Clinical trials: Will the boom sustain?

Pharma MNCs and CROs have been able to conduct good quality clinical trials in India despite several hurdles because of availability of professionals and their willingness to comply with regulations and standards in true spirit, says Sanjay Gupta

In today’s scientific era research is taking a major stride in all streams and newer and better drugs are being introduced to cure ailments, which are difficult to treat. Clinical trials are the mainstay for bringing out new drugs to the market and constitute approximately 70 per cent of the total time and money spent in drug development. Typically it takes approximately 12 years and 800 million USD to bring one new drug from conception to market.

In the present IPR regime, patent for a drug is valid for 20 years of which a significant amount of time is spent in development alone. This, in turn, is posing the biggest challenge to the pharmaceutical industry worldwide and they have started adopting new and collaborative outsourcing strategies to optimise the innovation and increase efficiencies.

India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, wide spectrum of disease, lower cost of operations and favourable economic and IP environment etc. The overall time and cost advantage in bringing a drug to the market by leveraging India could be as high as 200 million USD. This is evident by steadily increasing number of global studies in India over past two years.

A Mckinsey report projects the potential clinical research outsourcing opportunity to be around 1.5-2 billion USD by the year 2010. Contract Research Organisations (CRO) are fast gaining importance because of their global presence, specialised local expertise as well as competitive pricing strategies and a significant number of new CROs have set up their operations in India over the past couple of years. However, some key barriers stand in way of opportunities that includes regulatory framework, patient’s rights and safety, infrastructure, ethics committees, data quality and lack of training curriculums on clinical research etc.

Most of these barriers are common to all developing countries and need to be addressed in a similar way. Without addressing these challenges it would be really difficult to capitalise the opportunity that comes our way in totality. A lot has been written about these challenges already and most of us feel that somebody will come and resolve them for us. Now the question comes, is clinical research here to stay or is it just a soap bubble?

The answer lies within the question itself, that it can be either; depending on whatever we choose out of the two.

Clinical research would certainly be a soap bubble if we feel that:

• We would comply to the GCP and applicable regulatory guidelines only in the presence of a robust regulatory inspection system
• Patients need not know of their rights and safety as a research subject and administering ICD is just a routine clinical trial procedure
• Routine hospital practice and standards can meet the infrastructure requirements (like labs, drug storage, archival, access control etc) of global trials
• Ethics committees are there just to approve the trial protocol and may not comply with the ICH-GCP and/or ICMR guidelines on their charter and responsibilities
• We can’t generate good quality authentic data
• Source data (patient’s medical records) can be modified anytime without audit trial and may not be presented in original for certain critical analysis parameters
• Access control to source document (hospital file/records) cannot be established and it cannot be archived for the specified duration under proper environmental control
• Any of the clinical trial activity can be undertaken by personnel with out having the required training or technical know-how.

On the contrary, clinical trials are there to stay if all the stakeholders like sponsor(s), CRO(s), investigator(s), ERB(s) and regulatory authority (ies) can observe a self-discipline while carrying out their respective responsibilities.

Most of the multinational pharmaceutical companies and CRO(s) are able to conduct good quality clinical trials in India despite all these hurdles. The only reason they could do so is because of the required professional training and their willingness to comply with the regulations and applicable standards in ‘true spirits.’

Ethical companies set globally consistent standards and conduct trials only in the countries where GCP compliance is assured. India has demonstrated that by virtue of its participation in more than 50 global trials so far. It’s time now that we should change our mindsets from ‘situational ethics’ to ‘holistic ethics’ and if we could do so there is no reason why clinical research won’t become the most sought after industry of the next decade.

The writer is Director, Clinical Operations, Catalyst Clinical Services Pvt. Ltd. E-mail: sanjay@catalystclinicalservices.com