Dear Arizona Pain Specialists,
I recognize the technologies of pain management are always changing. I want my practice to be innovative—not just reading about the latest breakthroughs, but actively involved in finding them. Should I consider bringing clinical research trials in-house? How do I involve my practice in research and what do I need to do to be successful?
Unsure About Research
Although there may always be national debate about whether health care should exist as a universal or private entity, we agree health care is a necessity. Humanity depends on, wants and needs good health care without hesitation. As the health care industry develops and expands in various sectors, such as nursing, health care services and products, job opportunities broaden in response. Such innovation is why health care is one of only a couple of industries that has continued to grow during the economic downturn in the United States.
Clinical research is regarded as one of the fastest growing sectors of biotechnology and pharmaceuticals; it is an imperative segment that supports growth in several divisions of the industry. Clinical research is considered a necessary component for these particular health care sectors to thrive because it provides insight into new medications and treatments for various illnesses. Without research, the field would remain stagnant. The clinical research industry requires many spheres of professional collaboration. Such demand for new technologies, paired with professional collaboration, has created continuous growth in this industry, resulting in the creation of a growing number of career opportunities.
Clinical research requires collaboration between fields. To successfully conduct a clinical research trial, experts from many areas must work together. Such groups include, but are not limited to, clinical research organizations, pharmaceutical sponsors and physicians. Essential positions fulfilling these specific needs include clinical research coordinators (CRCs) and clinical research assistants who work on research study teams with physicians. Clinical research requires a successful integration of medicine and business by providing opportunities for employers, physicians and patients, as well as pharmaceutical and corporate research companies.
Clinical trials may be categorized as one of the following:
- Treatment studies test new treatments, new combinations of drugs or new approaches to surgery and/or therapies, such as radiation or physical therapy.
- Prevention studies investigate better approaches to eliminate disease, which may include medicines, vaccines or lifestyle changes.
- Diagnostic studies evaluate better methods of testing, or procedures for identifying a particular disease or condition.
- Screening studies investigate and determine the best way to detect certain diseases or health conditions.
- Quality-of-life studies (or supportive care studies) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
During the past 20 years, the science of performing clinical research has evolved. The pharmaceutical industry has seen mergers, acquisitions and layoffs, but clinical research is still thriving. Clinical research organizations (CROs) have seen consistent growth in revenue. Even when unemployment rises, CROs see the benefit of increased patient involvement.
The following examples showcase patients’ reasons for participating in recent research:
- Participants gain access to new medicine, therapies and/or medical devices before they are available to the public.
- Participants in clinical research are given an additional treatment option that may not otherwise exist.
- Investigational products may prove to be a more effective treatment than the current standard of care.
- Participants receive frequent and in-depth individual medical attention from a research team of doctors, nurses, scientists and other health professionals.
- Participants feel heroic for contributing to the advancement of medicine.
When a patient chooses to participate in clinical research, he or she may receive the following services at no cost: medications, devices, supplies, medical exams, and laboratory and diagnostic tests. Patients also may receive compensation for their time and travel.
Carefully conducted clinical research studies are seen as the fastest and safest ways to find effective treatments, improve standard of care and identify methods to improve health care. Participating in clinical research is essential for the development of new medications and new treatments. Not only do participants experience full benefits at no personal expense, they also have the satisfaction of knowing that results from research studies may help others in the future.
Getting Started in Clinical Research: How To Find Trials
Web sites, such as CenterWatch.com or Clinicaltrials.gov, can help those interested in participating find clinical trials. On Clinicaltrials.gov, you can perform keyword searches based on topic and location (e.g., chronic low back pain & Scottsdale, Arizona). If you find a trial that interests you, reach out to the point of contact listed to inquire further. There also are Internet databases where physicians can submit practice information and select diseases and illnesses they would prefer to study based on their patient population. Other possible means of identifying clinical trials include contacting drug or medical device companies.
There also are companies that exist to help match practices with clinical trials. CROs are contracted by study sponsors to find appropriate study sites and conduct the studies for the sponsor; site management organizations (SMOs) help physicians identify and apply for clinical trials.1 These organizations vary greatly in the services they provide to physicians who are looking to become principal investigators. For example, if a physician wants to conduct research, but has little to no research staff, an SMO can provide complete management of the site’s clinical research, from assisting in institutional review board application completion and other documentation, building a site’s needed infrastructure (including staff support and equipment), as well as assisting in patient recruitment and the logistics necessary to build the study protocol into a practice’s workflow.
