Cancer and Leukemia Group B - Function

Function

CALGB Research Objectives

• To answer important therapeutic questions through large clinical trials
• To develop a strong multidisciplinary approach to cancer treatment and prevention
• To integrate information obtained from basic science and from economic and psychosocial investigations with information from clinical trials
• To explore the relationship between dose density and therapeutic outcome
• To systematically explore methods of optimizing treatment for individual patients
• To introduce novel therapies and treatment approaches for patients with poor prognoses
• To study quality of life and impact of cost on cancer patients
• To encourage fresh and innovative ideas of new investigators
• To involve community hospitals in CALGB cancer research
• To maintain a high degree of quality control in all CALGB science
• To increase participation of minority populations, the elderly and women in clinical trials
• To collect, analyze, and publish the results of CALGB studies

Multimodality Studies of Adult Solid Tumors

The number of CALGB protocols involving multimodality treatment has increased steadily over the years. Areas of particular interest within CALGB are the role of minimally invasive surgery in patients receiving state-of-the-art multimodality therapy as well as neoadjuvant therapy prior to surgery.

Correlative Sciences

During the 1970s, the CALGB initiated the application of immunologic methods for the study of leukemia and lymphoma. Continuing with progressively more sophisticated studies, interest has expanded to include the application of molecular-genetic techniques to characterize leukemias, lymphomas, and solid tumors at the gene level. This information is providing dramatic insights into relationships between gene mutation and treatment outcome and allowing better treatment selection for individual patients.

Pharmacology Studies

Pharmacokinetic data are important for determining the optimal dose or schedule of a drug. The Pharmacology & Experimental Therapeutics Committee has increasingly focused on pharmacogenetics, the study of how genetic variation may impact on the toxicity or efficacy of drug therapy.

Studies of New Agents

The CALGB has a long history of accomplishments in evaluating new therapeutic agents. The Group has developed innovative strategies for testing new agents while allowing patients to receive standard therapies.

Cancer Control and Health Outcomes

The CALGB has pioneered the use of telephone interviews for data collection concerning quality of life in cancer patients. Studies exploring the relationship between therapy and quality of life and the economic impact of new treatments are underway.

Cancer in the Elderly

CALGB has been among the leaders in designing studies specifically assess the pharmacology and tolerance of chemotherapy in older patients, barriers to treatment of older patients on clinical trials and therapeutic options for older women with early stage breast cancer.

Study Development and Monitoring

The concept for a new study originated by a CALGB member is discussed by the Disease Committee and Modality Committee core; it is then discussed by the full committee. The committee chairs bring the concept to the Executive Committee and, if approved, the Study Chair develops a draft protocol. The relevant Committee Chair, the responsible Statistician, appropriate chairs of other Disease and Modality committees, patient advocates, and the Principal Investigators at the main member institutions are involved in the protocol design. After CALGB review and NCI approval, the Central Office officially activates the protocol. A Data and Safety Monitoring Board (DSMB) periodically reviews interim reports prepared by the Statistical Center for all Phase III studies. When the required number of patients has been entered on a study, the study is closed. The DSMB may elect to terminate a protocol early or to continue a study beyond its intended accrual. Final analysis of the data is the responsibility of the Statistical Center and the Study Chair.

Study Analysis

The Statistical Center is responsible for all database management and statistical activities within the Group. Statisticians and Data Coordinators are members of all Disease and Modality committees. Each Group research study is assigned to a Statistician / Data Coordinator team, which actively collaborates in the design, implementation, interim and final analyses, and publication of Group research. Study Chairs are required to formally evaluate each patient record at key points in the patient's progress. Quality control checks are done on all data submission forms.

Data Management

The Clinical Research Associates promote efficient and accurate documentation and collection of data. Data audits are conducted on-site at the member institutions of the CALGB, along with their affiliates and CCOPs. These audits are performed to confirm the data reported on the clinical research forms.

Radiation Therapy Quality Assurance

The CALGB Radiation Oncology Quality Assurance Subcommittee reviews CALGB data under the auspices of the Quality Assurance Review Center (QARC) in Lincoln, Rhode Island. QARC was organized to monitor radiotherapy quality assurance programs for several cooperative groups and is supported independently of the CALGB. Today QARC provides radiotherapy quality assurance and diagnostic imaging data management to all of the National Cancer Institute (NCI) sponsored cooperative groups. These groups include CALGB, the Children's Oncology Group (COG), the Eastern Cooperative Oncology Group (ECOG), the Southwest Oncology Group (SWOG), and others. Although QARC is largely supported by grants from the NCI and NIH (National Institutes of Health), the center also contracts privately with the pharmaceutical industry so as to offer its services in clinical trials for anti-cancer drugs. Lastly, QARC maintains a strategic affiliation with the University of Massachusetts Medical School (UMMS) in Worcester, Massachusetts.

Institutional Performance Evaluation Committee

The Institutional Performance Evaluation Committee (IPEC) develops and implements standards of performance for the CALGB and reviews performance of protocol requirements and quality of data submitted by individual institutions on a semi-annual basis. The Committee evaluates institutional audit reports from the Data Audit Committee and quality control data from the Radiation Oncology Quality Assurance Subcommittee, the Surgery Quality Assurance Committee, the PET Committee, and other sources.

OHRP Assurances

The CALGB works with the Department of Health and Human Services' Office for Protection for Human Research Protection (OHRP). This office is responsible for assuring that the rights of patients participating in clinical research studies are protected amend the patient informed consent is documented. The CALGB audit teams evaluate institutional performance with respect to OHRP regulations.

Patient Confidentiality Right to Privacy Act

The CALGB has instituted procedures designed to protect the privacy of patients participating in clinical trials. Although there are some limits to nondisclosure of information to federal regulatory agencies, the CALGB protects the privacy of our clinical trial participants as required by law. The CALGB consent form fully describes the confidentiality policy of the CALGB. Information that would allow identification of study participants is not included in any reports or publications of the CALGB.

Policies Concerning Women and Minorities

The CALGB recognizes the importance of policies and procedures that encourage women and minority participation in CALGB clinical trials; currently, more than 50% of CALGB study patients are women.

Minority Initiative Program

The Minority Initiative program was created to increase the number of minority patients participating in CALGB studies. Particular attention is directed toward developing protocols that focus on diseases that exact a heavy toll on minority populations.

Whom Do We Serve?

The constituencies to which the CALGB is responsible include:

• The public whose taxes, in part, support the CALGB
• The patients who agree to participate in our clinical trials
• The academic institutions and their community affiliates that support our research investigators