Conducting Clinical Research in the Private Practice
By Tiffany Lauria
Not so long ago, the phrase “clinical research” conjured images of cold, sterile hospital rooms where clipboard-equipped doctors and nurses hovered over tube-laden patients.
The medical field has thankfully evolved since then; and progressive, continued growth on the business side of medicine has turned clinical research into a highly accessible, profitable field for the private medical practice.
Conducting research in the medical practice, however, is a big undertaking. There are regulatory and safety issues, staffing, space and logistical concerns, an increased workload, and strict timelines with little to no flexibility. There is also the matter of how your patients will view your offer of clinical research participation: Will they see you as progressive, able to offer options for their care? Or will they think they’re being used for damaging experiments or a big payout from the pharmaceutical companies?
Creating a comprehensive patient-education program should be one of the first additions to your to-do list!
Many practices have enjoyed great success from incorporating clinical research offerings into the practice, as daunting as it may seem to do so. Just as with any new business line, it is vital to do your homework and initiate the project step-by-step to ensure it is launched correctly and with full buy-in from all partners and staff.
There are various forms of research that can be conducted in a practice setting. This article will focus on implementing research sponsored by pharmaceutical and medical-device companies, but many of the same considerations apply to conducting behavioral or community impact studies and investigator protocols under NIH or other federally funded grant programs.
Identify Your Motivation
When thinking of research in the medical practice, most often we think of the hundreds of community oncology practices nationwide that have crafted programs to offer the latest in research and treatment options for patients. Yet clinical trials are required in almost every specialty and treatment area to facilitate approval of new treatments and products. Even in primary care, the need for capable investigators in private practice is growing. An internal medicine practice may participate in clinical trials for a blood pressure medication or glucometer, or a pediatric practice may host trials of an investigational infant formula or antibiotic regimen for ear infections.
In the business of healthcare, there is nothing wrong with thinking of the financial security of the practice. However, conducting clinical trials is a big investment in time; and without the complete buy-in of all owners and providers, it has the potential to be a failing venture. That is why it’s important to determine whether your providers have a keen interest in the science and research aspect, or solely the financial benefits.
Here are some questions that may facilitate a conversation among board members and providers to uncover individual motivation and interest.
- Do you see a clinical need in our practice to offer research options for new treatments?
- If clinical trials are conducted, would you like to be involved as a principal or co-investigator?
- Would you be willing to spend time on the additional training needed to participate in conducting research?
- If there is no interest in being an investigator and the practice moves ahead with a decision to conduct research trials, can we expect full cooperation in identifying patients that may fit the trial’s criteria and in referring these patients to the research team?
Determine What Your Practice Has to Offer
As an inexperienced research site, it will take time for the research departments at the pharmaceutical companies and contract research organizations (see box Common Research Terms) to become familiar with you and recommend your practice as a study site. With enough outreach, you will be offered participation in a trial, and successful administration of that trial should assure future trials participation.
Knowing what your practice has to offer is key to drafting your outreach plan. This process starts with identifying the significant components of your study site.
- What is the patient population in your practice? Identify patient age ranges, gender mix, ethnicities and any other determinants that you are tracking in your practice or the community, such as illiteracy rates or prevalent languages.
- Will you be drawing trial participants from your practice only or the community?
- Identify frequently seen diagnoses and conditions, medical devices commonly used in the office or by patients in the home, and anything else that you feel your site can offer significant access to: infants needing to use formula, sleep-deprived teenagers, grandparents being caretakers, etc. Highlight unique aspects of your population. If including non-patient community members, you must gather information on the local population, as well.
- Detail the make-up of your research team: How many investigators and co-investigators will be involved in conducting actual study visits? How many other non-investigator providers will be referring patients to be trial participants? How many study coordinators or research nurses are available at the site?
