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International Clinical Trials
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The pharmaceutical industry is under growing pressure from the
complexities of the drug development process, hardening drug safety
standards, increased regulatory scrutiny and the ongoing patent cliff.
Indeed, it is estimated that $217 billion worth of originator products
will have lost patent protection by 2018, with $150 billion of this
amount predicted to be lost between 2010 and 2017 (1,2).
Leading
innovators are constantly looking for new ways to pick up this
shortfall – notably through emerging markets, which offer opportunities
due to their spending power, potential for high volumes and offshoring
capabilities. In addition, companies are looking to new strategies in
the product lifecycle process to bring products to market faster. Better
quality data and analyses are setting the stage for more rapid,
informed decisions.
Given that only about 9% of all therapies
will be approved in early clinical studies – with many being lost due to
outdated and impractical trial designs (3) – this is an area in which
significant improvements can be made in cost, quality and resources.
Outsourcing Model
Successful
pharma companies are now thinking more strategically about their global
business models, and over the last decade have increasingly turned to
outsourcing to achieve their organisational and R&D goals. Business
process organisations (BPOs), knowledge process organisations (KPOs),
scientific process organisations (SPOs) and CROs have been integral in
addressing the industry challenges through providing clinical
development services, such as clinical operations, data management, pharmacovigilance, regulatory operations and statistical programming (4,5).
Statistical
programming and analysis – or biometrics – requires a niche skill for
service delivery. A globally distributed model for this activity has
distinct advantages when it is effectively managed offshore. This
article outlines the requirements and reasoning behind outsourcing this
activity – particularly in emerging markets – and what is required to
sustain and optimise it.
Statistical Activities
Inaccurate
analysis and inappropriate study design can make or break a clinical
trial, lead to wrong conclusions, and potentially result in significant
cost and resource wastage. It is therefore essential to the success of
the development programme to get the design and analysis of the trial
correct.
Biostatistics and statistical programming now accounts
for around 7% of total clinical trial costs, with the outsourcing of
this function having risen by 20% during the past three years (6). The
reason for this is growing internal costs, the requirement for
computational and analytics capabilities, and the mature domain
capabilities that BPOs, CROs, SPOs and KPOs can offer. Pharma companies
that partner with service providers stand to gain up to 50% cost
advantage through globally networked delivery (6).
Statistical
activities are primarily performed in-house or through on-site or
onshore consultants, due to the required level of skill and experience
available in emerging markets. The small amount of offshoring for
statistical activities that occurs is mainly limited to captive units
that pharma firms have established in countries such as India and China.
Only a handful of service providers have the required expertise and
experience to deliver complex statistical services from emerging
markets.
Clinical Programming
However,
considerations for clinical programming are different. Due to the
maturity the IT outsourcing industry had reached by the start of this
century, pharma companies were keen to use the available infrastructure
and resources to get their clinical trial programming work completed in a
cost-effective manner through a globally distributed model. Clinical
programming is still a highly resource-intensive activity, especially
with the focus on validation and quality control checks at every step of
the process. Offshore delivery teams can help to meet these demands
through access to a large talent pool and by using the 'follow-the-sun'
model – a type of global workflow in which tasks are passed daily
between work sites that are across many time zones in order to reduce
project duration and improve responsiveness.
While offering
increasingly good infrastructure in emerging markets, BPOs, KPOs, SPOs
and CROs can provide the niche skill sets and computational
capabilities, together with better cost structures. Statistical
programming is more challenging to deliver from an emerging geography
than less complex work related to database programming, safety reporting
or data mapping.
Selection of the outsourcing vendor should be
largely guided by the complexity of the tasks being offshored. It is
important to understand how the process should be sustained and
optimised to successfully achieve the desired objectives.
Resource Balance
An
initial consideration for pharma companies when offshoring programming
work is maintaining a balanced mix of in-house and on-site resources
versus offshore resources. Getting these numbers right during each phase
of outsourcing is crucial. This will ensure there is enough
in-house/on-site/onshore capacity available to provide mentoring and
oversight as capability is being built within the offshore team, and
also while productivity of the offshore team is ramping up.
Managing
peaks and troughs, both in the onshore and the offshore requirement, is
easier if contract resources are available at both locations. A good
partner that can provide flex capacity offshore – instead of having only
a captive team offshore and some contract resources onshore (in
addition to a core in-house team) – will address this need.
Alongside
this, it is also vital to consider the right kind of work to assign to
the offshore group, and how it needs to change over time. Rather than
allowing work to be sent through as it arrives, it is recommended that
tasks assigned to the offshore group are carefully planned so as to
gradually increase the complexity of their work, to match with the
gradual build of the capability.
