Globalization White Paper





 
The CRO Market

CROs – Experts in Clinical Research

For more than 25 years, clinical research organizations (CROs) have specialized in the high-quality conduct of clinical studies primarily on behalf of pharmaceutical, biotechnology and medical device companies.

CROs have become a cornerstone of research enterprise, adhering to the highest standards of scientific quality and medical ethics. The industry has evolved from providing primarily preclinical services or single- service support in clinical monitoring and data management to a full-service industry offering services from the earliest stages of development through clinical trials and commercialization of products.

Today CROs constitute about half of the research workforce involved in drug and medical product development. They provide a wide range of clinical development services to research sponsors, including consultation with study design, investigator recruitment, study monitoring, and data analysis.

As experts in the clinical research process, CROs comply with rigorous U.S. and international regulations and Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards. For CROs who are members of ACRO, this begins with the association’s Code of Ethics, which emphasizes the rights and safety of study participants and the CRO industry's support for laws and regulations that enhance them.

ACRO is committed to demonstrating the strategic value of clinical outsourcing and the important contribution CROs make as partners in the development of new medicines and new treatments.

Clinical Research by the Numbers:

CRO Expertise and the Clinical Research Enterprise

  • ACRO member companies are leading clinical research organizations (CROs) that provide a full range of clinical development services and conduct research in over 80 countries. Our members employ more than 40,000 professionals and generate more than an estimated 70% of industry revenues worldwide. (Source: ACRO member data)

  • Approximately 80,000 clinical trials are conducted in the U.S. each year sponsored by both industry and government. These studies to advance medical science require the work of an estimated 200,000 research professionals and the involvement of millions of study participants each year. (Source: CenterWatch)

  • CROs have a significant role in the clinical research enterprise. In 2004, ACRO’s members enrolled more than 640,000 participants in clinical studies and managed nearly 23,000 Phase I-IV studies at 152,000 clinical sites worldwide. (Source: Tufts CSDD)

  • Research sponsors commonly partner with CROs to take advantage of their clinical research expertise, skilled workforce and resources to help accelerate the development of treatments for the cure and prevention of disease. Today, biopharmaceutical companies outsource approximately 25% of all clinical trials. Industry analysts expect this figure to increase to 35% over the next five years. (Sources: Frost and Sullivan, ACRO member data)

  • Industry analysts estimate the worldwide CRO market was $17.8 billion in 2007, and predict demand for CRO services will continue to grow at a rate of 15% annually. (Sources: Goldman Sachs; Frost & Sullivan)

  • In 2006, CenterWatch reported that of phase I-III trials not conducted in-house by research sponsors, CROs are involved in about 74%. The increasing involvement of CROs has allowed the biopharmaceutical and medical device industries to expand the number of research development projects they conduct, complete many of them more quickly, and do so while maintaining comparable data quality. (Source: Center Watch)

The Drug Development Process

  • In 2006, the Tufts Center for the Study of Drug Development found that research development projects in which CROs are greatly involved are submitted to the FDA more than 30 days closer to the projected submission date than projects with less CRO involvement. This ability to reduce project timelines while maintaining a level of quality comparable to that of research sponsors is just one of the ways CROs improve efficiencies in drug development. (Source: Tufts CSDD)

  • The drug discovery and development process is extremely lengthy and expensive. In 2001, the Tufts Center for the Study of Drug Development estimated the cost of developing a new drug to be $802 million. It takes an estimated 15 years to bring a single new medical treatment from the discovery stage in the laboratory to the pharmacy shelf. This time from synthesis of the molecule to marketing approval has more than doubled since 1964, from 6.5 years to 15 years. (Sources: Hoover Institution, Tufts CSDD)

  • Clinical trials are one of the most important parts of the drug development process. They also one of the most time-consuming. Between 1999-2002 and 2003-2006, the length of the average clinical trial – from protocol design readiness to database lock – increased by nearly 70%, from 460 to 780 days. (Source: Tufts CSDD)

  • The complexity of conducting clinical studies has grown considerably over the past 30 years. From the 1980s to the 1990s, the average number of clinical trials conducted before marketing approval for a new drug more than doubled, increasing from 30 trials to nearly 70. The average number of participants needed for each clinical study also grown substantially in the last 3 decades – from an average of 1,700 to 4,300 volunteers. (Sources: CISCRP, Hoover Institution, U.S. FDA)

  • In another example of the increasing complexity of clinical research, there has been a steady increase in the number of clinical procedures needed for each clinical trial. In 2005, 72% of U.S. clinical studies involved more than 85 procedures, an increase of 70% over 2000. (Sources: Accenture, PhRMA)

  • For every 5,000 to 10,000 potential drug candidates that enter the discovery research stage, only about 2.5 to 5% will make it through to the preclinical phase. Of that percentage, only 0.05 to 0.1% will enter the clinical trial testing phase. The result of those 5,000 to 10,000 candidates is just one regulatory-approved drug to market. (Sources: PhRMA, Tufts CSDD)

The Essential Contribution of Clinical Study Participants

  • Clinical study participants are the unsung heroes who help to bring critical new treatments to the patients who need them. An overwhelming majority of people (77%), say that they would consider participating in an appropriate clinical study if asked. However, only 10% of those eligible to participate in clinical trials do so in the U.S. (Sources: CISCRP, Harris Interactive)

  • In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process. (Sources: CISCRP, CenterWatch)

  • A 2007 survey determined that 91% of study volunteers interviewed would participate in a clinical trial again, and 85% said they would recommend a family member or friend volunteer in a study. (Source: CenterWatch)

  • ACRO is committed to working with stakeholders from across the research enterprise to improve public education on the importance of clinical research and the vital role study participants play in furthering scientific discovery.

 

 

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