Site Management Organization: The Future
Introduction
The clinical trial is the most time consuming phase in the development of any new drug. In order to shorten this timeline, a large number of pharmaceutical companies now choose to outsource their clinical trials to a more professional clinical research organization. In addition, with the constant increase in the number and different types of trials based on treatment, prevention, early detection/detection, diagnosis, and quality of life/supportive care, the market for clinical trials is growing. at a very fast pace.
However, there are several challenges regarding this with patient recruitment and retention, conducting trials according to ICH-GCP guidelines, finding GCP-trained investigators, handling regulatory issues with country-specific requirements, providing high-quality data, meeting enrollment deadlines and therefore providing adequate research support becomes a daunting task. This is where the Site Management Organization (SMO) plays an important role, especially in emerging markets like India where the clinical trial market is growing at an astonishing rate.
Advantages India
• Large population of over a billion.
• Set of culturally, socioeconomically and genetically diverse population.
• Great treatment of the naive patient population.
• Availability of a large number of qualified and dedicated scientists and medical professionals
• Good command of the English language.
• Amendments to regulatory approvals, the patent law and schedule Y of the medicines and cosmetics law.
• Enhanced protection of human subjects, government protection initiative and FDA acceptance, improved data quality,
• Greater knowledge of ICH-GCP and other regulatory guidelines, cost advantage and having world class infrastructure.
market potential
The global CRO market in 2000 was USD 6.38 billion and increased to USD 23.65 billion in 2010. Based on 2006-2008 data, the CRO business has grown by 84% versus the world average of 12%. The number of clinical trial contracts has doubled in the last six months (800 to 1,560).
According to CDSCO, the Indian pharmaceutical market is worth $20 billion. Industry exports have jumped from $0.184 billion to $8.6 billion in the past two decades. The number of applications received/processed is from 10160 to 19088 from the year 2005-2009 with simultaneous increase in NDA. ANDA’s presentation is the second after the US These statistics ensure great business for SMOs that are growing at 50% in the country. The SMOs acquire 30% of the Rs 500 Crore registered by the CRO segment.
challenges
• Running a clinical trial is very expensive and time consuming in developed economies like North America, Europe and Latin America compared to India. The availability and recruitment of patients is also quite challenging in countries like USA. Statistics show that only 6% of eligible patients actually participate in the trial, as a result, 87% of trials are behind schedule with regarding your recruitment schedule. While in India, recruitment is three times faster and companies save 68% of the time on patient recruitment. However, their retention is a serious problem due to the lack of regular follow-up, protocol adherence and data quality.
• Trained GCP investigators and research staff are below the requirement. Statistics show that there were around 200-250 GCP trained researchers in 2002, which increased to 500-1000 in 2005. This reveals that a lack of GCP training exists among potential researchers. Choose a site that has a high influx of patients and is easily accessible with a well-developed transportation system.
• Many Pis 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 testing and site selection eventually. Some sites are not ready to give pre-feasibility questions with withholding key information.
• Budget negotiations and ethical issues in conducting a trial.
Solutions
• Recruitment of study subjects by researchers initiated in compliance with the protocol requirements. Retention of study subjects is accomplished by continual reminders and calls to subjects by study coordinators at scheduled visits and by looking after the well-being of patients.
• Training new young, dynamic and inexperienced site staff and updating existing staff with GCP guidelines, regulatory requirements, source documents, ICF, CRF, SAE reports and safety management and providing them with a complete understanding their responsibilities in conducting clinical trials. During on-site training, emphasize important points by considering specific protocol requirements.
• Provide a general feasibility questionnaire that provides complete information about the site, patient influx, total Pi’s available for each TA, and accessibility to the sites.
• Provide a study staff who can negotiate the budget as per the sponsor’s requirements and participate in ethics committee matters and thus communicate to the sponsor/CRO.
SMOs have greatly contributed to overcoming several clinical hurdles throughout the conduct of the study and thus have reassured the escalation of the market. Major pharma and CROs would greatly benefit from working with SMO for more productive research and providing a great cost advantage. Great apprehension regarding data quality and time factor in conducting clinical trials can be eased from now on by working with SMOs. An increasing number of hospitals, doctors and medical institutions provide a rich reach of SMO that expands its network across the country and even reaches Tier 2 cities. In short, SMO plays a key role in bridging the gap between site and the sponsor/CRO by accelerating patient enrollment and moving trials to the next phase faster.