Stakeholders - page 2

Researchers

Researchers are focused on identifying new therapies, improved uses for pre-existing therapies, developing innovative strategies against disease, safety, efficacy, and other elements.

	Depending upon their area of focus, the work may be done in a laboratory in a clinical setting with patients, or bridge both, and thus may include partnerships involving a number of stakeholders.

• Industry, government agencies such as NCI, and academic centers employ cancer researchers.
• Different groups may be involved in different stages of research. Collaborations are also common between multiple parties such as industry, government, and academia to harness multidisciplinary expertise.

Sources of Funding

Entities that fund research include industry (pharmaceutical and biotech companies), their investors, federal and state governments, and non-profit organizations, work to identify the most promising cancer drug development research projects to advance their main priorities and those of all stakeholders. Some joint funding efforts have been more common in recent years.

Doctors

Oncologists try to keep up with the recent progress in cancer drug development, including active clinical trials, study results, and best practices of cancer care.

		This continuing education is provided by reading medical journals, relationships with drug companies, information about activities at the FDA and the NCI, and memberships to professional associations such as the: American Society of Clinical Oncology.

Differences in the use of various cancer treatments occur between individual oncologists and medical institutions. This variability can create tension between doctors in different medical disciplines, but can also motivate the entire field forward.

• Drug companies and other sponsors may be involved in researching and advancing off-label use of specific treatments. Off-label use occurs when a physician prescribes a medication for a condition other than the one for which the FDA has given approval.
• Patient advocacy groups may have their own preferred treatment strategies. The lack of consistency can be confusing for patients, but can also empower them to search for them.

Patient Advocacy Groups

Patients involved in advocacy efforts work tenaciously and creatively to move the drug development process forward to a shorter timeline and faster approval of safer, more effective therapies.

• Patient advocacy groups often work with other stakeholders to represent the patients' perspective in the drug development process.
• These groups may also partner with industry in clinical trial recruitment, patient education about treatments, and other ways.

 

Patients

Cancer patients illustrate the obvious need to advance cancer research and inspire all stakeholders to work towards the goal of safer, more effective therapies. With over 500,000 cancer patients around the world dying annually, people with cancer clearly need better treatments now and implore the system to create treatments that lead to life extension measured in years instead of months.

Although researchers and clinical trial sponsors can prepare the way for new drug development, without patients who volunteer for clinical trials, the process would stop.

	Patients who are participants in clinical trials require from doctors full disclosure and clear communication using informed consent about the potential risks and benefits of a drug under study. Treatment decisions made by people with cancer illustrate their different priorities of quantity versus quality of life. Other stakeholders must factor in these variables and the range of needs of patients. Patients are often overwhelmed by the cost of cancer drugs and seek assistance from other stakeholders such as patient advocacy groups and direct programs managed by drug companies.

Patient access to unapproved drugs

Patients diagnosed with a terminal illness may pursue access to and treatment with unapproved drugs. Cancer patients can apply for unapproved cancer drugs through FDA programs- Expanded Access and Special Exemption/Compassionate Exemption.

• Tension exists between patients, advocates, and drug companies about when to make drugs available to people with cancer. Groups may have differing views concerning parameters of safety and access. This tension is unique to cancer because of the urgency associated with survival statistics of many types of the disease.

More information can be found in the NCI fact sheet:
Access to Investigational Drugs

Drug Access: Direct Financial Assistance from Industry

Patients and their caregivers can contact the drug company that manufactures the drug to which they want access. Doctors must be involved in completing application forms.

Bristol-Myers Squibb Patient Assistance Foundation: 1-800-736-0003
http://www.bmspaf.org

Chronic Disease Fund: 1-877-968-7233
http://www.cdfund.org

 

Genentech's Single Point of Contact: 1-888-249-4918

 

GlaxoSmithKline's Commitment to Access: 1-866-265-6491

 

Lilly Cares: 1-800-545-6962
http://www.lillycares.com

 

Partnership for Prescription Assistance: 1-888-477-2669

Patient Advocate Foundation's Co-Pay Relief: 1-866-512-3861

Pfizer's FirstRESOURCE: 1-877-744-5675

RxAssist and Rx Outreach Patient Assistance Programs:
http://www.rxassist.org

Together Rx Access: 1-800-444-4106