Whether formally accrediting IRBs will benefit research subjectsor simply create more paperworkremains to be seen.


Just as there is no one perfect way to train for a marathon, neither is there one perfect way to run an institutional review board or ethics committee that oversees the rights and welfare of volunteer research participants. Runners preparing for a marathon may consult various books and Web sites to get help toward achieving their marathon goals. IRBs in the United States consult the 

 on Protection of Human Subjects (21 CFR 50), Institutional Review Boards (21 CFR 56), and the Common Rule (codified at 45 CFR 46).

 Although these regulations set the foundation for protecting subjects, they do not address particular study designs, drugs, or devices to be studied or the attitudes in a given community.

New directions in human subjects protection include a call for voluntary 

 of IRBs. Why accreditation? Each IRB is located in a community that has its own attitudes and perceptions and a state (and/or nation) that has its own regulations. On top of this, each IRB reviews different types and volumes of research that pose varying degrees of risk to research subjects. Hence, effectively overseeing the rights and welfare of research subjects shares a characteristic common to reaching a marathon runners goal. Although there are many ways of going about the task, ultimately the goals are the same: for the runner, making it 26.2 miles; for the IRB, ensuring that each research participant is effectively protected.

This level of diversity requires a set of standards that allows each IRB to individualize to its specific environment, while adhering to regulations and maximizing oversight of research volunteers. This is what accreditation sets out to do, and it is a commendable objective. But some controversy surrounds proposed standards, with some of those involved asking whether increased regulation of IRBs will cause them to worry more about paperwork than about the rights and welfare of human subjects.This article summarizes the events that led to the current move toward accreditation and discusses the standards being developed by two organizations seeking to accredit IRBs. Our critique of those standards is designed to help you decide whether accreditation will simply add another layer of bureaucracy to IRB responsibilitiesor whether it will enhance the beneficence experienced by research participants.


In June 1998, the Office of the Inspector General published a report titled IRBs: A Time for Reform.

 This report outlines several obstacles to effective IRB functioning.

	They must review too many protocols, too quickly, with too little expertise.

	The continued growth of industry-sponsored studies puts an increased burden on IRB review and oversight.

	They conduct only minimal continuing review of investigations.

	Conflicts of interest are developing that can threaten IRB independence.

	IRBs are failing to evaluate their own performance and effectiveness.

On 2 June 2001, the death of Ellen Roche at Johns Hopkins sparked an immediate suspension of all research activities at the institution and prompted the Office for Human Research Protections (OHRP) to issue statements questioning the adequacy of oversight by the investigator and the IRB.

In response to a request from the Secretary of Health and Human Services, the Institute of Medicine formed a Committee on Assessing the System for Protecting Human Research Subjects to determine how to improve human subjects protection in clinical research. The committee conducted a two-phase study, and has released the first phase of its findings in a report titled Preserving Public Trust: Accreditation and Human Research Participant Programs (HRPP).

	Review proposed standards for accreditation of programs.

	Further develop accreditation standards.

The second phase of the IOMs work will focus on how to make accreditation work for the industry.

But is accreditation the answer? In a statement to CenterWatch, the president of an independent review board said, Some people say that some of the things theyre suggesting for accreditation may fall under policing.

 After examining the organizations that are piloting accreditation programs, we attempt to discern whether these standards will only add to institutional bureaucracy or truly enhance the protections that participants deserve when consenting to research participation. 


Websters defines accreditation as to make authoritative, creditable, or reputable.

 That is the basic premise for accrediting IRBs. Before we proceed, it is important to note that broad accreditation standards are being written to apply to all human research protection programs (HRPP) for the global research communitywhich includes sponsors, investigators, and IRBs. Here, we address accreditation standards as they pertain specifically to IRBs, not to the broad HRPP community. Two bodies have developed accreditation standardsthe National Committee for Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP). 

National Committee for Quality Assurance.

 In the spring of 2000, the Department of Veterans Affairs (VA) contracted with NCQA to develop an accreditation program for VA medical centers. The pilot phase of the VA accreditation program is complete. Data gathered from that program is being used to develop more broad-based accreditation standards that will apply to HRPPs. According to the IOM report, the NCQA standards are the strongest basis for accreditation of other research institutions, such as academic medical centers (AMCs), independent IRBs, and other research institutions. The purpose of the VA Human Research Protection Accreditation Program is to provide independent validation that HRPPs are in place, functioning properly, and effectively protecting human subjects.

