The simple answer is that most physicians have a demanding private practice; clinical research requires new skills and knowledge, and most physicians are unwilling to commit the time to acquire such. When clinical practice physicians were asked about their willingness to participate as a principal investigator in a clinical trial, most agreed they would like to be part of adding to the body of science, but they knew little about what was required to participate as a principal investigator.
One physician in Chicago thought the physicians would be responsible for crunching the data they collected, which is a common misunderstanding. Many admitted they were not even sure what questions to ask to determine if they had the right patients for a particular clinical trial, or how to go about finding a pharmaceutical company that would select their practice as a participating site.
With the upcoming national health care plan, research might be one of the ways to diversify a private practice. Research allows physicians to remain on the cutting edge of medicine, provides patients with different options on available treatments and provides pharmaceutical companies with the necessary data to obtain FDA approval. This is truly a valuable proposition!
As an estimated $136 billion in sales lose patent protection over the next five years, pharmaceutical companies will need to bring more products to the market. There is an urgency to continue to fill the pipeline with new and innovative products to addresses the growing health care issues.
A few of the critical success factors of participating in research are:
- Ensuring the research fits the practice (i.e. picking the right trial)
- Having dedicated and skilled personnel to handle the paperwork associated
- Recruiting for patients from within and outside the practice
- Providing quality data to pharmaceutical companies
- Embracing research as part of the practice
Of the items listed above, the most difficult tends to be recruiting patients. On average, about 20 percent of sites are responsible for more than 50 percent of the patients, which means more than 50 percent of sites under-enroll or fail to enroll the pre-requisite number of patients. Only 7 percent of all sites deliver what they proposed in the feasibility questionnaire submitted to the pharmaceutical companies. A good rule of thumb is 10 percent of patients screened will actually be enrolled in a research study. On average, most studies require 10 patients to be enrolled, thus requiring 100 patients to be screened.
A successful recruitment campaign is when the entire practice is involved in screening patients to qualify for the study. From the reception desk to the physician, everyone needs to help promote research as an integral part of the practice. The staff needs to be involved in data mining; screening charts; reviewing labs; assessing medications; marketing to inactive, new and prospective patients via grassroots radio and TV; and most importantly, treating research patients as VIPs. Electronic medical records ease the burden when identifying patients; however, practices with paper records are able to accomplish similar results by reviewing billing system diagnosis and lab results.
Some clinics that dabble in research never see the true benefits of what is possible. In today’s economic climate, research provides many people with the necessary health care without the burden of co-pays, deductibles and coinsurance. If done correctly, research can be a truly rewarding experience for physicians and patients.
Trudy Madan, MHA, is the CEO of Synergyst Research and Discovery Clinical Trials.
Synergyst Research contracts with physicians to assist with administrative duties and increase clinical research studies. In 2009, Synergyst Research negotiated more than 150 research studies in all specialties. Please visit us online at www.synergystresearch.net.
Discovery Clinical Trials partners with physicians to create research centers within private practices. In 2009, Discovery Clinical Trials created eight research center partnerships with physicians across the United States. Please visit us online at www.discoverytrials.com.
For more information, e-mail trudy@synergyst.net or call 210-447-2080.
