SPECIAL ADVERTISING SUPPLEMENT
Kurt Mussina, MBA, Vice President of Clinical Studies Operations, Fresenius Medical Care North America, and General Manager, Frenova Renal Research
Engaging in clinical research offers many advantages to private physicians. Providing the best possible patient care with the widest possible selection of up-to-the-moment treatment options is the most obvious. Other benefits include adding a new revenue stream and attracting and retaining more patients with the promise of better, cutting-edge care. Lastly, playing a positive role in improving the standard of care can provide meaning and help combat burnout for a physician operating a modern medical practice with its heavy load of administrative duties.
It’s no secret that for many physicians outside of academia, there are too many obstacles to conduct research — and there have been for a long time. As one participant aptly stated back in 2007 at a National Cancer Institute workshop on improving the quality of clinical trials, “There are virtually no incentives in this country for any doctor to enroll a patient in a clinical trial, and there are huge disincentives. Every [stakeholder in] the clinical trials program has to look at how they can eliminate the disincentives that they contribute to the process.”1
Since then, increasing regulations, trial complexity, and competition for study patients have only made the need to eliminate barriers to trial participation more acute. Read on as we outline four major burdens — and ways they can be relieved.
Managing Research — as a Business
Physicians often underestimate the intricacies of administering a clinical research program. To function as a successful, profitable business, a practice must establish the proper infrastructure. This foundation includes operations, financial resources, strategic staffing and training, technology, and attention to regulations.
As with any business, managing cash flow is crucial. Payments, collections, salaries, and budget negotiations must all be handled correctly to ensure good ROI. Hiring, training, and other HR functions must be performed. Furthermore, clinical research entails burdensome regulatory reporting requirements and complex data entry processes and systems.
These managerial tasks demand much more time and energy than most principal investigators (PIs) can afford. Fortunately, site management services can provide physician practices with infrastructure or even training and assistance in these areas, including recruiting, staffing, technological solutions, evaluation of accounting records to assess uncollected revenue, and more.
Finding the Next Study
Often, non-academic investigative sites fail because they don’t have a steady pipeline of new studies. Searching for the next project can be another burden that a busy practice can’t afford, and repeated failures to find appropriate trials can siphon away enthusiasm for doing research.
However, PIs associated with site networks generally have access to a steadier stream of studies. Site management business development teams seek out new opportunities to share with partner investigators, who then may decide whether studies presented are appropriate for their practices. A steady pipeline means a more consistent backlog of studies for a research team, helping to keep the clinical trial business thriving.
Slow Study Startup
Study startup is notoriously inefficient. During investigative site identification, selection, and activation, investigators often repeatedly submit the same documentation, such as copies of medical licenses, training records, CVs, and confidentiality agreements. Study-specific filing and record-keeping take up yet more time.
Investigators can benefit from assistance to streamline procedures and avoid startup delays. Frenova, for instance, has demonstrated the ability to start studies in half the time of industry averages. This improvement entails the use of master clinical trial documents and a regulatory document database. Sites with these tools in place ahead of time find negotiating less complex and can execute new agreements rapidly.
Centralized study administration can provide the business and operational expertise not only to eliminate repetitive steps, but also to coordinate necessary activities, such as site identification, patient follow-up for improved protocol adherence, ethical reviews, and regulatory submissions.
In a 2009 survey, 49 percent of startup delays were attributable to prolonged contract negotiations2 and are likely responsible for most of the site activation attempts that fail. Furthermore, ineffectual contract negotiations also cost investigator sites thousands of dollars in underestimated expenses. Engagement of site management services with personnel experienced in negotiating contracts on sites’ behalf can accelerate study startup and ensure sites are compensated appropriately.
Locating and Enrolling Patients
Perhaps the most difficult part of conducting studies is enrolling patients. Patient enrollment typically accounts for 35 – 50 percent of a trial’s timeline. Only 52 percent of clinical research sites reach enrollment targets, while 11 percent enroll no patients at all. Compounding this problem are increasingly complex study protocols with narrow eligibility requirements.
Finding eligible patients, informing them of the clinical trial, educating them about the importance of clinical research, and, finally, enrolling them require many hours of work. A busy physician practice rarely has the human resources with the requisite time or skills to accomplish these tasks. Extra staff must be brought on board but hiring them and managing them also requires time.
Investigative sites can get site management help for some of these functions. Patient counseling, follow-up, informed consent and other paperwork may be performed by externally managed site coordinators. Partnering with a site management company may mean access to other resources that can help speed enrollment and reduce the time spent on patient recruitment. Patient databases, area physician outreach, and community outreach such as advertising, web initiatives, or call centers may assist in locating patients.
A site management company may also engage in protocol feasibility assessments to optimize study designs, making the requirements practicable in the investigational setting and more palatable to patients and caregivers, thus easing recruitment and retention. An added benefit is robust protocols that do not require amendment, a great benefit as Phase III protocol amendments cost — on average — $535,000 and expend two-three extra months.4
For physicians, clinical research provides important benefits including the ability to offer patients more options, additional revenue, and job satisfaction. However, most physician practices are ill-equipped to handle the burdens that accompany study conduct and they abandon the idea: In a 2017 survey of 201 PIs, more than half quit after their first trial.5
The burdens include managing unexpectedly complex business and reporting responsibilities, finding trials to conduct, negotiating cumbersome study startup requirements, and finding and enrolling patients. All these functions entail more time, expense, and expertise than most PIs anticipate and easily overtax a busy medical practice.
Fortunately, site management companies offer expert guidance and support for management, streamlined startup, human resources and training, technology upgrades, contract negotiation expertise, and day-to-day, on-site study administration. Obtaining outside support is an efficient clinical research site strategy that allows investigators to concentrate on patient care and recruitment, mitigates challenges, and maximizes site performance and success.
About Frenova Renal Research
Frenova is the only Phase I-IV drug and device clinical development services provider dedicated exclusively to renal research. Backed by Fresenius Medical Care North America (FMCNA), the world’s largest provider of dialysis services with a network of 2,400 dialysis clinics, 250 research sites and more than 450 principal investigators, Frenova is an unparalleled resource for biotech, pharmaceutical and medical device companies worldwide. Visit www.FrenovaRenalResearch.com for more information.
1. Institute of Medicine (US). Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington (DC): National Academies Press (US); 2009.
https://www.ncbi.nlm.nih.gov/books/NBK215076/. Accessed March 13, 2019.
2. U.S. Sites Rate Novo Nordisk, Novartis and Eisai as Top Sponsors in 2009. CenterWatch Monthly. 2009;16(5). https://www.centerwatch.com/news-online/2009/05/01/centerwatch-monthly-may-2009/. May 1, 2009. Accessed March 13, 2019.
3. Getz KA. Enrollment Performance: Weighing the “Facts”: Better selection and tougher site management is not enough to improve enrollment success. Applied Clinical Trials. 2012;21(5). http://www.appliedclinicaltrialsonline.com/enrollment-performance-weighing-facts?id=&sk=&date=&pageID=2. May 1, 2012. Accessed March 13, 2019.
4. Getz KA, Stergiopoulos S, Short M, et al. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Therapeutic Innovation & Regulatory Science. 2016;50(4):436-441.
5. Corneli A, Pierre C, Hinkley T, et al. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial. Contemporary Clinical Trials Communications. 2017;6:31-38. doi:10.1016/j.conctc.2017.02.009.