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Industry, others work to boost clinical trial enrollment and efficiencies

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  2. Industry, others work to boost clinical trial enrollment and efficiencies

Clinical trials—the most important method of advancing new discoveries in cancer and other diseases—still struggle with low enrollment rates in the United States. By all accounts, the barriers to patients enrolling in clinical trials are multiple and complex and, therefore, the solutions are not simple. According to the National Cancer Institute (NCI), surveys and focus groups reveal that most cancer patients are unaware of clinical trials, and physicians are not enrolling them because they don't have the time, staff, or funding to do so. “Most patients will participate if they're asked, but the problem is the physicians are not participating because they lose money on the amount of work it takes relative to the reimbursement,” says Robert Califf, MD, vice chancellor for clinical and translational research at Duke University in Durham, North Carolina.

Dr. Califf is also co-chair of the steering committee that governs the Clinical Trials Transformation Initiative (CTTI), a public-private partnership whose goal is to identify practices that will increase the quality and efficiency of clinical trials. Its membership includes representatives of government agencies, industry, patient advocacy groups, investigators, academic institutions, and others. “The solution won't be to increase the amount of money that goes into clinical trials, given the financial constraints we're all dealing with, but to make trials more efficient and to make sure more money goes to those dealing with patients and less to inefficient and redundant procedures,” says Dr. Califf.

Indeed, surveys have indicated that the majority of patients with cancer in particular, if asked, would agree to participate in clinical trials. A 2000 survey by Harris Interactive, Inc., found that 8 of 10 cancer patients were unaware that clinical trials could be an option for them. Of the unaware patients surveyed, 76% said that if they had known about clinical trials, they would have been somewhat or very receptive to participating in them.

Industry Comes Together

CTTI is just 1 of many organizations attempting to tackle this issue. Because some 80% of clinical research is funded by industry, individual companies and group associations have taken a strong interest in enrolling more patients and improving efficiencies. “Eighty percent of clinical trials don't finish on time and 20% are delayed 6 months or more,” says Salvatore Alesci, PhD, vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers Association (PhRMA), which represents the nation's pharmaceutical and biotechnology industry. “At the same time, two-thirds of clinical trials fail to meet their original patient enrollment goals.”

Individual companies are working to improve training among physicians and investigators and to learn from clinical trial sites that have been successful at recruiting participants, says Dr. Alesci.

Additionally, in September 2012, 10 pharmaceutical companies announced that they were forming a nonprofit organization known as TransCelerate BioPharma Inc. to accelerate the development of new medicines by improving the clinical trial process. Its members are Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly & Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech, and Sanofi. “The pharmaceutical industry at large must encourage and make it easier for patients to participate in clinical trials,” says Garry Neil, MD, interim CEO of TransCelerate BioPharma. “The lack of standardization of clinical trial data, the length of time it takes to enroll patients, and the inability to offer eligible patients the opportunity to participate all hinder recruitment.”

The organization's leaders believe that increasing the number of well-trained investigators will help improve patient recruitment. Among their initial projects are the development of a shared-user interface for investigator site portals and mutual recognition of study site qualification and training.

The advantage is that oncologists who are working on trials for multiple drug companies will only have to go through qualification and training once for each company, says Dr. Califf. “A lot can be done to make trials more attractive for clinical investigators,” he says.

The Online Connection

At the same time, experts agree that the growing use of electronic health records, the Internet, and social networking may help with overall recruitment. “As electronic health records become more advanced, we hope to speed up recruitment by being able to analyze patient data and recruit them to clinical trials,” says John Lewis, vice president of public affairs for the Association of Clinical Research Organizations (ACRO), which represents the world's leading clinical research organizations (CROs). “We're not quite there yet. Right now, it's more through backend analysis of Medicare and insurance claims or pharmacy databases if patients consent that their records can be used for research.”

The Internet is a growing source of recruitment efforts, but is still somewhat sensitive due to privacy and regulatory issues, he adds. Quintiles, for example, a leading CRO that manages all aspects of clinical trials for many pharmaceutical companies' products, has developed a Digital Patient Unit (DPU) with the goal of developing long-term, consented patient relationships. The DPU enables pharmaceutical companies to leverage patients through communities Quintiles has already built, including ClinicalResearch.com and Mediguard.org. The latter is a free online service that monitors the safety of medications for more than 2.6 million patients in the United States, several European countries, and Australia. The former is an information resource on clinical trials, searchable by condition and geography.

Quintiles bills itself as the “eHarmony of healthcare, Travelocity of drug safety, and Ticketmaster of clinical trials.” PhRMA, meanwhile, has included a segment on its Web site called “Research in Your Backyard,” which helps people locate clinical trials that are being conducted in their state. Their Web site also aims to educate the public about the value of clinical trials and to address some of the misconceptions about medical research.

Other Web sites that link patients with clinical trials include EmergingMed (emergingmed.com) and the American Cancer Society's Clinical Trials Matching Service (cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/app/clinicaltrials- matching-service). Recently, both the Mayo Clinic and Pfizer launched pilot projects that tested the use of social media and online networks to recruit patients to studies. Yet, such efforts are in the beginning stages, and many more issues need to be addressed before they can be used with any regularity.

Public-Private Partnership

Dr. Califf is hopeful that with recent growing attention focused on accelerating drug development and improving clinical trials, progress can soon be made. In addition to the efforts by CTTI and TransCelerate BioPharma, a report issued last fall by the President's Council of Advisors on Science and Technology emphasizes the importance of doubling the output of innovative new medicines that meet critical health needs over the next 10 to 15 years while simultaneously improving drug safety. The group called for the creation of a public-private partnership that would include representatives from the biopharmaceutical industry, the academic biomedical research and ethics community, physician societies and pharmacists, patient-focused research foundations and advocacy groups, health insurers and providers, and the federal government. The partnership would enable each group to exchange what they are doing and coordinate with one another to identify problems and prioritize activities. “I think there's a real opportunity over the next 6 months to come up with a more consolidated national plan,” says Dr. Califf. “It will never be a monolithic national plan, but it will be a federation of ideas of different segments.”