence of the disease. Instead, a more classic option should be done directly through the research sites. Many factors, including the novelty of some sites, customs cultural and trust require feasibility questionnaire to be distributed in person and the information gathered through an interview, rather than simply sending a form by fax or email. Use of an organization with staff throughout the country and with good contacts in each of the sites can make the process more efficient and often result in better data. As in the U.S., enrollment projections given by the Indian researchers typically must be reduced significantly, but often the overall projections are still much higher. Good viability data also include the frequency of meetings of each of the sites IRB (IRB some only can meet once every 2-3 months) and fees, also an important part of getting the study started quickly.
This hands-on process feasibility typically results in the selection of the best sites. But far greater importance is the need for ongoing support for each site to ensure prompt registration. As mentioned above, management companies are now sites help sponsors with the placement of highly qualified full-time CRC in each site to work alongside the researcher, revisions of files, tracking potential patients, projections and help manage behavior consent information among other things. This type of day to day support is essential to ensure the right of patients are enrolled.
About the Author:
Dan McDonald is Vice President of Business Strategy at Excel Life Sciences. With over 12 years of industry experience working with biopharmaceutical companies to assist them with their global clinical research strategies, patient recruitment and site selection and helping sites connect with sponsors. Prior to joining ELS Dan served as Sr. Vice President of Strategic Development for D. Anderson & Company a leading provider of global patient recruitment and retention services. The majority of Dan’s career in the industry was spent at Thomson CenterWatch, where he worked for nearly 9 years, and the last 3 as the General Manager* of that business. Dan also had organizational responsibility for Thomson NEIRB an independent institutional review board. Dan oversaw strategic planning and all day-to-day operations of the CenterWatch business for Thomson Healthcare and also was in charge of Sales and Marketing for Thomson Clinical Trials Solutions. He also oversaw the development and publication of several articles and strategic planning reports focused on the rapid growth of clinical research in emerging markets, primarily India, Central & Eastern Europe and China.
Mr. McDonald has conducted over 50 presentations at industry conferences and meetings, and he has conducted workshops and sessions on patient recruitment, emerging markets, clinical research in India and more.
Article Source: ArticlesBase.com – The Importance of Strong Study Feasibility on Patient Enrollment in India