 Of special note, according to Sandra Sanford, RN, MSN, CCRC, CIP, of the NCQA, 

NCQA is in the process of developing an accreditation program for Human Research Protection Programs (HRPP) outside the VA system. The new HRPP will utilize the current VA HRPP standards as a basis and will incorporate the recommendations of the IOM. The program will be composed of two modulesHRPP accreditation designed for academic institutions and other large research programs and IRB accreditation designed for independent IRBs and smaller programs without formal human research protection programs.

The NCQA HRPP Accreditation will begin pilot surveys in spring 2002. Because the current VA HRPP standards are specifically composed for VA institutions, further analysis will be needed when NCQA posts interim standards for the new HRPP Accreditation. 

The Association for the Accreditation of Human Research Protection Programs

 is the other accrediting organization. The AAHRPP interim standards, published September 2001, are the culmination of years of effort, which began under the guidance of Public Responsibility in Medicine and Research (PRIM&R) and an IOM grant.

 Because the AAHRPP interim standards are geared toward the broad research spectrum, not specific VA institutions, we review them in greater detail. 

The main purpose of the interim standards is to improve the systems that protect the rights and welfare of individuals who participate in research. This is a noble goal, but how does AAHRPP intend to establish criteria to accomplish the feat? The Guiding Principles box summarizes nine principles the organization developed to help guide the accreditation standards.

The model underlying AAHRPPs approach to accreditation lists five different structural domains of a highly developed human research program. These domains refer to the areas of responsibility that an HRPP must address:

 is the entity responsible for the human research program and the one that applies for accreditation. This may be a university, hospital, an independent IRB, contract research organization (CRO), or a biopharmaceutical company. In short, it is the entity seeking accreditation and wishing to help protect the rights and welfare of research subjects. 

 is part of the HRPP, and its primary responsibility is to protect the rights and welfare of human research participants. The organization must have mechanisms to ensure that the IRB has independent decision-making power. Whatever the arena of research, the IRB is the organizations safeguard, its agent to ensure the rights and welfare of research subjects.

 are those persons contracted by the organization to oversee or conduct the research according to the protocol in a specific location or facility. Investigators are the people who interact directly with research subjects. The organization has the responsibility to choose these important representatives of its research program and to ensure that they understand their responsibilities.

 is the entity that has a relationship with the organization, and funds the research. The sponsor may be the federal government, a pharmaceutical company, a university, or any other entity that finances the research study. Multiple sponsors may collaborate on a single research program. Whatever the case, it is the responsibility of the organization to identify all sponsors, and address all issues relevant to the human subjects participating in the research study. 

 are the human beings who participate as subjects under research protocols. The main goal of an HRPP in this domain is to enhance the involvement of research subjects at every stage of the research programand to ensure that the informed consent process helps to minimize risk to participants. 

The organization needs to be mindful off all aspects of subjects well-being, including their social, psychological, and physical needs. To do this, the organization has to give the rights and welfare of research subjects top priority by giving them access to all of the appropriate resources.

The AAHRPP believes there is no one right way to integrate the five domains into every HRPP, but that each entity seeking accreditation must demonstrate its own unique approach to meeting the 22 standards for the five domains. Each standard then has elements to help guide the organization toward compliance with the standard. The entity seeking accreditation (the organization) must meet all the requirements or, as the standards state, make arrangements with the other domains to obtain accreditation according to those standards. These arrangements make the organization seeking accreditation responsible for remaining independent from the other domains. This puts the organization in charge of its compliance, and allows it to make its own policies and procedures, in relation to the other domains, to protect subjects rights.

Those involved in clinical research need to ask themselves and their organizations two questions about accreditation. 

	Will it help protect the rights and welfare of the participant?

	Will it simply add more paperwork and bureaucracy to the organization with minimal or no impact on subject rights and welfare?

Below, we further examine two domainsIRBs and subjectsand critique scenarios for each set of standards. (The standards are subdivided into elements in the published interim accreditation standards and procedures document.) Thus we seek to determine whether meeting the standards will improve protection of the rights and welfare of research participants.

Articles

Feature Article

Whether formally accrediting IRBs will benefit research subjects?or simply create more paperwork?remains to be seen.

IRB Accreditation and Human Subject Protection

European Parliament debates on the allocation of research funds reveals Euro-MPs views of clinical research in medicines development.


There has been plenty of discussion of clinical trials in Europe over the last few weeks. Not so much in terms of the European Unions new clinical trials directive, which is gradually edging itself toward implementation, but in terms of European research.