On the other hand, if a practice is well equipped with a CRC, research staff and other infrastructure needed to be successful, a SMO can serve as a liaison between the clinical trial sponsor and the site. SMOs such as Synergyst Research are great at locating clinical trials that match a practice’s patient population, and are instrumental in helping a site complete all necessary regulatory documents to apply for a trial, prepare for a prestudy site qualification visit, negotiate the study contract and excel at ensuring a site is recruiting and enrolling patients.
Identifying Research Personnel
Finding interesting and appropriate clinical trials is only the first of many steps to conducting clinical research. There are a number of vital personnel that you will need to ensure the success of clinical research at your practice. These include a principal investigator, CRC and subinvestigators.
The role of principal investigator is normally filled by a medical doctor whose responsibilities include, but are not limited to, making medical decisions, ensuring proper care is given to study patients according to the study protocol, adhering to numerous regulations and other ethical standards for human participant research and protection, and controlling and accounting for study drugs.
Often, new physician-researchers fail to realize the extensive management and documentation inherent to clinical trials; they begin a clinical trial scrambling to try and accommodate these demands. It is important to have a competent CRC who is designated to handle the day-to-day clinical research tasks. Physicians serving as principal investigators generally are too busy seeing patients and managing their business to also handle the day-to-day clinical research tasks, so a competent, dedicated CRC can take a lot of pressure off the principal investigator over the course of a clinical trial.
At Arizona Pain Specialists, a PhD serves as our research director. He arrived at our practice with the requisite skill set needed for us to be successful in clinical research, which has saved us many headaches in the long run. Not every site will be able to hire a PhD-trained researcher, but there are certain traits one can seek when hiring a CRC. These include someone who is intelligent, self-sufficient, pleasant, flexible, charming, compulsive, detail oriented and well organized. Although medical knowledge would be a plus, it is more easily acquired than the other qualities (especially because other medical personnel already on staff can serve as a source of this knowledge).
A CRC is sometimes referred to as a jack-of-all-trades because research permeates all areas of a practice (i.e., marketing, billing, scheduling, patient relations and interaction, facilities, and operations and processes).1 In a given day, a CRC may wear all of these hats, in addition to performing general research duties, which include scouring patient charts for study candidates, patient recruitment, patient follow-up, consenting, gathering and recording data, collecting specimen, managing and scheduling patient visits, and monitoring visits and other study meetings.
In addition to the principal investigator and CRC, a site may also have subinvestigators. These generally include other physicians, medical staff, lab personnel and anyone else who will play a role in the completion of a clinical trial.
All study personnel must complete important training before being eligible to conduct clinical research. The FDA requires that all research staff complete good clinical practice (GCP) training. GCP is an ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants. Compliance provides public assurance that the rights, safety and well-being of trial participants are protected.
Our research staff completed GCP training via an online course provided by the National Institutes of Health. Often, a course such as this will be sufficient proof of GCP training, but there are some sponsors that require completion of a specific GCP training and certification prior to initiating a study site. In the case of the protection of human participants, one can never be too careful and have too much training because protecting human rights is paramount. Additionally, research staff will also need a thorough understanding of the principles of conducting clinical trials, including their ethical and regulatory requirements.
See the May 2012 issue of Pain Medicine News for the second part of “Discovering Medicine for Your Pain Practice through Clinical Research.”
1. Stone J. Conducting clinical research: A practical guide for physicians, nurses, study coordinators, and investigators. 2nd ed. Cumberland, MD: Mountainside MD Press; 2010.
2. Arimendy C. How to start doing office-based clinical trials. June 9, 2010.
www.medscape.com/viewarticle720916. Accessed January 26, 2012.
3. Guideline for good clinical practice. www.ichgcp.net. Accessed January 27, 2012.
Drs. McJunkin and Lynch founded Arizona Pain Specialists, a comprehensive pain management practice with three locations, seven pain physicians, 10 mid-level providers, three chiropractors, on-site research and behavioral therapy. They teach nationally and are consultants for St. Jude Medical and Stryker Interventional Spine. Through their partner company, Boost Medical, they provide practice management and consulting services to other pain doctors throughout the country. For more information, visit ArizonaPain.com and BoostMedical.com.
Ms. Madan, MHA, is the CEO and Ms. Campbell is the vice president of marketing and operations for Synergyst Research. Synergyst Research contracts with physicians to assist with administrative duties and increase clinical research studies. In 2011, Synergyst Research (www.synergystresearch.net) negotiated more than 150 research studies in all specialties.
Discovery Clinical Trials (www.discoverytrials.com) partners with physicians to create research centers within private practices. As of 2011, Discovery Clinical Trials created 19 research center partnerships with physicians across the United States. For more information, email firstname.lastname@example.org or call (210) 447-2080.