Clinical Trial Participation: An Option That Can Benefit Many Provider Groups
By Cynthia B Blain, CPA, MBA, FACMPE
Director, Chief Operating Officer
Medic Management Group, LLC
Original Publish Date: June 07, 2016
Clinical Trials are an inventive way to bring several treatment options to a private physician practice that they would not otherwise have to offer. Most importantly it provides new therapy options to clinicians to offer to their patients. Providing cutting edge Clinical Trials offers patients and their families’ new approaches to their medical conditions as well as provide free treatment alternatives.
Clinical trials add a collaborative approach to patient care between the research professional, managing clinician, the patient and his/her family. While it entails additional efforts on all parties involved, the outcomes and contribution to further clinical research is impressive.
From the clinician’s perspective, Clinical Trials bring an additional service to the patients with an associated revenue stream. They can add significant revenue to a practice if the clinicians and support staff endorses the service, help refer into it, and support the administrative load associated with conducting trials.
If a practice wants to get involved in Clinical Trials, it is advised to find experienced, qualified staff, or a proven clinical research management company with solid experience and superior outcome results. Clinical research is an industry where experience in both conducting and managing the trials is imperative. Protocol compliance is of the utmost importance. In addition, success in recruiting appropriate and compliant patients that will participate in the studies is an indication of successful management and results in pharmaceutical sponsors’ willingness to work with you.
Several factors need to be considered in the decision to bring clinical research into your group:
- Availability of experienced, qualified staff to commit to management of the trials.
- Look at options to conduct the trials: Buy vs Build Analysis
- Space requirements for conducting trials (usually a dedicated space needs to be made for research activities).
- PI (Principal Investigator) commitment to training and some administrative duties (physical exams, reviewing labs, and reviewing other documents as required).
- Overall patient population. Is it significant enough to address various indications for studies that may be available within the specialty?
- Patient culture. Do the patients in the practice have the fortitude to look at Clinical Trials as an option for care of their medical condition?
From a Sponsor’s (pharmaceutical company) perspective, they are looking for sites where experience exists and successes can be achieved. The objective of a Clinical Trial is to determine the safety and effectiveness of new treatment options (drugs, devices, technology, etc.). Therefore, they are looking for reliable data and lots of it. As such the sites that they are willing to work with must meet the following criteria:
- Experienced principle investigators who understand the purpose, philosophy and process of Clinical Trials and have had successful experience in conducting trials
- Experienced and expertise of Clinical Trial management staff (aside from the PI). Expert in designing and customizing source documentation, data gathering and data recording. Clinical support staff will also conduct 90% of the activities related to a Clinical Trial. As such they are looking for sites that hire or contract with people who have a patient friendly orientation as well as clinically skilled staff.
- Appropriate space and equipment to support the trials that are being conducted. An initial site visit is required before a site is selected for conducting a trial. The sponsor will ensure the safety and security of the study drug and source documents as well as the site equipment safety and compliance.
- Patient populations that meet the inclusion criteria for the study indications. The practice has to have a sufficient enough patient population to ensure enough patients can be recruited to the site (including those that will not make it through the entire study).
- Ease of use. Sponsors are looking for sites where the site staff make it easy to review their data and are receptive to suggestions for improvement and corrections. Good client service skills are a must as sponsors want to work with people they like and respect.
- Ability to provide a good patient experience that offers the following:
- Access to new treatment options
- Treatments that may be more effective than their current regiment
- Close monitoring and care by the care providers of the study
- The opportunity to play an active role in their own healthcare
- A chance to contribute to clinical research and assist with getting new treatments to market for other’s suffering from the same condition.
Like anything, to be successful in Clinical Trials in a physician practice the number one priority is commitment. Adding Clinical Trials to the compliment of services offered in the practice is an exceptional way to assist patients with their continued care and maintenance of their medical conditions. It offers alternatives to patients that many other practices cannot provide. The journey of setting up Clinical Trials in a practice can take some time due to study and patient recruitment, but once the practice gets started into managing Clinical Trials, it is a steady flow of revenue and options for patient care.
Cindy manages and consults on all aspects of physician practice operations, including human resources, staffing, scheduling, accounts receivable, accounts payable, debt financing, physician compensation models, and budgeting. Her specialties include practice management consulting, practice growth strategies, physician EMR implementations, and collection management.
Cindy also oversees the strategic and operational aspect of Ohio Clinical Research Partners (OCRP), a clinical trial management company.
Cindy joined Medic Management Group, LLC in 2000 and help to start OCRP in 2006 She has more than 30 years of experience in the health care industry.
Cindy received her Master of Business Administration in accounting and finance from Case Western Reserve University and her Bachelor of Arts in political science from the University of Michigan.
Contact Cindy at cblain@medicmgmt.com