, head of clinical management, PPD,
is head of clinical management for PPD in India. He holds a
post-graduation in pharmaceutical biotechnology. Sundriyal has more
than nine years of experience in clinical research and has worked in
vast therapeutic areas such as oncology, neurology, dermatology and
Today, India is poised as a preferred location for conducting global
clinical trials due to the inherent advantages of cost, speed and
quality associated with the overall development of a drug.
India’s success is evident by the sheer numbers of clinical trials
happening in the country, which is projected to reach 15 percent of all
global clinical trials over the next five years.
India’s total clinical trials market is estimated to reach
crore ($2 billion) by 2012, and pharmaceutical companies are
outsourcing much of this work to contract research organizations.
CROs are fast gaining importance because of their global presence,
specialized local and therapeutic expertise, and competitive pricing
strategies. A significant number of new CROs have established
operations in India over the past few years, and many pharmaceutical
and biotech companies are viewing CROs as strategic partners.
Though guidelines for conducting global clinical trials remains uniform
(ICH-GCP guidelines), interpretation of these guidelines changes to
comply with applicable regulatory requirements in a given country.
These changes pose great challenges for CROs. Since a CRO customizes
its operations based on a sponsor’s
specific requirements, it must account for cultural and procedural
There are many challenges for CROs in India:
1. Variable standard operating
In the absence of uniform standard operating procedures (SOPs) across
companies, various working procedures change from company to company.
It becomes particularly difficult when there are different procedures
required by different sponsors for CROs working with the same
investigator on the same activity. For example, considering the
procedure of Informed Consent Form (ICF) administration, some sponsors
require only an impartial witness to sign the document, if a study
subject is unable to sign by himself/herself, yet other sponsors may
require a legally acceptable representative, to sign the ICF document
on behalf of the study subject.
In addition, various documentation requirements for critical trial
activities vary among sponsors. Requirement changes may create
confusion for investigator site personnel, leading to more deviations.
When questioned on variable SOPs by site personnel, CROs must base
their response on the sponsor’s requirements. Investigator sites often
fail to understand why there is a non-uniform interpretation of
so-called uniform guidelines.
2.Contractual obligations and
The clinical trial agreement (CTA), which is executed between a trial
sponsor and investigator site, is another element that creates
difficulties for CROs. While in some cases a CRO is considered a party
to the CTA, in a majority of the cases agreements are executed
only between the sponsor and the site. Hence, most of the time, a CRO
does not have control over contractual obligations set forth between
the sponsor and trial site.
However, the CRO is held fully-accountable on contractual obligations
by both sponsors and investigator sites. Whether it is schedule of
payments or utilization of study/administrative grant, a CRO may be in
a difficult position to maintain agreement between the sponsor and
3. Publication policy
This area is the most common element of disagreement between
investigator sites and CROs. There is no publication policy in a
majority of trials. In the absence of a clearly defined policy, a CRO
struggles to address this issue effectively with investigator sites.
Though the authorship in a trial publication is directly linked to the
contribution made by an investigator, there have been instances where
Indian investigators have been excluded from providing authorship in
spite of being among the highest recruiters for patients worldwide.
4. Inexperienced CROs
The growth in the clinical research industry has led to the operation
of CROs that do not have a serious understanding of clinical research.
Many of them are set-up for short-term gains rather than being a
long-term partner in developing this sector in the country. Often these
organizations do not have sufficient well-trained, qualified employees
and lack the processes, systems and infrastructure to conduct quality
5. Development of new investigator
Sponsors often prefer to work with investigator sites that can devote
time to its study and that are not already participating in too many
clinical trials. With the sudden rise in the number of clinical trials
being conducted in India, most trained investigator sites have been
saturated with multiple studies, which are creating quality issues.
CROs, like sponsors, want to work with sites that have prior clinical
trial experience. It is a challenge for CROs to identify trained sites
that are not currently participating in many studies.
As an alternative, CROs need to identify new investigator sites and
train staff on international guidelines and procedures to ensure
quality in conducting clinical trials. Scaling of new investigator
sites toward global clinical research, requires investment of
additional time and efforts by the CROs. India continues to be a
competitive place for conducting trials and to ensure that quality
training takes place, CROs need to assume additional investments at
their own cost.
6. Archival of study documents
After the completion of a clinical trial, there is a requirement for
archiving study documents for a specified period of time. This time
frame varies from 10 to 20 years across the industry.
Since CROs often approach investigator sites on behalf of multiple
sponsors, they are under pressure to provide the archival
facility/space. This issue may lead to delays in initiating new trials,
therefore CROs must often work out alternate archival arrangements for
the trial sites, at their own cost.
7. Attrition rate and trained staff
High turnover rates in the rapidly growing Indian clinical research
industry are posing a challenge for CROs. To retain employees, CROs
must offer competitive compensation packages while ensuring projects
are properly resourced. Currently, there is a shortage of approximately
50,000 trained personnel in India’s clinical research industry.
A key success factor of any clinical trial depends on how well an
investigator has assumed his/her role, therefore, it is important that
other sponsors and CROs develop a consistent and collaborative working
environment with investigators. Whether it requires bringing harmony in
operating procedures, or a uniform interpretation of regulatory
guidelines; initiatives taken by sponsors and CROs will go a long way
to ensure the successful execution of global clinical trials in India.
Recent initiatives led by the Drug Information Association aim to bring
uniformity in the taxonomy of trial files to the industry for uniform
Some of the sites have started electronic archival of study documents,
but validation of the archival process as per CFR Part 11 is still a
challenge. The Drug Controller General of India has taken some
initiatives like CRO registration, that is still in draft stage. A
similar initiative for bringing uniformity in working procedures seems
For India to remain a key to the global clinical trials market,
pharmaceutical companies, CROs and investigator sites need to work
together closely, to address these challenges, which will bring greater
quality and efficiency to conducting global research in the country.