The forum for most of this discussion has been the European Parliament, which held two major debates on the subject during Novemberone on the European Unions plans for a $15 billion research support program for the next six years, the other on how the EU should face up to the challenges of genetics. After a lengthy and complex debate on the research program in mid-November, the parliament gave the backing that is needed for the program to go aheadalthough it called for some significant changes, which will have an impact on clinical trials. And at the end of November, a heated debate on genetics produced some spectacular confrontations between the pro-science and anti-science lobbies, without arriving at any definitive conclusion, because the participants could not agree on a common view.

The nature of these debates is instructive about how Euro-MPs view research in general, and medical research in particular. Euro-MPs do not hold sole responsibility for European Union legislation (they are only one of the institutions involved in the creation of EU law through the Unions convoluted procedures), but their views are illustrative of many of the major currents of thought that underpin the evolution of EU rules. So this months column reviews some of the points made in the parliament about clinical trials, as a guide to how this institution sees the role of trials in medicines development.


The debate on the multiannual EU framework program 20022006 for research, technological development, and demonstration activities ranged widelybecause the program covers aviation and materials science as well as health. But most of the discussion was on how the funding to be made available for health should be allocated. The original idea, proposed by the European Commission, was to focus the resources entirely on genomics and biotechnology, so as to help the search for fundamental techniques that could be applied across a range of diseases. But the parliament insisted on making specific provision for major diseases too, so the parliaments final resolution split the health funding roughly in two, with half for genomics and biotechnology, and half for key diseases, such as cancer and diabetes. And much of the emphasis was on ensuring that the European-level possibilities for clinical trials are taken advantage of fully. The parliament specifies:

In these medical fields, the objective . . . will be to develop improved patient-oriented strategies for the prevention and management of disease and for living and ageing healthily. The research will therefore concentrate on translating the new knowledge being created by genomics and other fields of basic research into applications that improve clinical practice and public health.

And, according to the final vote in the parliament,

For cancer, the priority theme will sponsor a patient-oriented European Initiative on Cancer Research, containing three interlinked components: establishing a European Centre for the Exploitation of Research on Cancer, preferably by developing existing structures and networks, with the purpose of developing evidence-based guidelines for good clinical practice and improved public health strategies by accelerating the translation of existing research results into applications; supporting clinical research, particularly public-interest clinical trials, aimed at validating new and improved interventions; and supporting translationary research aimed at pulling basic knowledge through to applications in clinical practice and public health.

The justification for this modification to the Commissions proposal was that it was necessary to specify the contribution that can be made to cancer research at the European level.

 Tens of thousands of people die of cancer every year in the EU. Only if the Union succeeds in conducting more translational research, coordinated at EU level, will it be in a position to compete with the U.S. to keep top researchers in the EU. In addition, this will contribute to the development of medicines in this area in the EU. Improved coordination between the EU and the Member States will enable the overall budget for cancer research to be used more efficiently and will give a boost to the combating of cancer in the EU.

Another modification from the parliament insisted that provision should be made for 

Research linked to cancer, cardiovascular diseases, diabetes and diabetes-related diseases, degenerative diseases of the nervous system (including Alzheimers Disease, Parkinsons Disease and experimental treatments now under investigation for new variant Creutzfeldt-Jakob Disease), psychiatric diseases, cardiovascular diseases, viral hepatitis C, allergies and metabolism diseases including diabetes and rare diseases.

It called for transnational research and comparative studies and coordinated development of European databases to provide comprehensive pictures of the diseases; cooperation with and support for existing networks; interdisciplinary networks, to be set up preferably by linking existing networks; clinical cancer research; exchange of clinical practice; and clinical trials on new drugs. The justification, the parliament said, was self-explanatory.

Some of the references to clinical trials that occurred in the draft report were not included in the final version that the parliament adopted at the end of its debatebut again they offer an insight into some of the thinking conditioning the clinical trials world at the European level. Less attention can be paid to some of these proposalsfor instance one on Research on medical use of cannabis, which took account of the emerging interest in the medicinal use of cannabis, not only in the Netherlands . . . other EU governments are showing interest. The ill-fated draft amendment added that

on several occasions the International Narcotics Control Bureau called on the associated countries to stimulate clinical trials with cannabis. Although there are indications that cannabis could be useful in certain diseases, its therapeutic use is not evidence based. Historically over 40 indications have been reported. The most promising are multiple sclerosis, appetite stimulant in AIDS-wasting syndrome and cancer, nausea and vomiting in cancer chemotherapy, epilepsy, several forms of pain, and glaucoma.

