Clinical Research

Originally published in Pain Medicine News; reprinted with permission

By Paul Lynch, MD, Tory McJunkin, MD, Ryan Tapscott, PhD, Trudy Madan, MHA, and Sheri Campbell 

See the April 2012 issue of Pain Medicine News for the first part of “Discovering Medicine for Your Pain Practice Through Clinical Research.”

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?

Sincerely,
Unsure About Research

Dear Unsure About Research,

In addition to completing the necessary training to become a clinical research investigator, physicians also must consider how to build the proper infrastructure in order to be successful. Clinical research tends to be most successful when it is integrated into the overall workflow of the practice, which requires the collaborative efforts of many different departments, including marketing, billing, patient concierge, facilities and information technology, as well as operations and clinic processes. The specific responsibilities of each department are as follows:

  • Marketing departments develop advertisements and recruitment materials, help with recruitment strategies, obtain referrals, post information about your research, direct people to the Web site and make flyers and brochures to give patients.1
  • Billing departments assist in identifying all clinical trial costs, determine and designate standard-of-care costs versus sponsor-paid costs, identify and document research participant and services, link research charges to research study account and budget development.1 It often is necessary to create separate billing and scheduling for study patients to ensure you are extremely careful not to double dip (e.g., being paid for research visits by a clinical trial sponsor and also charging patients for the same visit).
  • Patient concierge departments schedule patients for study screenings and follow-up visits, answer patient questions and concerns, and work to obtain patient records.
  • Facilities and information technology departments ensure your site has the necessary research equipment, storage, archive space and secure data management servers.
  • Operations and clinic processes departments integrate clinical trial protocol into existing workflow across all facets of patient visits in clinic.

Once you have established the infrastructure needed to accommodate your first clinical trial, it becomes much easier to conduct future trials. The first trial for which you are a principal investigator likely will come with a steep learning curve, but that will pay off with future studies.

If a sponsor believes you have the infrastructure and patient population to meet study criteria, they will schedule a prestudy site-qualification visit. During this visit, a representative from the sponsor and possibly the clinical research organizations (CROs) they are working with will visit your practice to determine if your site is qualified to participate in the trial. The sponsor will likely review the original site information survey that assesses your patient population, equipment for research purposes, the infrastructure you have in place, personnel who will work on the trial and overall space needed to comply with the study protocol.

At this point, you will probably not have access to the study protocol, but you can still establish a majority of the research infrastructure. If you are selected as a site, you will receive the study protocol. At that time, you will want to make it a priority to modify your current workflow and operations to meet the study obligations defined in the protocol. One way to make a great first impression on the sponsor is to show that your practice is prepared to conduct research by having study equipment already purchased and set up. Some common research needs that apply to almost all clinical trials include personnel, workspace and an institutional review board (IRB).2,3

Personnel include a medical doctor who serves as principal investigator, a dedicated study coordinator and any additional staff who will be subinvestigators. Workspace is needed for the study coordinator and study monitor when they visit to review completed case report forms. An IRB is required to protect the rights, safety and well-being of participants in a clinical trial; either a local IRB (at the study site or within a couple of miles) or a central IRB (a commercial IRB that provides services for multiple sites) may be used. A workspace requires a range of things, including a telephone, Internet access and email capability, a fax machine, a refrigerator and freezer, storage facilities (usually shelving, drawers and locked cabinets) for housing case report forms (CRFs), a study drug or investigational agent, and other materials for a specific study (eg, liquid nitrogen dewar, centrifuge, urine drug screen cups). You also may need to hire a pharmacist, a phlebotomist and technical support, depending on the specifics of the protocol.

Shortly after the site-qualification visit, you will be notified whether or not your practice was selected as a research site. If selected, you will need to complete the remaining regulatory documents, including FDA form 1572, which declares the investigator will abide by federal regulations regarding the use of drugs in an investigational setting, medical licenses and good clinical practice training certificates, to name a few.

You will also receive a clinical trial agreement (CTA), a study protocol and a budget for review and approval. The protocol specifies your duties and obligations during the trial. Medscape.com provides a set of nine questions to consider when evaluating a protocol and determining if the trial is right for your practice (Table).

Table. Questions To Consider When Evaluating a Clinical Trial Protocol
1. Is the protocol scientifically sound and does it have merit?
2. Do you have the staff and equipment to complete the protocol requirements?
3. Do you have the study population, or can you get the study population referred from other doctors?
4. Is the budget adequate, and is the contract acceptable?
5. Do you have the time to devote to trial oversight, attending meetings and meeting with study monitors?
6. Does it affect your regular practice operations? If so, can you integrate the protocol into your current workflow?
7. Who will manage the billing? Who will set up the research billing to avoid potential double dipping?
8. Who handles data quality and integrity, data management and study findings?
9. How will you market the site to existing and potential new patients?

