Structures Supporting Cancer Clinical Trials
Summary of Key Points
• Cancer clinical trials provide the evidence on which sound oncology practice is based.
• Providing a greater efficiency in implementing clinical trials and achieving enrollment rapidly has been a major goal of the National Cancer Institute, cancer centers, the biopharmaceutical industry, and patient advocacy groups.
• Physicians in private practice have many opportunities to participate in clinical trials sponsored by the National Cancer Institute and/or the biopharmaceutical industry.
• Physicians and patients have online access to all U.S. sponsored clinical trials at clinicaltrials.gov and have access to additional information about cancer trials at cancer.gov.
• Successful participation in clinical trials includes the following clinical components:
• Affiliation with an institution or network that provides scientific and administrative support, such as the following:
Biopharmaceutical industry network
Access to an authorized Institutional Review Board
Access to adequate laboratory facilities to process protocol-required specimens
Adherence to good clinical practices
Accurate and timely data reporting
Proper maintenance of primary source documentation
• Many organizations now provide access to clinical trials and/or provide the necessary training and certification; relevant Web sites are included in this chapter.
1. To participate in adult cancer phase III clinical trials that are sponsored by the National Cancer Institute (NCI), a U.S. practicing oncologist can join a:
A Cooperative Clinical Trials Group
B Community Clinical Oncology Program
2. The NCI has revised its longstanding Cooperative Group program because:
A The Groups are too expensive and need to be downsized to remain affordable.
B Scientific opportunities require a different, more tightly integrated approach, with many patients requiring molecular screening to find those with specific molecular diagnoses.
C Large phase III trials are no longer needed, and NCI will focus primarily on phases I and II trials.
D The pharmaceutical industry is now performing all the phase III trials, and NCI-sponsored trials are unnecessary.
3. Before opening a NCI-sponsored phase III clinical trial, all clinical researchers must have a trial reviewed by an Institutional Review Board (IRB) that is:
A A local IRB (LIRB) duly constituted to oversee the research at the sites where the physicians conducts clinical trials.
B A central IRB (CIRB) sponsored by NCI that has made an agreement with the local institution where the physician works to oversee a specific trial.
C A commercial IRB delegated by the institution/organization where the physician works to oversee a specific trial.
4. Compared with NCI-sponsored trials, pharmaceutical-sponsored trials require:
A More frequent monitoring but fewer on-site audits.
B More frequent monitoring and more on-site audits.
5. International trials are very challenging to conduct and therefore are:
1. Answer: D. The NCI sponsors several mechanisms whereby practicing oncologists can access phase III clinical trials that are available via the menu of trials on the Cancer Trials Support Unit’s online menu of trials. Although practicing oncologists must meet membership criteria to join these organizations, motivated individuals should be able to link to one of these entities because they are distributed broadly across the United States.
2. Answer: B. The change in the Group structure was primarily performed to capitalize on new scientific opportunities. It is not anticipated that the budget for the Groups will be decreased by NCI, so there will not be a financial savings. Phase III trials are still required to discern important differences between standard and newer approaches, although larger differences in outcome are hoped for with a new generation of targeted therapies compared with differences detected in the past. Finally, although the pharmaceutical industry conducts many phase III trials, the NCI-sponsored trials fill an important niche that is unmet by industry. The NCI trials focus on combination therapies, multimodality approaches, adjuvant therapy (which often is unattractive to industry because of the length of study duration relative to a drug’s patent lifetime), and studies with radiation or surgery.
3. Answer: D. All NCI-sponsored phase III trials are reviewed by NCI’s CIRB. Institutions that have joined the CIRB are able to use the CIRB in lieu of their LIRB for these specific trials. However, this is optional, and personnel at a site can elect to have the trial reviewed by their LIRB, or they can contract with a commercial IRB to review the trial.
4. Answer: B. In general, pharmaceutical trials are being performed with a definite drug licensure plan in mind. Because of the heavy investment of companies and the need to convince the U.S. Food and Drug Administration of the efficacy and safety of their agent, the pharmaceutical sponsor usually monitors and audits their trials more extensively than does the NCI. In addition, NCI’s system is a standing apparatus that conducts many trials at the same site each year, whereas a pharmaceutical sponsor may only perform a single trial at a site and has no other experience at that site on which to rely.
5. Answer: C. International trials are commonly performed nowadays by multinational pharmaceutical companies despite the numerous regulatory differences that still exist between countries. Industry is highly motivated to perform such trials to ensure a broader market for their agent and to increase the likelihood of approval in multiple countries. The NCI also partners on selected international trials but is careful to do so only when necessary to meet accrual goals because international trials are more costly and slower to implement. Nonetheless, for rare tumors, international collaboration remains an important option for the NCI.