But EU backing for such trials will have to wait for another day, it seems. 

However, another draft amendment shows a growing recognition among at least some Euro-MPs of the rigors of successfully conducting trials. It urged support for research which assists the battle against serious diseases, noting that priority should be assigned to research efforts which one member state alone cannot undertake or cannot undertake as efficiently as the European Union and which will directly benefit patients within the foreseeable future. The measures in this field would also support policy-orientated research, the report states. It continues, This would include, for example, research documenting trends in risk factors; research into the effectiveness of interventions to tackle inequalities in health; research into the reasons for survival differences in treatment outcomes; and health services research. The justification is that 

in a whole range of areas, e.g. combating rare diseases and the field of childrens diseases, it is often not possible for one member state alone to carry out the necessary research. Particularly in the case of clinical trials, large numbers of patients are needed. These can more readily be found on a European scale than if research is confined to a single member state.


The draft report on genetics noted a lack of coherence in EU rules governing research: There is a plethora of divergent, or at any rate not wholly consistent, national rules applying at every stage from development to the clinical trial, and that this is recognised to pose a severe limitation, making it difficult to develop and test new biomedicines on an EU-wide scale, although these are activities that should be encouraged. 

The report goes on to recommend as a first step, the EU directive on clinical trials should be transposed into national law as soon as possible. An explanatory statement annexed to the draft report says that the clinical trials directive, which lays down provisions for implementing good clinical practicedefined as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjectsconstitutes a first element of harmonised regulation of biomedical research and development.

But if the EU creates a framework in which the opportunities are exploited to the full, it said, EU citizens will be able to benefit from the significant health advantages of genetic research, and further investment will gravitate toward European science and the pharmaceutical industry, which are having to operate in an increasingly more competitive global context, it said.

At the heart of the debate on genetics was the tension between helping science move forward, on the one hand, and protecting human dignity on the other. What matters, said the draft report,  

is to weigh up the risk against the opportunities being opened up by science and to refrain from delaying the advent of useful technologies. Responsibility toward future generations applies not only to the responsibility for doing things, but also to the responsibility for not doing things that theoretically and in practice could be done. The debate on human genetics and its applications is taking shape haphazardly and often does not start until after a product has become available. We must take up the challenge of drawing up essential ethical guidelines, the substance of which should be such as to serve as a basis for general assessment of the development and use of human genetics and cover rules seeking to safeguard considerations such as: free and informed consent, assessment of risks in relation to benefits, protection of the health of persons involved in clinical trials, scientific assessment of stem cells for therapeutic uses, the anonymity of donors, management of stem cell banks and their confidentiality, a ban in trade in embryos, and import and export of stem cell products.

Part of the motivation for the draft report was the concern to preserve Europes innovative capacity in the field of genetics, because In Europe, according to a reliable prediction, the genetics sector will grow rapidly over the next 10 to 15 years and become part of conventional medical practice, playing an increasingly greater role in diagnoses and prognoses affecting a persons health. The acceptance of the role of clinical trials as an index of innovative capacity recurs throughout the report. It describes the European contribution to the genetics sector as very significant, both as regards the substantial fund of basic knowledge (30% of publications on gene therapy in the world in the year 2000 originated from the Union) and in terms of industrial competitiveness. The European industry involved in gene therapy is of comparable size to its American counterpart in terms of the number of small and medium-sized enterprises (26 in the Union and 24 in North America in 2000) and large drugs companies (9 in the EU and 11 in the US) but appears to be lagging a little behind as regards the number of employees, the number of sponsored clinical trials, and the number of companies quoted on the Stock Exchange (4 as opposed to 8).

The sector has grown spectacularly in the last three and a half years, the report said, noting that attention should be drawn in particular to the increase in the number of clinical trials, companies which organise trials, and joint projects between companies, since this is a clear sign of the sectors maturity.

Nevertheless, it notes with concern, the North American industry is still stronger and more advanced. This finding is true whether the yardstick applied is the number of employees, the number of companies quoted on the Stock Exchange, the number of companies which organise clinical trials, or the number of or amounts of money involved in joint projects. And this applies in particular, it says, to product development in collaboration with certain US companies which organise the clinical trials at the final stages. In Europe only Transgene is in a position to do likewise.

