This week’s submission comes to us from Jim Worrell, CEO of Pharma Services Network. Since 2002, Pharma Services Network has helped biopharma sponsors find the right CRO partners with a growing emphasis on India.
Q. How popular is India as a country of choice for American or European sponsors?
A. India is becoming more and more popular each year as the adoption curve moves away from the early adopters to more mainstream. Having said that, there are still many sponsors that do not have full information about conducting trials in India, or do not have a partner they feel comfortable with. The clinical trial market is growing at 20%- 30% per year, and the Indian CROs are gaining a better understanding of how to best serve American sponsors.
Q. What are some of the advantages of conducting a study in India?
A. In many ways India is a very easy place to conduct clinical trials. Certainly India has access to large quantities of nearly all patient populations, and this represents one of the key reasons to initiate all or part of a clinical trial in India. Recruitment and enrollment are very fast not only due to the large number of patients but also to the concentration of patients with similar disease states in a central hospital. We have also found Indian patients to be more retentive, as clinical trials provide needed medical care without cost. Additionally, Investigators are highly motivated to participate in clinical studies to gain further access to leading edge medical technology and information.
In the past few years, the Indian government has greatly simplified the regulatory process for conducting Phase 2/3 studies in India, allowing some studies to receive government approval in as little as 30 days. Known as “Category A and Category B” studies, this new rule gives preferential treatment to any study that is currently ongoing in listed western countries. So, for example, if a US sponsor has sites up and running in the US, Canada, UK, Switzerland, or Australia, and requires additional patients, the Indian government will approve that CTA (Clinical Trial Application) within 30 days. Studies without this current history would fall into Category B and require approximately 70-90 days for approval.
Lastly, cost is a factor. Most studies run in India enjoy a per patient price of 30% – 40% below a similar study in the United States. However, unless there exists a well-defined feasibility study, price should not be the only reason to go to India.
Q. How about the disadvantages of conducting studies in India?
A. Due to the increasing demand for qualified Investigative sites in India, the competition is increasing, meaning that there is a higher demand for patients at “in-demand” investigator sites. This is especially true for the major Indications such as Diabetes, Hepatitis and a few Oncology centers. In general there is a lack of GCP certified Investigators, although the government has recently allocated US$10 million for the development of educational centers for clinical trial staff. So, sponsors need to be attentive to the CROs’ selection of Investigators to insure GCP certification and clinical trial experience.
Many US clinical operations staff who have been involved with Indian studies will advise you to have a good communication plan in place, and to work it diligently. Although India has excellent and highly skilled and trained clinical staff, the Indian business culture is different from the United States. Indians do not communicate as directly as many US sponsors wish they would, and in some cases communication is hampered by misunderstandings. Structured meetings with written agendas and written follow-up notes will help to keep this on track.
Lastly, US sponsors must recognize that “this isn’t Kansas anymore” and must accept delays as part of doing business in that part of the world. Experienced Indian CROs will build this into the schedule, as some delays in government documents, drug shipments, or communications are common. It is important for sponsors to have this expectation upfront, and to not lose their temper when these inevitable delays occur. As a good friend of mine said recently when experiencing short delays in an Indian study “we must teach the Indians and teach our own organization how to do business in India if we want to be competitive long term. It’s a learning process.”
As a side note, I have worked with several US sponsors who have slightly modified their internal SOPs in order to accommodate the Indian methodologies. This not only saved them weeks of time, but also put an end to superfluous meetings and discussions about how to handle instances that fall outside of normal SOPs.
Q. How would you characterize the Indian outsourcing market in general?
A. The first thing that comes to mind is “robust and growing rapidly”. Although there are several Indian CROs that have been in business for many years, and an equal number of American and European CROs with offices in India, there are still many Indian CROs that are just now fully addressing the Phase 2 / 3 market. Some of them are coming at it from the perspective of Data Management and pharmacovigilence, others are focusing on developing a specific network of quality Investigators, and still others are focusing on monitoring and project management. As American customers of these services, my hope is that we do not overlook these “newer” CROs, many who have been in business for 10, 15, or 20 years, but are just now addressing the Phase 2 /3 business. These CROs are knowledgeable, talented, and motivated to provide high value for American and European sponsors.
About Pharma Services Network
Pharma Services Network acts as an extension of your clinical department. Our clients count on us to help them identify and connect with CROs in both the USA and around the world. Typically, our clients are looking for CROs for the following reasons:
- Expertise in a particular therapeutic area or study design
- Access to unique patient populations, and often, treatment-naive patients
- Access to a particular geographic area with the thought of obtaining country-specific data
We provide sponsors with fast, easy access to leading specialty CROs and CSOs in virtually every country of the world. All of our service providers are pre-qualified based on stringent criteria including GCP / GLP, FDA audits, financial stability, past performance, and strong, sound management.
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Yes it is true that the cost of trials are lesser as compared to Western regulated markets. The main reason being the INR v/s USD & EU difference. But I also believe Indian PI’s are demanding as much equal compensation as their Western counterparts.
Also with the entry of globally acclaimed Central Labs like Quest Diagnostics and others would make Clinical Trial lab data coming out of India much more reliable and authentic due to higher benchmark for Validations and correlations with Global data.