Although recent coverage of health care reform has painted the American health care system as inefficient and ineffective, there is at least one tremendously important part of that system America does best: treating cancer.
America has become a leader in treating and preventing cancer largely because of the relationships physician’s have with academic medical centers and industry.
While the “pharmaceutical industry is an important driver of new drug development, academic centers often collaborate with the pharmaceutical industry to perform some of the critical clinical studies that lead to understanding drug safety and efficacy.”
Not only does industry provide financial support for such studies and development, companies also help alleviate the burden of cancer research on humans (phase I), which is lengthy and expensive. That is when industry and academia often partner together for the performance of phase I studies to help speed up the process of bringing more treatments, studies and trials of new medicines to patients. An example of this strategic alliance was recently reported in the Journal of Clinical Oncology Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP.
As one of the largest cancer centers in the world, with an emphasis on clinical trials research, M. D. Anderson Cancer Center enrolled more than 11,000 patients on a therapeutic trial in the past year, requiring frequent interactions with the pharmaceutical industry.
The project was designated “zero delay” because of its objective to activate a trial and enroll a patient without a significant delay after FDA approval of the trial’s investigational new drug (IND). Specifically, these two partners focused “a concerted effort to eliminate delays in implementing clinical trials by focusing on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially.
According to the report, in a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration (FDA) IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines.
As a result, such a partnership between academia and industry established an overwhelmingly important goal for all patients: eliminating administrative delays to accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.
With cancer being the leading cause of death in individuals younger than 85 years in the US, and with almost 11 million people diagnosed with cancer worldwide, “supporting new research and its application in the clinical is the best way to accelerate progress against this devastating disease.”
The problem of overcoming cancer itself does not only rest in science, but also in changing the slow and costly process of bringing new drugs to patients with cancer. “Administrative hurdles impede the timely initiation of cancer clinical trials and contribute to the slow pace of approval of new therapies.”
For example, it was recently documented that it takes about 800 days from initial concept to the time that a protocol document is sent to a cancer center. An additional 3 to 6 months elapses before the trial can be activated for an investigational new drug (IND) approval by the FDA and the entry of a first patient.
With a total of 1,437,180 new cancer cases and 565,650 deaths from cancer projected for the year 2008 in the US, collaboration between industry and academia must be able to shorten this process and develop drugs that can be tested efficiently. If this objective is not met, more lives will be lost to cancer.
There are also significant financial barriers that must be addressed to help industry collaboration with academic medical centers save more lives. With estimates putting the average cost of bringing a new drug to market at more than $1 billion, pharmaceutical companies need to avoid further delays in brining drug developments to the market for such investments to continue. These delays should be easy to overcome considering “almost half the steps involved in protocol activation in the study of the academic center and affiliated community practices added no discernible value.”
Ultimately, the problem with having these 2.5- to 3-year delays between concept and study activation is that there may be enough scientific progress during that time frame to render the trial or parts of it outdated. Not to mention that in that time frame alone, millions of Americans will be diagnosed with cancer. The alliance created by joining a pharmaceutical company and academic medical center can help reduce such delays and bring new treatments for cancer to patients and save lives, without eliminating any key steps in the scientific or human subjects’ safety review processes.
Such a study should be expanded in all forms of medical and disease research as a standard for expediting the research process without sacrificing safety. Continuing to move forward in this process will benefit patients immediately, and through support of industry, academic medical centers will be able to carry out such a mission.
Disclosure: Rockpointe through its accredited affiliate the Potomac Center for Medical Education has in the preceding three years received educational grant support from Astra Zeneca