It is a measure of the growing maturity of the clinical trials sector in Europeand of the growing maturity of the European Union institutions in relation to medicinesthat clinical trials received this much attention in these debates. It was not many years ago that the European Parliament, and indeed the European Union institutions on the whole, were largely ignorant of what clinical trials were, and would have been incapable of articulating a single coherent observation on their role and significance. This more informed parliament does not guarantee that all questions relating to clinical trials will always obtain fully informed discussionbut it does suggest that in the battle for understanding, the European drug industry and research community has made some headway in raising awareness of what is at stake.            

View from Brussels

Europe Looks at Trials in Future Research

Efforts to ensure the safety and integrity of clinical trials will generate new standards and expand oversight initiatives. 


For the past year, government officials have been trying to remodel the system for protecting human research participants. Situations that led to the death or injury of study subjects prompted government regulators to shut down research at eminent academic institutions and to call for major changes in institutional review board (IRB) operations. Now the national campaign to counter bioterrorism is encouraging the development of critical therapies to protect against germ warfare or infectious diseases. The government is negotiating with manufacturers to provide drugs and vaccines to federal and state agencies, and regulators are evaluating policies that may help speed new therapies to patients. 

These trends may generate some tension between maintaining safeguards for clinical study subjects and accelerating the overall research process. Some ethicists are concerned that antibioterrorism efforts may encourage researchers and regulators to ignore safety and privacy issues. The Food and Drug Administration will play a central role in monitoring activities involved with testing and producing new vaccines for smallpox and anthrax, and it does not want to appear as a roadblock to development of needed treatments. At the same time, The last thing we want to do is approve a vaccine from a new source that is not safe or effective, said FDAs top deputy commissioner Bernard Schwetz at a meeting of the agencys Science Board in November. FDA is working to define those circumstances where the agency may permit the use of unapproved drugs in emergency situations. A related task is to clarify agency policy for when data from animal tests or surrogate markers can supplant or replace the clinical evidence usually required to approve a new therapy.


FDA and the Office of Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) have been expanding and solidifying programs to strengthen human subject protections. These efforts will continue in the year ahead. Traditionally, the main objective of FDAs bioresearch monitoring (BIMO) program has been to maintain the integrity of clinical data submitted in market applications. In recent years, the agency has increased oversight to focus more on ensuring the safety and protection of study participants. According to David Lepay (FDA senior advisor for clinical science), one reason for this development is an increase in problems and rule violations among clinical investigators. He attributes this development to the overall expansion of clinical studies and investigations; increased study enrollment of vulnerable populations, such as children and the elderly; testing of more innovative technologies; and expansion of clinical research in nations that lack strong rules governing biomedical research. 

Lepay heads FDAs relatively new Office for Good Clinical Practice (OGCP) in the commissioners office. OGCP was established to coordinate GCP policy and bioresearch monitoring programs across agency centers. It also serves as a liaison with OHRP and other government agencies involved with human research subject protection. OGCP will benefit from added resources provided in FDAs budget for 2002, which gives the agency $10 million to monitor clinical trials. This is expected to permit FDA to increase by one-third the 1,000 or so inspections it does each year related to clinical research. While investigators will continue to follow up on complaints, the agency also plans to conduct more state of the field inspections for gene therapy trials and pediatric studies.

Added funding will help FDA and OHRP pursue a number of initiatives in the coming year:

 FDA is working with OHRP to establish an IRB registration program that will provide a more accurate picture of the scope of these oversight boards and their capabilities. Research institutions that receive government funding now have to register their IRBs as part of the federal assurance process, and FDA is looking to create a similar system for the IRBs it oversees. Also in the works is a voluntary accreditation program for IRBs that aims to better define and clarify IRB functions and responsibilities in order to reduce redundancies. 

 FDA is revising rules to provide additional safeguards for children participating in clinical trials and is looking at new policies involving pregnant women, human fetuses, neonates, and other vulnerable populations. 

Expand use of data monitoring committees.

 FDA issued a draft guidance on DMCs in November, followed by a meeting to stimulate the research community to read and comment on the proposal by February. FDA officials regard DMCs as useful for improving oversight of any high-risk or innovative trial and for helping sponsors decide when to revise protocols or to end a study early. FDA hopes to issue a final guidance by year-end.

Increase review of academic research institutions.

 OHRP has launched an ambitious program to conduct quality improvement evaluations at every major medical school and research organization in the United States. These are based on a self-evaluation process that may or may not lead to site visits. 

