Essential Role of Contract Research Organization (CROs) in Pakistan. (2024)

Byline: Faisal H Roohi

Pakistan is an emergent market economy with excellent prospectsbeckoning at its doorstep. Clinical research is one that has now enteredmost of South and SE Asia save some unfortunate countries hamstrung bypoor governance or absorbed in political imbroglios with Pakistanheading this list. Despite an incredible talent pool in the health andlife sciences sector among others that are making headlines forthemselves and native country in the developed world, life for thoseleft behind is humdrum to put it mildly.

We can attribute several reasons for this dilemma such as thosenoted in the first paragraph, others being economic mismanagement, poorplanning, lack of foresight, lagging health regulations and educationalinfrastructure, lack of investment in human resource development, plusseveral others.

Most research is indigenous being conducted at health, private andpublic institutions without proper governmental financial support orvigilance which in itself tells volumes about our people's ambitionand of their unique achievements. Some local and MNC pharmaceuticalcompanies are also conducting research studies or participating inglobal studies which arev laudable and encouraging.

What is a Contract Research Organization (CRO)?

A CRO can be described as an organization/person that is contractedby a sponsor to manage various steps in the drug development process,including conduct of preclinical studies, clinical study design andexecution, data management, analysis, medical writing, and regulatorysubmission.

Services provided by a CRO: The types of services may be one ormany or full-service provider CROs may offer an exhaustive list of coreand ancillary R and D services. Listed below are services that from apractical 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)

Types of Relationships

* Preferred Vendors: Sponsor directs business to selectedshort-listed CROs

* Functional Service Providers (FSPs): Sponsor selects CROs onbasis of specific capabilities

* Risk sharing: CRO shares risk and reward with Sponsor onproject-by-project basis

* Technology Partnership: CRO offer third-party developedtechnology to clients

* Drug licensing: CRO conducts drug research for its own products

Outsourcing Model: The phenomenon of outsourcing became popularmore so in the 90's and is continuing to date. This enables CROsprovides their specialized services on a for fee for service basis basedon the afore-mentioned relationships.

Definition: "The strategic use of outside resources to performactivities traditionally handled by

Internal staff and resources".

It is a trend for pharmaceutical companies to contract thirdparties to conduct their clinical trials in order to test their drugs.This trend is referred to as 'outsourcing', and the companiesthat carry out the work are called 'contract researchorganizations' (CROs). In addition, clinical trials areincreasingly conducted in non-traditional trial regions, which aremainly low- and middleincome countries.

Why Outsource?: There are several reasons and mostly it is due toprevalent global economic recession and down-sizing all revolving aroundseeking avenues of revenue generation and optimization. Other reasonsare as follows:

* Lack of internal capacity / expertise

* Strategy / policy to outsource certain programs

* Focus on operations

* Cost savings

* Allow sponsor to focus on its core competencies

The CRO Advantage: CROs bring with them a wealth of experience ofworking with many different products, regulatory regions, organizationsand quality systems, which allows them to quickly integrate into theoperations of the sponsor organization. It allows the sponsor to quicklytake advantage of different markets and opportunities due the immediateavailability of expert personnel, knowledge and equipment. This avoidsthe need for the sponsor to invest in capital equipment or hirespecialist staff. The costs of projects are agreed in advance, thereforethe cost of development is defined at the outset and the cost of aproject can be directly controlled. These relationships also allow acompany to expand into, or take advantage of, technologies that are notit* traditional expertise.

Disadvantages: CROs being businesses themselves may penalizesponsors in the event of unforeseen circ*mstances such as earlytermination of projects, delays or additional requirements (translatinginto additional costs). However, if a sponsor can manage a project in amanner that results in minimization of long term R and D expenses whilecontaining short-term costs, they will obtain a net advantage in hiringon services of a CRO.

CROs Worldwide Presence: The CRO sector is highly fragmented withover 1,100 CROs worldwide, although more than two thirds of all CROs arebased in the US. CROs come in many shapes and sizes: some arespecialized in certain services in certain areas (the small specialtyCROs), and some offer the whole spectrum of services in a drugdevelopment process around the world. This latter group comprises theglobal full service CROs, which have a presence in all emerging markets.Of the major global CROs, Quintiles is the market leader, with 14% ofthe global market share; followed by Covance and Pharmaceutical ProductDevelopment (PPD), which hold 10% each of the market share (see Tablebelow). The five largest CROs hold 45% of the total market between them.

Nearly 70% of the total research and development (R and D) costsare spent on clinical trials. Clinical trials are a key factor in therising R and D costs because today's drug trials are larger andmore complicated on average and require more participants than everbefore. In addition, recruiting participants is becoming more difficultin western countries. In 2008, US Pharma companies spent $32.2 billionon trials. Pharmaceutical companies are under pressure to bring more newdrugs to the market while at the same time they have to cut their R andD budgets. As a result, companies are increasingly outsourcing their Rand D to Contract Research Organizations (CROs), which offer servicesthat can increase R and D effectiveness and at lower costs. Currently,about half of the clinical trial activities are outsourced to CROs. TheCRO market is estimated to account for $24 billion in 2010.Over 50%growth to 2015 seen in global clinical trials market.

Indispensible Role of CROs in Pakistan

Pharmaceutical companies are under pressure to bring more new drugsto the market while at the same time they have to cut their R and Dbudgets. As a result, companies are increasingly outsourcing their R andD to Contract Research Organizations (CROs), which offer services thatcan increase R and D effectiveness and at lower costs. Currently, abouthalf of the clinical trial activities are outsourced to CROs.

Even though not a regulatory mandate as in other countries, itbehooves a country like Pakistan with 600+ registered pharmaceuticalcompanies to conduct bioequivalence, non-inferiority studies and conductpost-marketing surveillance studies on drugs marketed in Pakistan toprove efficacy and safety of drugs in the Pakistani gene pool - Pakistanpatient population comes 1st.

A country like Pakistan can be popular just as India and China forits fast recruitment of trial participants, presence of broad spectrumof diseases, availability of human resources and technical skills,differing ethnic responses to drugs, and availability of "treatmentnaive population" when considering Pakistani clinical investigatorsparticipating in global studies.

There are some active CROs in Pakistan with Metrics Research beingthe pioneer CRO and Site Management Organization (SMO) of Pakistan withglobal clinical trial and bioequivalence study experience followed byothers such as Aklima, PPS, Crestar, SGS, Universal, Dimension, RxandProLynx Clinical (country's first medical communications company(MCC) and CRO).

Conclusion

Taking cues from the western model, Pakistani businesses such aspharmaceutical companies, private and public institutions and hospitalscan benefit significantly from this CRO-Sponsor partnership paradigmwhich translates to value addition, efficiency and cost savings whileassuring quality, data integrity and patient safety.

References

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 CSDDOutlook 2010".http://csdd.tufts.edu/_documents/www/Outlook2010.pdf(accessed 30 December 2010).

4. Visiongain report, Pharma Clinical Trial Services: World Market2011-2021