Figure 1. Schematic representations of (a) traditional sponsor-CRO interaction and (b) of a clinical development partnership.
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The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development
of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs.
Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical
development operations, or outsourcing the clinical development to contract research organizations (CROs).
A new strategy A new alternative strategy, which combines the best of the latter two options, has been used successfully over the past three
years and may represent a more attractive option to many biopharmaceutical companies. This solution requires a very close,
transparent, and flexible partnership with a provider of full clinical development services, with adequate measures and systems
to maintain sponsor control and awareness, high project focus by both parties, and very rapid response times owing to constant
and open communication. This type of partnership also offers significant opportunities for a transfer of know-how between
the partners. This can accelerate and improve the development process for emerging and growing biopharmaceutical companies.
Biopharmaceutical companies are incredibly successful at identifying drug candidates. Technological improvements, such as
high-throughput screening techniques and the rise of proteomics and genomics, have made this possible. At the same time, biopharmaceutical
companies have realized the need to move from technology platforms to product development to become the future players of
the new biopharmaceutical arena. Now, the challenge is to choose the best strategy to take their highest risk ever-bringing
drug candidates through clinical development.
Out-licensing Out-licensing the product or partnering with a large pharmaceutical company with a transfer of the clinical development responsibility
can be valid solutions, depending on a company's business model, product portfolio, marketing ambitions, and cash reserves.
By not taking the drug through clinical development, however, both options represent a lost opportunity for creating product
value. They should therefore be reserved for specific situations.
Internal clinical development A few companies choose to manage the clinical development of their product by hiring their own staff, often complementing
them with contracted individual resources. The main motivations usually are to keep close control of the clinical development
process and an expectation of lower development costs. While this certainly allows control and management of the clinical
trials, these companies face high initial and running fixed costs, which will rapidly escalate as development progresses.
Clinical development requires a variety of expertise and processes to conduct a large number of highly specialized, different
activities. No company can assemble such expertise and develop an entire set of processes that adhere to the ever-increasing
standards of international and national research in just a few months. Therefore, many of these companies actually lose time
(the cost of which is usually not accounted for) and struggle to conduct their programs at required quality levels. Secondly,
these considerations are complicated by the international nature of clinical development, which, to achieve efficiency, should
be conducted in specific countries based on such factors as product indication, clinical development phase, regulatory frame,
and local medical practices. By significantly increasing their fixed cost basis, these companies limit their ability to react
in the event of product failure. Thus, the clinical development costs of managing clinical development internally may actually
end up being much higher than when choosing an outsourcing strategy, and significant amounts of time may be lost.
Clinical outsourcing Most biopharmaceutical companies choose to outsource their clinical development program to one or several of the many available
CROs. Properly selected clinical CROs can indeed assemble experienced clinical research staff in diverse locations and provide
high-quality processes to conduct all clinical research functions in compliance with regulatory requirements. Three critical
factors for CRO selection are capability (available resources, experience in the therapeutic area, geographical location,
and nature of services), compatibility (of corporate cultures), and cost.1
However, the performance of CROs has come into question due to lack of clarity on pricing and control.2 Additional concerns have been expressed by emerging biopharmaceutical companies about the level of attention and commitment
received by their proportionally small projects in the midst of large CRO preferred-provider contracts with large pharmaceutical
companies. As a result, many of those companies regularly switch providers of clinical services and end up with significant
time lost and high costs to restart new collaborations for each study, study databases in noncompatible systems or formats
and in various locations, and a generally negative impression of CROs.
Measuring CRO performance has been the subject of several reviews, and various metrics have been proposed.3 While metrics are indeed essential in CRO performance assessment, various intangible elements of the sponsor-CRO interaction
remain critical to final sponsor satisfaction with the CRO. Some of these intangibles are flexibility, commitment, transparency,
and response time. Improvements in these areas have become essential for the CRO industry and are emerging with the new generation
of CROs, which support these key operating values with new technological solutions to provide instant access to high-quality
data and study progress information.4
The insufficient level of information exchange between CROs and sponsors (mostly perceived or interpreted as lack of transparency)
is a key element in clinical project delays. A very good knowledge of the process and of the progress of the clinical project
by the sponsor ensures fast reactions and decisions, facilitates sponsor-CRO interactions, and ensures a project-driven approach
that may result in saving months on the product's time to market. It is common knowledge that one month of delay in the time
it takes for a product to reach the market results in missed product sales of $25 million for a product that would achieve
peak sales of $300 million per year. The need for transparency is also absolutely essential to biopharmaceutical companies
with limited product portfolios due to the companies' high dependency on the product.
Historically, we have seen over and over again that the issues that arise on internally-run projects also arise on outsourced
projects. These situations very rapidly develop into scenarios of placing blame and pointing fingers, and people lose focus
from the task at hand-moving the project along.
If there is a spirit of close partnership with shared project teams and common goals, however, analysis of project issues
is done as a joint team, resulting in prompt actions, swift resolutions, and continued focus on the best interests of the
project.
From working together through the learning curve of the sponsor-service provider relationship, a sense of partnership will
develop, enhancing the feeling of a shared ultimate goal-successful product development.
