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Dan McDonald, vice president of business development for Excel Life Sciences, assesses the role of Site Management Organizations (SMOs) in India and discusses their contributions, which include GCP training and assistance for investigators.
Recently, there have been a number of industry articles and news pieces focusing on the growth of the clinical research market in India—specifically, the growth of CROs. What these articles fail to capture are a number of important points regarding the relevance and role of Site Management Organizations (SMOs) in helping the country deal with this rapid growth and ensuring that clinical research is being conducted following ICH-GCP and India-GCP standards. This is especially important in emerging markets such as India, where there are many investigators conducting clinical trials for the first time.
Dan McDonald Vice President Business Development Excel Life Sciences
The emergence of SMOs in India has helped to alleviate this concern by assisting investigators with day-to-day study conduct activities, ensuring that investigators are following the protocol, interacting with ethics committees, and helping to provide high-quality data from sites. In fact, the vast majority of trial data that has been accepted by the FDA for Indian trials has come from studies involving SMOs.
There is also deepening concern among regulatory bodies and sponsors related to hybrid companies that offer both CRO and SMO services in India, especially site monitoring services. These service offerings must remain distinct for several obvious reasons, the most important being that a single company cannot objectively monitor the performance of its own sites and coordinators when it has a stake in the outcome of the study. All of these factors help explain why the distinct SMO model is necessary, compelling, and thriving in India, despite its failures in other, more developed clinical research markets.
Outside of assisting the young Indian market with conducting regulatory and ethics compliant research, the model is proliferating for a number of other reasons. "The role of the SMO in helping to develop markets is a very important one," says Steve Hussey, managing director, PRTM Management Consultants (India) Pvt. Ltd. "In Japan, many of the improvements at the site level over the past several years can be attributed to SMOs. Specifically, enrollment problems cited by almost every global pharma relating to clinical trials have virtually disappeared."
Compared to the pool of highly qualified physicians, the number of ICH-GCP trained investigators is very low—no more than 800 by most estimates. The SMO model helps to alleviate this issue, with some of the top dedicated SMOs offering GCP training for investigators as part of their standard offering before getting physicians involved in a study.
The GCP issue is also alleviated through the placement of a dedicated, highly trained, and experienced clinical research coordinator at each investigative site to ensure that critical study conduct activities are carried out efficiently and effectively—taking the burden off very busy investigators. Without the support of a coordinator, many physicians do not have the bandwidth to take on clinical research.
"Clinicians in India are extremely busy and usually cannot afford to take sufficient time off to take care of all aspects of clinical trials," says Dr. Kannan M. Narayana, chief operating officer, Narayana Nethralaya Eye Hospital, Bangladore, and an investigator on a current study involving an SMO. "A site management organization is not only a necessity for busy clinicians but also ensures quality data management."
With the emergence of SMOs in India, clinical research sponsors that have had poor experiences contracting out investigative sites now have an organization to partner with that cannot only help them select qualified institutions and investigators for clinical trials but can also play a direct role in study conduct to help ensure a site's success.