Accelerating the delivery of promising new treatments to patients must be an international priority, according to the National Patient Advocate Foundation (NPAF), a Wash. D.C.-based nonprofit organization providing the patient's voice in improving access to quality cancer care.

The reason, according to Charles M. Balch, M.D., FACS, chair of NPAF's scientific advisory committee and professor of surgery at the University of Texas Southwestern Medical Center, is the pervasive logistical, bureaucratic, institutional and regulatory obstacles that are slowing the pace of cancer research at a time when global cancer cases are projected to reach 22 million annually by 2035, up from 14 million yearly cases today.

A white paper, Securing the Future of Innovation in Cancer Treatment, found the greatest challenge facing cancer researchers and biopharmaceutical manufacturers is the high cost of bringing a promising new treatment to patients.

Behind these escalating costs are inefficiencies in the clinical trials process, increasing regulatory requirements and delays in review decisions, all of which add years to scientific discovery and drug development. Forty percent of cancer R&D costs spent by the biopharmaceutical industry go to the administration of clinical trials and it takes nine or more years from discovery to approval for a new cancer therapy in the U.S. compared to an average time of two years for HIV drugs.

At the same time, the white paper, which was drafted through a collaborative effort led by NPAF, documents a significant return on investment from accelerating cancer discovery. Innovations in cancer detection and treatment are associated with a four year average increase in life expectancy for cancer survivors between 1988 and 2000, translating into 23 million additional life-years and roughly $1.9 trillion of additional social value.

"Given these trends, it is imperative that cancer research is accelerated. It is the only way nations will improve patient outcomes, reduce the costs of cancer care and increase productivity," said Balch. "Cancer already costs governments around the world $1.16 trillion annually and there is little hope of bending the cost curve unless there is continued progress in preventing, detecting, diagnosing and treating the more than 200 types of cancer through cancer innovation."

With the white paper as the call-to-action, NPAF is spearheading Project Innovation, a new U.S. initiative supported by a national coalition of healthcare stakeholders to build support for policy solutions that will reduce the regulatory and logistical obstacles that delay drug development, encourage a new wave of experimentation through research funding, and enhance the delivery of innovation through improved communication and coordination between providers and patients.

On a global level, policy options include:

• Facilitating collaboration among biopharmaceutical companies and research institutions to speed drug development by creating common clinical trial protocol templates, developing clinical trial networks and establishing a global investigator registry
• Establishing a centralized hub from which clinical trials data, particularly outcomes data, can be accessed and shared among government and non-government stakeholders
• Utilizing more standardized review processes that will allow for more predictability and should lead to quicker approvals and denials
• Advancing policies that support shared decision-making, a new hallmark for patient-centered care where patients and clinicians decide together on the course of treatment based on each patient's needs and goals.

At the same time, Project Innovation has identified a range of options to address inequities that limit patient access to innovative cancer treatments. These include:

   1. Applying the lessons learned from the U.K., which established a National Cancer Research Network (NCRN) to expand patient access to a portfolio of clinical trials across the U.K., to increase the number of Americans participating in cancer clinical trials. Only 2% to 5% of U.S. adult patients enroll in cancer clinical trials compared to 17% of the U.K. population, the highest national rate in the world.

   2. Instituting policies that encourage more venture capital investment in next-generation cancer therapies and incentivize innovator companies to conduct more clinical trials in the US. Currently, 70% of clinical trials are conducted outside the U.S, significantly limiting the ability of American cancer patients to get access to promising new interventions that may extend their lives.

   3. Addressing the inequities limiting patient access to innovative cancer treatments, especially the practice by Medicare and commercial health insurers to move newer cancer therapies into the highest "specialty tier" and charge patients a percentage of the drug's cost, from 25% up to 71%, according to recent estimates.

Primary funding for this initiative comes from NPAF with additional support through educational grants from Celgene, Eli Lilly, Novartis and Pfizer.