Stakeholders

Food and Drug Administration (FDA)

The FDA is a government agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health via its regulatory and supervisory roles.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and by helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

		Specifically the FDA is charged with: Regulating drugs, biologicals and devices from research phase to patients use while ensuring safety and efficacy. After drug approval, the FDA strives to protect cancer patients through monitoring the use of marketed drugs for unexpected health risks and communicating any new risks. The FDA strives to balance the interests of people with cancer with the need for new drugs.

 

Clear benchmarks for approving a new drug indication with marginal statistical improvements can be very controversial. Drug companies, patient advocacy groups, and individual patients have strong and sometimes conflicting opinions. The FDA must carefully assess the data, negotiate demands, and determine what is in the best interest of public health as a whole, not as individual patient or group of patients.

Patient advocates are involved in the review process through the FDA's Cancer Drug Development Patient Consultant Program helping provide the patient's perspective regarding ongoing cancer clinical trials and attending the FDA Advisory Committee meetings which evaluate data for approval.

For more information go to:
FDA U.S. Food and Drug Administration - Drug Development Patient Consultant Program

 

The National Cancer Institute (NCI)

The NCI has many roles in the drug development process:

	Conducts all phases of research - basic, translational and clinical in-house Sponsors/funds all phases of research conducted by other organizations Provides educational material for cancer patients and their families on all phases of drug research Provides an online search feature for patients and doctors to find clinical trials, and Regulates through CTEP and the CIRB

The Cancer Therapy Evaluation Program (CTEP)

CTEP collaborates with drug companies in developing new cancer drugs and testing them in different types of cancer and disease settings.

Through the NCI-FDA Oncology Task Force, the NCI provides the FDA with exposure to state-of-the-art technology to enable a better understanding of new products in development. This collaboration enhances the efficiency of clinical research and the scientific evaluation of new cancer medications and diagnostics.

 

The Central Institutional Review Board (CIRB)

The CIRB provides an innovative approach to human subject protection utilizing a facilitated review process that can streamline local IRB reviews of adult and pediatric national multi-center cancer treatment trials.

 

What is NExT?

NExT stands for the NCI Experimental Therapeutics program. NExT is a collaboration between two divisions within the NCI: the Division of Cancer Treatment and Diagnosis (DCTD) and the Center for Cancer Research (CCR).

The aim of this program is to invigorate cancer drug development at the NCI by combining the strength of DCTD's extensive expertise in anticancer drug development with CCR's dynamic in-house research and access to state-of-the-art facilities at the NIH Clinical Research Center in Bethesda, MD.

This collaboration will also utilize recent guidance from the FDA concerning exploratory studies of investigational new drugs. In this new program, certain investigational drugs will go through an evaluation process earlier than usual and thus possibly shorten the timeline for drug development. The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancer by supporting the most promising new drug discovery and development projects.

 

Why is NExT important?

Only five percent of applications for new oncology drugs submitted to the FDA IND applications are actually successful.

Some of the reasons for this low approval rate include a lack of preclinical systems to predict the efficacy and toxicity of new drugs, long timelines for drug development, high costs, and the increasing complexity of clinical trials that involve molecularly-targeted agents and advanced technologies.

Once oncology drugs make it to the second phase of clinical testing, approximately 70 percent do not advance to the third phase, often because of a lack of efficacy. NExT is designed to help address some of these problems.

For more information on the NCIs role go to:
NCI National Cancer Institute - Understanding the Approval Process for New Cancer Treatments