Site Management Organization – The Future
December 1, 2017
Clinical trial is the most time consuming phase in development of any new drug. In order to reduce this time line large numbers of pharmaceutical companies now choose to outsource their clinical trials to a more professional clinical research organization. Furthermore, with ever increase in number and different types of trials based on treatment, prevention, early detection/screening, diagnostic and quality of life/supportive care, clinical trial market is growing at a very rapid pace.
However, there are several challenges in regards to this with patient recruitment and retention, conducting trials as per ICH-GCP guidelines, finding GCP trained investigators, handling regulatory issues with specific country requirements, providing high quality data, meeting enrollment timelines and thereby providing adequate research support becomes a daunting task. This is where Site Management Organization (SMO) plays a major role especially within emerging markets like India, where clinical trial market is growing at an astonishing rate.
• Large population of more than 1 billion.
• Cultural, socio-economic, genetically diverse population pool.
• Huge treatment of naive patient population.
• Availability of large number of qualified dedicated scientists and medical professionals
• Good command over English language.
• Amendments to regulatory approvals, patent act and schedule Y under drugs & cosmetics act.
• Improved human subject protection, protective government initiative and FDA acceptance, improved quality of data,
• Increased awareness for ICH-GCP and other regulatory guidelines, cost advantage and having world class infrastructure.
The global CRO market in 2000 was 6.38 billion USD and rose to 23.65 billion USD in 2010. As per the data from 2006-2008, CRO business has grown 84% as against the global average of 12%. The numbers of clinical trial contracts have doubled in last six months (800 to 1560).
As per CDSCO the Indian Pharmaceutical market is worth 20 billion USD. The industry exports has jumped from 0.184 billion USD to 8.6 billion USD in last two decades. The number of applications received/processed is 10160 to 19088 from the year 2005-2009 with simultaneous increase in NDA. The ANDA filing is second to USA. These statistics ensures a great business for SMO’s which are growing at 50% in the country. The SMO’s acquire 30% of the Rs 500 Crore recorded by CRO segment.
• Conduction of a clinical trial is very expensive and time consuming in developed economies like North America, Europe, and Latin America as compared to India. The availability and recruitment of patients is also quite challenging in countries like US. Statistics show that only 6% of eligible patients actually participate in the trial, as a result 87% of the trials are behind their recruitment schedule. Whereas in India recruitment is three fold faster with companies saving 68% of time in recruiting patients. But, their retention is a serious issue due to lack of regular follow up, protocol adherence, and data quality.
• Trained GCP investigators and research staff is below the requirement. Statistics show that there were around 200-250 GCP trained investigators in 2002 which rose to 500-1000 in 2005. This reveals that lack of GCP training is there among potential investigators. Choosing a site which has a large inflow of patients and is easily accessible with a well developed transportation system.
• Many Pi’s are preloaded with many clinical trials and don’t have time for any new trials.
• As different countries have different regulations, meeting those regulatory requirements becomes a daunting task for a trial and selection of sites eventually. Some sites are not ready to give pre-feasibility questions withholding key information.
• Budget negotiations and ethical issues in conduct of a trial.
• Recruitment of study subjects by initiating investigators in adherence to protocol requirements. Retention of study subjects is done by continuous reminders and calls to the subjects by the study coordinators at scheduled visits and taking care of patients well being.
• Training of young, dynamic and inexperienced new site staff and updating existing staff with GCP guidelines, regulatory requirements, source documents, ICF, CRF, SAE reporting and safety management and providing them with complete understanding of their responsibilities in conducting clinical trials. During site training emphasizing on important points while considering protocol specific requirements.
• Providing a general feasibility questionnaire that gives complete information about the site, patient’s inflow, total Pi’s available for each TA and accessibility to sites.
• Providing a study personnel who can negotiate budget as per the sponsor requirements and participate in ethical committee issues and thereby communicating the same to Sponsor/CRO.
SMO’s have made enormous contribution in overcoming several clinical hurdles throughout the conduct of the study and thus reassuring escalation of the market. Pharma majors and CRO’s would greatly benefit working with SMO’s for more productive research and providing extensive cost advantage. The much apprehension regarding quality of data and time factor in conduct of clinical trial can henceforth be reassured in working with the SMO’s. An ever increasing number of hospitals, doctors and medical institutions provide a rich scope of SMO’s expanding their network throughout the country and reaching even to tier-2 cities. In summary, SMO plays a key role in bridging the gap between Site and Sponsor/CRO accelerating the patient enrollment and taking trials to next phase faster.