Patient Access To Investigational Products

A common method for patients to access investigational products is to enroll in a clinical study. Sponsors with open protocols are required to list their studies based on the Food and Drug Administration Modernization Act (Public Law 105-115 Section 112 Subsection (d)) within 21 days after the protocol goes into effect on a Federal web site known as Clinicaltrials.gov. Section 113 of the Food and Drug Modernization Act requires you to submit information to the data bank about a clinical trial...

Unique Ethical And Legal Considerations

In addition to these general ethical and legal principles that are faced by all researchers involved in research involving human participants, the physician investigator involved in cancer clinical trials must also consider the unique ethical issues that arise in a setting in which the research participants are patients suffering from a disease for which the standard treatment available is not suitable to either effectively treat the patient's condition or to improve the patient's quality of...

Background

In 1989, the National Institutes of Health (NIH) created the Office of Scientific Integrity (OSI), in response to Congressional concerns about public reports of fraud in biomedical and clinical research supported by NIH at major universities and research hospitals. Simultaneously, the Department of Health and Human Services (HHS) issued regulations for research institutions to deal with allegations of scientific misconduct (42 Code of Federal Regulations, Part 50, Subpart A). These regulations...

Conclusion

This chapter stresses the importance of integrity in cancer clinical trials and provides examples of cases of research misconduct, handled by the Office of Research Integrity and its predecessor, the Office of Scientific Integrity, for the National Institutes of Health and the Department of Health and Human Services, in which clinical research coordinators, research nurses, and physicians did not maintain high standards of integrity in their research records. Table. ORI findings of scientific...

Principles That Apply To Biologics

Government protection of the public health in the United States dates back to the 18th century. In 1785 the State of Massachusetts passed a law prohibiting the sale of diseased, corrupted, contagious or unwholesome provisions if known to the seller, but not the buyer, with the punishment to be inflicted according to the degree and aggravation of the offence. Punishments included fines, imprisonment or use of the pillory. In 1813 the United States Federal government passed the Vaccine Act which...

The IND Review Process

Upon receipt of an IND application, the FDA will issue an Acknowledgement Letter that informs the sponsor of the IND number and outlines general procedures. Unless the sponsor is contacted and informed of deficiencies, an IND is considered in effect 30 days after the IND application has been received by the FDA. The FDA has teams of technical experts that are assigned to each IND submission. In general, the primary review disciplines are product, pharmacology toxicology, clinical and...

Cancer Conferences

Recognizing that cancer is a complex group of diseases, the CoC Cancer Program Standards (2.6 through 2.9) promote consultation among surgeons, medical and radiation oncologists, diagnostic radiologists, pathologists, and other cancer specialists. This multidisciplinary cooperation results in improved patient care. Cancer conferences are an essential forum to provide multidisciplinary consultative, services to cancer patients, encourage multidisciplinary involvement prospectively, and are...

Assessments and findings of an audit

During an audit, evaluations of each of the three key components (i.e. the IRB and informed consent, the pharmacy and the patient cases) are conducted independently of each other. Each component is assessed and rated as either Acceptable, Acceptable needing follow-up, or Unacceptable. While these ratings are difficult to define precisely, the CTMB has established a set of major or lesser deficiencies that is used commonly by all cooperative groups. A complete set of ratings as defined by the...

Edited by

Professor and Director of Sentinel Lymph Node Program University of California San Francisco Medical Center at Mount Zion San Francisco, CA, USA Stanley P. L. Leong Department of Surgery University of California Medical Center at Mount Zion 1600 Divisadero Street San Francisco, CA 94143 leongs surgery, ucsf.edu CANCER CLINICAL TRIALS PROACTIVE STRATEGIES Library of Congress Control Number 2006927192 ISBN-10 0-387-33224-3 e-ISBN-10 0-387-33225-1 ISBN-13 978-0387-33224-6 e-ISBN-13...

Privacy Rule And The Common Rule

As described above (Review Preparatory to Research), DHHS has provided guidance that it considers research to be occurring if the investigator records PHI or other identifiable private information during the search for potential subjects (during the ascertainment recruitment process). The investigator must therefore first obtain IRB approval of the research, and then obtain either consent and authorization of the subjects or IRB + -Privacy Board approval of a waiver of consent and authorization...

References

Keating P, Cambrosio A From screening to clinical research the cure of leukemia and the early development of the cooperative oncology groups, 1955-1966. Bull Hist Med 76 299334, 2002 2. Kelahan AM, Catalano R The history, structure, and achievements of the cancer cooperative groups. Managed Care & Cancer 28-33, 2001 3. NCI's Clinical Trials Cooperative Group Program 4. National Cancer Institute FY 2004 NCI Fact Book 6. Lukens JN Progress resulting from clinical trials. Solid tumors in...

How To Turn Challenges Into Userfriendly Strategies

The PI must be familiar with all of the issues and challenges presented in this chapter. After a thorough review of these issues, the hope is that the PI will develop a strategy and infrastructure to deal with these challenges, while remembering that it is noble to conduct cancer clinical trials in order to help cancer patients. Pis should constantly remind themselves of the characteristics they should possess if they wish to be involved with clinical trials (Table 3). These personal values are...