Ability and acceptance of the
in-house and onshore teams to manage change should be continually
monitored, especially with respect to changes in the type of work they
do – for instance, providing more oversight and taking on strategic
responsibilities, over being mostly focused on operational tasks.
Optimising Productivity
Productivity
is an essential element of ensuring a streamlined, effective and
efficient working system, and should not be overlooked when moving into
new markets and working with international teams. There is a need to
think beyond just ensuring the required levels of technical competence
and functional expertise. Making sure desired levels of engagement and
involvement within the offshore team are maintained, whether it is the
captive group or a service provider, can make a real difference in this
area. Various measures to achieve this – including on-site opportunities
and involvement in end-to-end projects, rather than discrete and
isolated tasks spread across several projects – should be considered.
In
addition, there must be frequent communication with the offshore team,
so that the distance and remoteness can be overcome as much as possible.
Time zone differences can make constant communication more demanding,
and it should always be top of mind.
The type of work assigned
and the role on projects has to factor in the time difference to ensure
optimal productivity. If used efficiently and correctly, time difference
can also be worked to advantage and lead to enhanced productivity. The
follow-the-sun model is well-accepted in today’s globalised environment,
and has yielded clear benefits for many businesses. The same applies to
the programming and analysis aspects of clinical trials, especially
when there is a need to crunch the timelines for an interim analysis or a
regulatory submission.
Sustaining Success
Once
optimal productivity has been reached, sustaining productivity levels is
top of a sponsor's and service provider's priorities. In order to
ensure that productivity remains optimised, it is essential to define,
measure and track metrics to monitor the success of the engagement.
With
such evaluation procedures in place, along with mutually agreed
targets, it is possible to gain a thorough understanding of the health
of the engagement and recognise any problems before they become
critical. While setting expectations and defining service-level
agreements, it must be recognised that capability in emerging markets
has to be built over a period of time.
Another aspect of
sustaining productivity levels is hiring and developing the right staff
within the teams. The average staff profile in emerging markets is often
different from what companies may be used to in developed markets with
mature drug development services. This group may have unique needs for
professional growth and development. A continued focus on training will
ensure all parties achieve the best possible results from the start.
Maintaining
trained and productive workers is also important for managing volume
fluctuations, and ensuring speed and quality. The demand-supply skew in
emerging markets cannot be ignored. A certain level of attrition has to
be assumed and there should be a strategy – such as a ready pool or
buffer resources – to mitigate any risk to the business.
True Partnership
There
are clear benefits to pharma companies that outsource clinical trial
related statistical programming and analysis. By carefully employing an
offshore strategy, improvements can be made in terms of availability of
skilled resources, quality of analysis and adherence to timelines that
will ultimately help companies make faster and more informed decisions
at the right time.
Companies do, however, need to recognise that,
while the emerging customer base and potential spending power is a huge
incentive to those wishing to break into emerging markets, there are
other considerations which should guide the decision to outsource these
services. To optimise and sustain delivery, the key lies in selecting
the right vendor and bringing in teams – remotely and onshore – that
work well together in a cohesive manner to meet company objectives.
In
can be a complex process to bring in external resources and then manage
them effectively. This can be achieved by maintaining a balanced mix of
resources, both onshore and offshore. It is essential that the
importance of optimising and sustaining productivity is not
underestimated once these teams are in place. Success will only come if
the customer and the vendor work jointly in true partnership towards the
common goal of continued effectiveness of the globally distributed
model.
References
1. Insights into pharmaceuticals
and medical products – Generating value in generics: Finding the next
five years of growth, McKinsey & Company, May 2013
2. Global generic
pharmaceutical market – Qualitative and quantitative analysis, Frost
& Sullivan, presented at PharmaTech Conference 2013. Visit:
www.slideshare.net/aiswariyachidambaram/pharma-tech-2013- aiswariya-chidambaram-fs
3. What is the probability of success of
clinical trials?, Clinuity Blog, 2011. Visit:
http://clinuity.com/blog/2011/02/what-is-the-probabilityof-success-of-clinical-trials
4. Outsourcing in the pharmaceutical
industry: 2011 and beyond, KPMG, 2011. Visit:
www.kpmg.com/ca/en/issuesandinsights/articlespublications/documents/outsourcing-pharmaceuticalindustry.pdf
5. Khan I, Competent statistical programmer: Need of business process outsourcing industry, Perspectives in Clinical Research 5(3): pp95-100, 2014
6. Sherlaker S et al, (P)re-scribing the innovation pathway, TATA Consultancy Services White Paper, 2013
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Boston, MA, 17 May 2022 – Dotmatics, a leader in R&D
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