Clinical Research

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According to the existing data, <5% of physicians and patients currently participate in clinical trial research, though it is critical to furthering the development of new therapies. In part, this is because most clinical research is conducted at major academic medical centers, while so much of daily medical care is delivered out in the community. This is problematic in that clinical trials often don’t achieve the numbers necessary to get conclusive data. It can also lead to significant disparities in who is represented in clinical research, as well as who has access to trials and experimental therapies.

Because of this, many non-academic physicians may find trials both a great way to contribute to advancement of the field and serve their patients better. Opportunities exist to bring clinical trials into the community. As a secondary benefit, participation in trials may also add secondary income streams to your practice.

Benefits

Benefits for Non-Academic Physicians

Participating in clinical research offers benefits not just to your and your practice, but to your patients as well.

Benefits for Your Patients

Eligible patients may benefit from new treatment options in a monitored and controlled environment. They may respond positively to these novel therapies after having less luck with standard treatments.
Eligible patients will get access to the latest technology, medications, diagnostic techniques, or equipment through studies at no additional cost to them.
Clinical trial participants usually have more frequent visits and testing, where they will receive extra care, attention, and close follow up at no additional cost to them.

Benefits for You and Your Practice

Advance medical innovation

Without clinical trials, there can be no improvements in treatment options, and without enough physicians referring appropriate patients to trials, clinical trials can be delayed or fail secondary to insufficient enrollment or statistically significant data.

Ability to offer new care options for patients

By matching and referring patients to clinical trials or actually running a clinical trial site at your practice, you offer novel approaches to treatment to your patients which can result in meaningful outcomes.

Boost your own knowledge

Being abreast of developing technology or pharmaceutical agents, risks, benefits, and side effects, will keep your knowledge base fresh.

Grow your practice and enhance your practice’s reputation.

A secondary benefit may be supporting your practice’s reputation in being up-to-date with the latest approaches and in being a strong advocate for patients. You could also be named in publications, furthering your academic profile. This could distinguish you from competitors, and help grow your practice.

If you are a clinical trial site, patients may also elect to join your practice.

Potential for compensation

As practices struggle to offset additional costs in their practice due to inflation and healthcare worker shortages as well as offset the risk of reimbursement changes from insurance companies and Medicare, many practices are looking for alternative income streams. Many times, participation in clinical trials will provide you or your practice with compensation for the extra time and effort involved with trial participation or level of care.

This is a scalable line of business, and once you become effective at running trials, you can take on more trials.

Principal Investigator

Becoming a Principal Investigator (PI)

You can work with a sponsor (such as a drug or device manufacturer) to conduct a trial as a Principal Investigator (PI). The clinical trial sponsor can be an individual, institution, government agency, or other organization that bears the overall responsibility for creating, managing, and financing the clinical trial. As the PI, you head up operations at your research site.

PI Responsibilities

Some of the responsibilities of a PI include:

Personally conduct and supervise the research
Ensuring that study personnel and other participating physicians are qualified with the right education, experience, and training to perform the study
Ensure that the clinical research participants are protected and that the research methodologies are in compliance with all local, state, and federal regulatory policies
Oversee the IRB approval and compliance process within your setting, and ensure the integrity of the data collection and analysis.
Developing budgets
Managing audits and inspections

Training

With these responsibilities, becoming a PI is an involved process that must be undertaken in a safe and ethical way. Many PIs take introductory courses on the principles and practice of clinical research. Your sponsoring organization or company will often aid you through the logistics, but you can learn more from different workshops, webinars, conferences, publications, or other guides.

Clinicians and their staff often undergo good clinical practices (GCPs) training, as it is an essential component of conducting clinical research.

You can also become certified through CITI or another reputable resource. Studying the Code of Federal Regulations (CFR) or other documents relevant to the International Council for Harmonization (ICH) will help you learn and understand the requirements of clinical research and trials. This will also help you understand the forms that you’ll be needing in order to initiate a trial.

