Operational deficiencies during clinical trials in India and ways to ensure a smooth trial
For any company that seeks the opportunity to conduct clinical trials in India it is of great importance that a few things are in place. The regulations laid down by the law need to be followed along with the necessary approvals. We discuss the various operational deficiencies faced in India today.
The clinical trial industry has earned a lot of recognition for itself, due to which India has attracted a number of companies from all around the world to conduct clinical trials. Advantageous factors for India include huge population base, a large pool of patients, highly qualified scientists and medical professionals, and the most important factor – cheap cost. All these positive factors do come handy while conducting clinical trials but there are a few hurdles that the industry faces today.
Over the years, the cost of investment that goes into creating new drugs or biologicals is increasing due to global inflation. Due to this high cost incurred, the companies around the world are focusing on development of existing drugs with new dosage forms.
Norman Goldfarb conducted a quarterly review of clinical research industry in May 2011. According to his research, the industry is healthier than it was in the first quarter of 2010. This might be due to the steps taken by leading economies around the globe to reduce inflation and to improve the economic status. The Contract Research Organisation (CRO) market for phase I to phase IV trials represented about $ 7.8 billion in 2007 and is projected to grow to $ 17.2 billion in 2013. “Indiaprovides a number of significant advantages for the outsourcing of clinical trials because it offers a large patient population that facilitates faster recruitment, low trial cost per patient, a highly qualified professional medical community, plus global quality hospitals and clinical research facilities. Furthermore, with a highly developed IT and data collection capability and no language barrier,Indiahas become an important destination for clinical trials, and exponential growth is expected in the number of trials conducted there in the near future,” informs Dr Radheshyam Naik, Consultant, Medical Oncologist, HCG.
ThoughIndiahas a huge market available for clinical trials, there still exist a few logistical hurdles while conducting clinical trials. “Problems such as regulatory delays, availability of trained and experienced investigators, attitude of experienced investigators, ethics committee competence are being faced even today by the healthcare industry,” says Dr Arun Bhatt, President, Clininvent Research Pvt Ltd.
A few of the major problems faced by the clinical trial industry inIndiatoday include the following factors.
Adequate infrastructure including space, communication and data management equipment, archiving facilities, biological sample or investigator product storage facilities, uninterrupted electricity supply and more. It is of critical importance that all these factors are in place as they help in creating an appropriate environment for conducting clinical trials. “This is probably the easiest challenge to address as sponsors can set up facilities at newer sites, and identification of new investigators outside of the usual metropolitan sites is an attractive proposition,” explains Dr Naik.
Education and training
In India, there is a lack of potential investigators with fundamental knowledge of regulatory, ethical, Good Clinical Practice (GCP) guidelines to conduct clinical trials. Most of the medical institutes lack a formal course in training for clinical research, so there is a shortage of trained manpower.
Oversight of a clinical trial by an appropriate independent review board is mandatory for clinical research. These committees are responsible for safeguarding the rights and well-being of research participants by reviewing and approving the study protocol, performing periodic review of safety data and progress of the study. However, companies today face daunting challenges such as reluctance of individuals to serve on these committees, infrequent meetings, heavy workload, inadequate space and lack of administrative support. “These constraints not only lead to delays in approvals but also force most of the companies to restrict their activities to initial appraisal and approval of study protocol and documents,” says Dr Naik.
India is in the transition state; today regulatory approvals inIndiatake around 6- 9 months, whereas in the US it takes 30 days. Today, the regulatory frameworks have become stringent due to which a number of regulatory approvals are required before any clinical trial is conducted. The situation is getting more complex by the day. Thus, it is now more difficult for a clinical researcher to adhere to all regulations and guidelines. Central Drug Standards Control Organization (CDSCO) has released new draft guidance on approval of clinical trials and new drugs on July 24, 2011. Prior to that CDSCO has also approved a guideline on clinical trials inspection. Thus, regulations inIndiaare also becoming more stringent.
In India Hindi is the dominant language but it is still spoken by just a quarter of the people. There are many local languages that are being spoken all over the India. “This makes recruiting a patient population challenging and it becomes necessary to deliver clinical trial materials in multiple Indian languages. This is the point where it increases the importance of qualified translators in the market. Translations that are necessary for clinical trials are required to be certified,” explains Dr Naik.
Absence of effective price regulation
The Drug Controller General of India (DCGI) has permitted unrestricted and unregulated import of foreign finished formulations by traders. The registration and import of such medicines is done by local branches of foreign manufacturers. There is no control on cost of such medicines. Due to the absence of such price regulation, even when the cost of imported medicines has gone down Indian patients still continue to pay inflated prices. However, the development time in terms of drug pricing takes longer in India. A longer development time results in high R&D cost, which results in high drug prices. On the other hand, decrease in development time leads to decrease in cost. Some critics have urged that the situation is so bad that we need a new government agency that would change the conduct of all clinical trials, using the funds supplied by the manufacturers.
Clinical data management
Clinical trial outsourcing has just begun in India and the number of CROs is increasing in the country. To capitalise on the many opportunities that India has to offer, CROs must have a well structured IT system and a well-supported workflow strategy in place, which will allow greater co-ordination among sponsor, CRO and site. The CROs should also have good monitoring, clinical liaison and business-development functions available with them to oversee studies that are occurring in growing number of Indian cities.
Poised for greater growth
“We also need to streamline the process to make them transparent and to provide time bound clinical trial approvals in a reasonable time frame, balance medical coverage, creating societal awareness about the need for new drugs and clinical trials are a few areas that we need to work on in the future,” says Dr Bhatt.
Despite the challenges, India is well on its way to attracting high quality researchers and establishing itself as the global capital of clinical trials.
The regulatory system is being strengthened and laws are being amended to facilitate the conduct of clinical trials. There is a focussed effort to increase training of research professionals thereby generating a large base of investigators and supporting staff. India is poised to offer the global pharma industry high quality and cost-effective contract services to support drug discovery, clinical trial conduct, data management and manufacturing.