If you approve the CTA, budget and protocol, and agree to become a study site, you will have to obtain IRB approval and prepare for a site initiation visit. Usually the CRO will take the practice information you have provided and submit the IRB application on your behalf. There are other instances in which you will have to prepare an IRB application and submit it to a local or central IRB for approval. Fortunately, the study sponsor will have already created the study documents, so you only will have to complete the IRB application for your site.

The Final Steps To Getting Started

The last step before actual recruitment and enrollment of participants is the site initiation visit. Usually a clinical research assistant (CRA) from the sponsor’s CRO will conduct this visit. During the site initiation visit, a CRA will provide a detailed tour of the study protocol and discuss all necessary study procedures, including the screening process, enrollment, randomization and treatment assignment, data capture using CRFs (or electronic CRFs), follow-up visits, adverse events and study termination. The site initiation visit can last several hours and normally the study coordinator is required to be present for the entire meeting. The principal investigator also will be required to attend a portion of the meeting. The overall purpose of the site initiation visit is to provide complete study training to ensure that you and your site are completely prepared to complete all study procedures.

Following the site initiation visit, your practice’s focus should be on recruiting and enrolling as many patients as possible who meet study criteria. Nearly 80% of trials fail because of an inadequate number of patients, so when you are trying to land clinical trials for your site, your primary selling point should be your ability to populate the study, making sure you can back up your promises.4 Meeting your target enrollment goal is the best way to ensure your site is selected for future clinical trials.

Establishing all the components of a clinical research program can be daunting, as it takes significant time and start-up costs. Consider it like any other investment: Be smart about selecting trials, be diligent in your review of the protocol and CTA, adequately prepare your practice and staff and closely monitor the day-to-day operations of the research so you can prosper in the long run. A successful clinical research program can result in numerous achievements for you and your practice5:

  • Developing staff professionally
  • Being at the forefront of new pain management treatments
  • Developing research partnerships and collaboration with other physicians
  • Working with investigational medications and products
  • Gaining professional recognition (often contingent on number of patients enrolled in study)
  • Presenting research at national conferences, speaking at conferences and other educational events and co-authoring papers
  • Earning continuing education credits
  • Helping in the design of future protocols
  • Being viewed as a leader within the field by assisting in the development of breakthrough drugs and treatments
  • Gaining personal satisfaction
  • Offering patients treatments that may not be available elsewhere
  • Playing a pivotal role in the advancement of pain management by helping establish new medicines and medical devices
  • Gaining a new revenue stream
  • Receiving compensation from sponsors for successfully conducting clinical trials through enrollment of participants and completion of follow-up visits
  • Properly executing studies can net practices as much as $58,000 in revenue, with net income as much as 40%.4

Although beginning a clinical research program will take a lot of time and effort, if executed properly it can be an extremely rewarding endeavor. Clinical trials are at the heart of all medical advances. Carefully conducted, quality clinical trials are the world standard for identifying and developing the best possible methods to prevent, detect and treat medical conditions and diseases, as well as develop new medical devices and procedures. These trials have the potential to change the course of pain management and the lives of patients suffering from chronic pain. In becoming an active clinical researcher, you put yourself and your practice at the forefront of a rapidly advancing field that you can help shape.

References

  1. Arimendy C. How to start doing office-based clinical trials. June 9, 2010. www.medscape.com/viewarticle720916. Accessed January 26, 2012.
  2. Stone J. Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators. 2nd ed. Cumberland, MD: Mountainside MD Press; 2010.
  3. Ginsberg D. Becoming a Successful Clinical Research Investigator. 2nd ed. Boston, MA: CenterWatch; 2009.
  4. Rollins G. Physicians find clinical research brings income and treatment options. August 1, 2002. www.sendemissary.com/Focus-on-Clinical-Investigators-Coordinators/clinical-research-benefits-for-physicians.html. Accessed January 24, 2012.
  5. Clinicaltrials.com Knowledge Center. www.clinicaltrials.com/knowledge_center/?faq_category=Investigators#. Accessed January 24, 2012.

 


Drs. McJunkin and Lynch founded Arizona Pain Specialists, a comprehensive pain management practice with three locations. 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. For more information, email trudyi@synergyst.net or call 210-447-2080.