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Stakeholders in drug development share the common goal of identifying new treatments that will safely extend the lives and reduce the pain and suffering of individuals diagnosed with cancer.


Priorities among these stakeholders are diverse and sometimes at odds with each other.



Responding to President Obama's call for "a cure for cancer in our time," the Pharmaceutical Research and Manufacturers of America (PhRMA) delivered a report on medicines in the research pipeline for cancer.

The report shows that America's pharmaceutical research and biotechnology companies are testing a record 861 new cancer medicines and vaccines. The medicines listed in the report are being tested in human clinical trials or are awaiting approval by the U.S. Food and Drug Administration (FDA).

"Cancer medicines being developed include 122 for lung cancer, the leading cause of cancer death in the United States; 107 for breast cancer, which is expected to strike more than 180,000 American women this year; 70 for colorectal cancer, which is the third most common cancer in both men and women; and 103 for prostate cancer, which this year is expected to kill 28,000 American men. Additional medicines target brain cancer, kidney cancer, ovarian cancer, pancreatic cancer, skin cancer, and others.

The medicines represent many cutting-edge approaches, including a drug that delivers a synthetic version of a substance derived from scorpions directly to brain tumor cells; a number of cancer vaccines; medicines that target and kill specific cancer cells; and treatments that activate the patient's general immune system to destroy cancer." - Quote from April 2009 Pharma Press Release

Medical advancements has also led to the development of equipment with 3D and 4D capabilities to define the exact extent of tumors.

The ultimate goal of drug companies is to develop effective cancer drugs that are safe and result in profit for all parties involved.

  • Drug companies often maintain relationships with all other stakeholders recognizing that a shared effort has the potential to produce faster results.
  • On average, it costs a company $1.3 billion to get one new medicine from the laboratory to patients, according to a 2007 study by Tufts Center for Drug Development.
  • Research may not include rare diseases since the return may not justify the cost of the investment.


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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





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