Setting Up

If you elect to treat this as a line of business, you need proper infrastructure, including operations, finances, staff resources, technology, regulations, and training. You will need to understand the patient recruitment and enrollment process and you should also be aware of the differences between government and private payer policies.

Some of the things you will need to have in place:

Contracts
Recruiting strategies
Forms
Protocols
Regulatory documents

You will also need to ensure you equip the practice with the infrastructure it needs to conduct clinical research. It will add additional workload, so developing standard operating procedures (SOPs) that enable efficiency in conducting clinical research will be necessary to help ensure that the research is conducted in a consistent and timely manner, and that it doesn’t get in the way of clinical operations.

If you have a sponsor, they will likely inspect the study site before it is approved and once again immediately after the study starts, to ensure the practice is well equipped and prepared to execute the trial effectively and efficiently. Some changes they might request may include:

A secured room with a locking door, set aside specifically for the investigational product. At the very least, you will likely need to keep the practice’s normal drugs separate from the clinical trial drugs.
Some products may need a refrigerator, freezer, or additional shelving for storage
Any equipment that is being used has been serviced according to the manufacturer’s requirements
Safe space/technology for storage of research data and study supplies

You might want to hire an experienced study coordinator and other research members to handle paperwork, patient questions, and other logistics. The goal for you should be to focus on looking after patient care and the medical aspects of a study while your staff coordinates the rest. The study coordinator can also be a trusted employee from your practice that knows SOPs well, but is looking for a change in responsibilities or a change in career. As you add more trials, you will want more staff, as they help with several aspects essential to the success of your business:

Coordination
Recruitment
Follow-up
Documentation

You may also want to partner with a research site network, which can help you reduce overhead costs as technology, systems and training, as these can be divided across multiple sites. A site network may also offer collaborations on business strategies, marketing and patient recruitment campaigns. They can also share study lead opportunities and other strategies, as well as help you stay up to date on best practices and developments in the field. Networking with others doing clinical research is also beneficial for this reason.

There are many clinical research companies that can help you to become a principal investigator at your site, and they may even provide the staffing you need (you will usually need some extra staff members to help with paperwork, patient questions, and other logistics). While it can take some time to set up, once you are up and running, this can be great for both your patients and your practice!

Trial Databases

Identifying Trials

Sometimes, you want to refer your patients to trials, but it’s hard to know the breadth of ongoing trials. These are several ways to find these that you can either use or refer your patients to.

Online Resources

Use the search feature at ClinicalTrials.gov to find public and privately funded trials in the United States and worldwide.
Find clinical trial opportunities at the National Institutes of Health headquarters in Bethesda, Maryland. The NIH also sponsors COVID-19 trials.
For geriatric patients with neurological conditions, try the NINDS search feature (National Institute of Neurological Disorders and Stroke).
The National Cancer Institute also sponsors cancer trials. Patients can indicate cancer type, age, and zip code in text-input fields to identify suitable trials on the website.
The Mayo Clinic site features active trials recruiting patients and also those that are accepting healthy participants.

If patients find travel and lodging costs prohibitive, the Lazarex Cancer Foundation can help.

Make sure that you discuss with patients that these are just options, participation in a trial is voluntary, and that they can opt out at any time. It’s important to specifically explain the concept of informed consent in addition to the discussion of risks and benefits.

HIPAA-Compliant Software

You can actually use HIPAA-compliant technology to match patients with clinical trials. While patients may expect you to know about available trials, we know this is easier said than done. Using software such as this helps address the issue of not knowing what trials are available, as well as allows you to pre-screen whether a trial may be appropriate for your patient.

HIPAA-compliant technology platforms allow you to match patients with clinical trials in your area. They can integrate with your EHR and automatically matches patients to clinical trials in your area, and then you can review and approve whether they may be appropriate.

This allows you to connect patients to clinical trials without an upfront cost, hiring, or the time to get set up necessary with hosting a clinical trial site at your practice. You can still be reimbursed for your time and effort despite not running the trial site yourself.