TOOLS, PRODUCTS, AND RESOURCES

Patient Information about NCI Clinical Trials

• Finding Clinical Trials
• Searching for Cancer Clinical Trials
• Tracking Clinical Trial Results
• ClinicalTrials.gov
• Clinical Trials Reporting Program (CTRP)
• International Collaboration
• Costs of Clinical Trials for Patients and Insurance Coverage
• Centers for Medicare and Medicare Services

Finding Clinical Trials

http://www.cancer.gov/clinicaltrials/education/treatment-trial-guide

This link provides a detailed, yet simple guide entitled “How to Find a Cancer Treatment Trial,” which helps patients to:

• Gather the information they need to search for a cancer treatment clinical trial
• Identify a wide variety of sources that list clinical trials
• Learn about clinical trials that are of potential benefit to them
• Ask questions that will help them decide whether or not to participate in a particular trial

Searching for Cancer Clinical Trials

http://www.cancer.gov/clinicaltrials/search

This is the entry to the NCI’s database of cancer clinical trials. Protocol summaries are provided in lay language for patients and in a more detailed format for health professionals. A search form for the database is provided, and an advanced search feature is also available.

Tracking Clinical Trial Results

http://www.cancer.gov/clinicaltrials/results/

This link provides the means for monitoring progress in cancer care by providing summaries of recently released results from cancer clinical trials that may affect medical care. The summaries are listed in reverse chronological order. Navigation tools allow searching by keyword or type of cancer. The site also includes links to other patient information materials.

ClinicalTrials.gov

http://clinicaltrials.gov/

This website provides regularly updated information about federally and privately supported clinical research in human volunteers. It includes all diseases and gives information about a trial’s purpose, who may participate, locations, and phone numbers for more details.

Clinical Trials Reporting Program (CTRP)

http://www.cancer.gov/clinicaltrials/conducting/ncictrp/main

This link provides the visitor with information on a new NCI initiative to collect all NCI funded clinical trial data into one central repository. The objective of the CTRP is to retain this information in one central database allowing NCI leadership to better manage its extensive portfolio of clinical trials it sponsors and to provide the information to allow for the development of high quality, high impact clinical trials.

International Collaboration

From the early days of the NCI’s National Cancer Chemotherapy Service, which was the original name of the NCI’s clinical trials network, investigators from the United States and Canada have collaborated in the development and conduct of clinical trials. More recently, academic sites and Cooperative Groups elsewhere in the world have joined these efforts. Clearly, the participation of more sites and more investigators in clinical trials will permit faster accrual and thus faster answers to clinical questions. In addition, international participation will permit the NCI to leverage public investment in clinical trials infrastructure in many countries both for rare and common diseases. Challenges to greater international collaboration include regulatory and administrative barriers. CTEP staff are working closely with investigators and program staff in many other countries to determine how best to overcome these barriers.

The purpose of this effort is to identify and remove barriers to effectively working with international partners to develop cancer clinical trials. As adult enrolment in clinical trials is less than 5 percent and cancer climbs to the number one cause of death worldwide, the need to expand the recruitment of patients into clinical trials has become of paramount importance to investigators. Greater collaboration intends to accelerate the rate of new discoveries in the fight against cancer.

In 2011, NCI created the Center for Global Health (CGH) (http://www.cancer.gov/aboutnci/globalhealth) to support the Institute-wide goal of advancing global cancer research, building expertise, and leveraging resources across nations to address the challenges of cancer and reduce cancer deaths worldwide.

Costs of Clinical Trials for Patients and Insurance Coverage

http://www.cancer.gov/clinicaltrials/conducting/cost

As lack of health insurance coverage is a barrier for patient participation in cancer treatment trials, this link provides information for to help understand coverage issues. Information includes:

• A searchable list and map of US states that require health plans to pay for the patient care costs associated with clinical trials. Key provisions are summarized
• Information about insurance coverage of the patient care costs associated with clinical trials
• Results from NCI supported studies that investigated the cost of patient care for patients enrolled in NCI-sponsored clinical trials compared to care received for comparable patients in standard community care

Centers for Medicare and Medicare Services

http://www.cancer.gov/clinicaltrials/conducting/developments/ncd179n

The Centers for Medicare and Medicare Services (CMS) and NCI have been collaborating on a pilot program that ensures beneficiaries rapid access to promising new uses of technologies under controlled clinical trial conditions. CMS issued a National Coverage Determination (NCD) to cover the off-label use of certain anti-cancer drugs and nine specific CTEP-sponsored clinical trials of colorectal cancer and other cancer types were identified for Medicare to provide coverage. This pilot has been successful as approximately one third of the patients participating in these 9 NCI-CMS trials have been age 65 or older, a significantly larger proportion of older patients on trials than is typically seen. It has been challenging to recruit older individuals to clinical trials, despite the increasing incidence of cancer with age. The results from this pilot suggest that lack of insurance coverage is an important barrier.