Essential Role of CROs in Pakistan
Pakistan is an emergent market economy with excellent prospects beckoning at its doorstep. Clinical research is one that has now entered most of South and SE Asia save some unfortunate countries hamstrung by poor governance or absorbed in political imbroglios with Pakistan heading this list.
Despite an incredible talent pool in the health and life sciences sector among others that are making headlines for themselves and native country in the developed world, life for those left behind is humdrum to put it mildly. We can attribute several reasons for this dilemma such as those noted in the first paragraph, others being economic mismanagement, poor planning, lack of foresight, lagging health regulations and educational infrastructure, lack of investment in human resource development, plus several others.
Most research is indigenous being conducted at health, private and public institutions without proper governmental financial support or vigilance which in itself tells volumes about our people’s ambition and of their unique achievements. Some local and MNC pharmaceutical companies are also conducting research studies or participating in global studies which are laudable and encouraging.
In this article role of CROs will be introduced to enable those keen on clinical research or those eager on advancing research at their hospitals, institutions, pharmaceutical and device companies to appreciate how they may better conduct clinical research as per international norms and standards with support of specialists on their side.
Before proceeding any further an explanation of the terms CRO and outsourcing is warranted.
What is a Contract Research Organization (CRO)?
A CRO can be described as an organization/person that is contracted by a sponsor to manage various steps in the drug development process, including conduct of preclinical studies, clinical study design and execution, data management, analysis, medical writing, and regulatory submission.
Services provided by a CRO
The types of services may be one or many or full-service provider CROs may offer an exhaustive list of core and ancillary R&D services. Listed below are services that from a practical aspect are more applicable to Pakistan in the near term:
- Drug development (including nutraceuticals and herbal medicines)
- Preclinical testing
- Clinical trial/study management
- Biostatistical Analysis
- Data management Laboratory services
- Bioequivalence studies
- Post-marketing surveillance / Observational studies
- Regulatory affairs consultation
- Medical writing (i.e. protocol, clinical study reports, publication)
- ++ many other niche services
Types of Relationships
- Preferred Vendors: Sponsor directs business to selected short-listed CROs
- Functional Service Providers (FSPs): Sponsor selects CROs on basis of specific capabilities Risk sharing: CRO shares risk and reward with Sponsor on project-by-project basis
- Technology Partnership: CRO offer third-party developed technology to clients
- Drug licensing: CRO conducts drug research for its own products
The phenomenon of outsourcing became popular more so in the 90’s and is continuing to date This enables CROs provides their specialized services on a for fee for service basis based on the
Definition “The strategic use of outside resources to perform activities traditionally handled by Internal staff and resources”.
It is a trend for pharmaceutical companies to contract third parties to conduct their clinical trials in order to test their drugs This trend is referred to as ‘outsourcing’, and the companies that carry out the work are called ‘contract research organizations’ (CROs) In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle income countries.
There are several reasons and mostly it is due to prevalent global economic recession and down-sizing all revolving around seeking avenues of revenue generation and optimization.
Other reasons are as follows:
Lack of internal capacity / expertise
Strategy / policy to outsource certain programs
Focus on operations
Allow sponsor to focus on its core competencies
The CRO Advantage
CROs bring with them a wealth of experience of working with many different products, regulatory regions, organizations and quality systems, which allows them to quickly integrate into the operations of the sponsor organization. It allows the sponsor to quickly take advantage of different markets and opportunities due the immediate availability of expert personnel, knowledge and equipment. This avoids the need for the sponsor to invest in capital equipment
or hire specialist staff. The costs of projects are agreed in advance, therefore the cost of development is defined at the outset and the cost of a project can be directly controlled. These relationships also allow a company to expand into, or take advantage of, technologies that are not its traditional expertise.
CROs being businesses themselves may penalize sponsors in the event of unforeseen circumstances such as early termination of projects, delays or additional requirements (translating into additional costs). However, if a sponsor can manage a project in a manner that
results in minimization of long term R&D expenses while containing short-term costs, they will obtain a net advantage in hiring on services of a CRO.
CROs Worldwide Presence
The CRO sector is highly fragmented with over 1,100 CROs worldwide, although more than two thirds of all CROs are based in the US. CROs come in many shapes and sizes: some are specialized in certain services in certain areas (the small specialty CROs), and some offer the whole spectrum of services in a drug development process around the world. This latter group comprises the global full service CROs, which have a presence in all emerging markets. Of the major global CROs, Quintiles is the market leader, with 14% of the global market share; followed by Covance and Pharmaceutical Product Development (PPD), which hold 10% each of the market share (see Table below). The five largest CROs hold 45% of the total market between them.
Nearly 70% of the total research and development (R&D) costs are spent on clinical trials.
Clinical trials are a key factor in the rising R&D costs because today’s drug trials are larger and more complicated on average and require more participants than ever before. In addition, recruiting participants is becoming more difficult in western countries. In 2008, US Pharma companies spent $32.2 billion on trials. Pharmaceutical companies are under pressure to bring more new drugs to the market while at the same time they have to cut their R&D budgets. As a result, companies are increasingly outsourcing their R&D to Contract Research Organizations (CROs), which offer services that can increase R&D effectiveness and at lower costs. Currently, about half of the clinical trial activities are outsourced to CROs. The CRO market is estimated to account for $24 billion in 2010. Over 50% growth to 2015 seen in global clinical trials market.
Estimated CRO total market revenues 2000-2010
Source: Business Insights, The CRO Market Outlook, Emerging markets, leading players and future trends, 2008.
Indispensible Role of CROs in Pakistan
Pharmaceutical companies are under pressure to bring more new drugs to the market while at the same time they have to cut their R&D budgets. As a result, companies are increasingly outsourcing their R&D to Contract Research Organizations (CROs), which offer services that can increase R&D effectiveness and at lower costs. Currently, about half of the clinical trial activities are outsourced to CROs.
Even though not a regulatory mandate as in other countries, it behooves a country like Pakistan with 600+ registered pharmaceutical companies to conduct bioequivalence, non-inferiority studies and conduct post-marketing surveillance studies on drugs marketed in Pakistan to prove efficacy and safety of drugs in the Pakistani gene pool – Pakistan patient population comes 1 .
A country like Pakistan can be popular just as India and China for its fast recruitment of trial participants, presence of broad spectrum of diseases, availability of human resources and technical skills, differing ethnic responses to drugs, and availability of “treatment naïve
population” when considering Pakistani clinical investigators participating in global studies. There are some active CROs in Pakistan with Metrics Research being the pioneer CRO and Site Management Organization (SMO) of Pakistan with global clinical trial and bioequivalence study experience followed by others such as Aklima, PPS, Crestar, SGS, Universal, Dimension, Rx and ProLynx Clinical (country’s first medical communications company (MCC) and CRO).
Taking cues from the western model, Pakistani businesses such as pharmaceutical companies, private and public institutions and hospitals can benefit significantly from this CRO-Sponsor
partnership paradigm which translates to value addition, efficiency and cost savings while assuring quality, data integrity and patient safety.
1. http://www.cipher-sys.com/Global%20Contract%20Research%20Organizations.pdf, 2008.
2. http://www.evotec.com/uploads/cms_article/192/Evotec_Initial_coverage_2010-07- 30.pdf
3. Tufts Center for the Study of Drug Development “Tufts CSDD Outlook 2010”http //csdd tufts edu/_documents/www/Outlook2010 pdf (accessed 30 December 2010).
4. Visiongain report, Pharma Clinical Trial Services: World Market 2011-2021