You will need to market your practice as a study site very capable of conducting clinical research studies, and one with enough of the targeted population to recruit from. Your clinical practice grew from a combination of word-of-mouth, marketing, promotion and good logistics (location, etc.), so keep in mind that marketing your new clinical research line of business is not an overt play for money, it’s a necessity, as it is in your regular practice.
The other reason you will want to break down your capabilities is to ensure that all of the key decision-makers in your practice are aligned in their thinking about which clinical trials are a good fit and what the providers are comfortable with.
A cardiac practice would not be a good fit for a trial testing a new gastrointestinal regimen; but the cardiac providers may be opposed to conducting hypertension studies that have a placebo cohort. Laying out a careful framework for your clinical research department will make the launch go smoother, and adjustments can be made as a team further down the line when there is experiential knowledge.
Staff and Training
While providers in general are very good at following good clinical practice guidelines, treatment regimens, and documenting everything that is required for billing purposes, providers and staff engaged in conducting research must be excellent at adhering to the study protocol and documentation. There is very little flexibility in research. The investigator would have previously conducted a thorough review of the protocol and study-visit requirements, and contractually agreed that he or she was comfortable conducting the study. Unless a study subject presents with a situation that would make it dangerous to perform study procedures or administer the study treatment, there would be no flexibility for the provider to not follow the protocol unless he or the patient decided to withdraw participation.
Are all of your providers prepared for this shift in clinical care?
Similarly, documentation in research is everything. Even something as small as a missing temperature recording can become a big issue for a trial. The providers and staff must have more than just a desire to participate in research—they must be truly conscientious and focused on the proper administration of the trial.
At a minimum, all investigators and staff must complete human subject protections and good clinical practice training, which is offered through various organizations (and sometimes at no cost). However, an inexperienced research team may benefit from further training. A good place to start is on the websites for The Association of Clinical Research Professionals (ACRP) and The Society of Clinical Research Associates (SOCRA).
Whenever possible, having someone with experience on your research team can be of great benefit. Be sure this is someone familiar with running protocols, conducting informed consents and assents, and dealing with the Clinical Research Associates (CRAs; see box Common Research Terms) who will review your study records with a fine-toothed comb. This experienced team member does not have to be an investigator or provider. Consider hiring an experienced clinical research coordinator or clinical research nurse to anchor the department while your experience grows.
A carefully constructed patient education program can help your patients tune into the value of clinical research participation and the possible benefits to their health and the health of others. In a way, you will need to re-orient patients to your practice. They will be used to coming in, spending a few minutes with the provider, and then leaving with a treatment plan and follow-up appointment. In a practice that conducts research, that same patient may now be offered a choice to treat with an investigational product, or even a placebo, asked to read some information they may find confusing, sign consent forms, be given multiple follow-up appointments, and even receive payment!
Think ahead about what your patients will need to welcome this adjustment in their medical practice.
- Training. Have you educated your staff? From the receptionist to the physician, is the message the same? Have you given them the training needed to effectively convey this positive message to the patients?
- Education. Patient handouts and information on your practice website should simply and clearly review information such as “What is Clinical Research?,” “Why Are we Conducting Research?” and “Is Participation Required?” Updates in your patient newsletter and signage at your front desk or patient board should reinforce the basics, but also list study opportunities in a way that does not promote the idea that the patient will absolutely benefit from study participation.
- Time. Even before offering participation in a specific trial to a patient, spend a few minutes with each of your patients at their next visit to let them know about your research program and that they may be offered participation in a trial at some point. One of the biggest components of having your patients participate in a clinical study is the amount of time that will be spent with that patient in study activities and education. Set aside some time before offering a trial to increase the familiarity of your patients with research on a whole for a more welcoming response.
Is Research the Right Fit?
There are many other aspects to conducting research in your practice that will need to be considered before you make the commitment. For many practices the opportunity to offer alternative care, contribute to advancement, and supplement the practice’s bottom line with another line of business make this endeavor well worth it. Project start-up will require the most effort, but soon enough your independent medical practice can have a fine-tuned clinical research department.