 FDA continues to implement its policy for reporting investigator financial conflicts of interest (COI) while also examining other potential conflicts arising from compensation to subjects, controls on the publication of study results, and efforts to exert pressure on IRBs. In addition, OHRP is developing guidance to minimize and manage COI at academic research institutions, which have been fairly critical of the proposal. OHRP director Greg Koski is making changes and hopes to issue a final version this year. 

 A report from the HHS Office of the Inspector General (OIG) released in September indicates that overseas researchers registered with FDA have increased from 271 in 1990 to more than 4,400 in 1999. Moreover, about 25% of new drug applications contain non-U.S. studies with data important to approval decisions. Because FDA lacks the resources to monitor most foreign studies, the agency is encouraging worldwide adoption of harmonized good clinical practices (GCPs) through the International Conference on Harmonisation (ICH). The OIG also calls for FDA to help train foreign ethics boards and to seek voluntary compliance with U.S. research standards by foreign investigators. 


A major challenge for FDA and sponsors this year will be to agree on policies for reauthorization of the Prescription Drug User Fee Act (PDUFA), which expires in September. There is broad interest in continuing the user fee program, but FDA and manufacturers have different proposals for revising this program that supports the development, testing, and approval of new drugs and biologics. 

The agency wants to boost current fee revenues, which it claims are too low to cover the many tracking and performance requirements of the current program. FDA also wants fee revenues to be available to support the review of investigational therapies, of fast track programs, and of postapproval monitoring. Pharmaceutical companies, however, want to retain performance standards so that FDA will be accountable for meeting certain timeframes related to product development and application review. The agency formally kicked off the negotiating process at a PDUFA public meeting in December. The debate promises to be heated, but the general success of the program over the past 10 years makes compromise likely before the renewal deadline.

The need to reauthorize PDUFA this year may provide an opportunity to review a number of FDA policies, as occurred five years ago when Congress enacted the FDA Modernization Act (FDAMA). Any FDAMA revision is expected to be more modest than the 1997 bill, although some modernization initiatives are likely to surface. These may address international standards, postapproval safety monitoring, clinical research safeguards, and measures to enhance FDA management of counter-bioterrorism programs. 


Publication of the human genome more than a year ago has generated promises of a new age of biomedical discovery, as scientists expand their understanding of the causes of human disease and of issues related to pharmaceutical innovation. At the same time, policy makers are concerned about how individual genomic information may violate personal privacy standards. There also is heated debate over the ethical implications of research using embryonic stem cells and research likely to lead to cloning of a human being. 

Last summer, the Bush administration sought to resolve the stem-cell research controversy by adopting a compromise policy. It permits the federal government to support R&D using existing embryo banks but with limits to appease those who consider it unethical to pursue any activity that results in the destruction of human embryos. Congress halted efforts to regulate this area to see how the Bush policy may affect cutting-edge research. However, the legislators revived calls for a total ban on cloning when a private company announced in November that it had succeeded in creating human embryos through cloning. 

These issues will be examined further by the new White House Council on Bioethics, which will advise Bush on policies related to biomedical science and technology. The panel also may review ways to protect human research subjects and the consequences of limiting scientific investigation. Scientists and sponsors will be interested in how these deliberations shape ethical guidelines for new biomedical investigation and discovery.


The debate over user fees this year will touch on how much FDA regulation contributes to the increasingly high cost of testing and bringing new drugs to market. Adding fuel to the fire is a new industry-backed study that puts the cost of developing a new prescription medicine now at $802 million. Over the past 15 years, R&D costs have risen much faster than inflation. According to the Tufts Center for the Study of Drug Development, the increase is largely due to soaring clinical trial expenditures. That trend reflects increased difficulty in recruiting subjects, expanded focus on drugs to treat chronic and degenerative diseases. Tufts acknowledges that its new estimate includes the cost of research failures and of capital, but industry critics charge that the study is biased and that it demon            

View from Washington

Efforts to ensure the safety and integrity of clinical trials will generate new standards and expand oversight initiatives.

Clinical Research to Remain in the Spotlight This Year

Addressing the unnacceptable lack of pediatric labeling requires not only economic incentives but also an understanding of the unique difficulties involved in pediatric studies.

Applied Clinical Trials-01-01-2002

IRB Accreditation and Human Subject Protection

Europe Looks at Trials in Future Research

Clinical Research to Remain in the Spotlight This Year

Authorities Recognize a Need to Encourage Pediatric Drug Development