A stubborn shortage of principal investigators (PIs) who are willing to manage and conduct clinical trials can be reversed by more effectively educating private practice physicians about their benefits, says Christina Kahn, CCRP, Senior Director for Site Alliance Management and F1RST Up™ Site Network Manager at Frenova Renal Research. She kindly responded to the following questions from ACRP through an interview on March 23.
ACRP: What has caused the shortage of PIs managing and conducting clinical trials?
Kahn: The shortage can be attributed to many reasons, most of which derive from the general demand and complexity of the job itself. Physicians engaged in clinical research often face difficulties balancing their practice workload with the oversight of their research staff and the conduct of the clinical trials. This includes recruiting patients, understanding technology, managing multiple systems, keeping up with the constantly changing regulatory environment, and finding time within their day-to-day schedules to train and facilitate contracts, budgets, new software, and other mundane, though necessary, tasks associated with clinical research. The level of difficulty of the job, combined with unrealistic expectations from sponsors and delayed reimbursement and inaccurate payments, has contributed to a high turnover rate and a shortage of investigators in clinical trials.
ACRP: What are some practical solutions in terms of educating private practice physicians?
Kahn: Educating private practice physicians of both the benefits and the challenges of participating in clinical research is the key to eliminating the investigator shortage problem. The best way to educate physicians is to—first and foremost—reach them through articles, conferences, webinars, and training opportunities, and to explain, in their language, the benefits of conducting clinical research. It is essential to provide them upfront with easy-to-understand resources on how to get started, establish a sound infrastructure, run their research site efficiently as a business, and overcome trial conduct challenges.
ACRP: What can be done to better attract investigators to be proactive with patients by suggesting patients explore potential trial opportunities?
Kahn: To attract physicians, they must be reminded of the benefits involved—both for them and their patients. Participation from investigators can lead not only to extra financial income for their sites, but also to being recognized for cutting-edge research while also enabling them to provide additional options for patients, to assist in the advancement of clinical research for future generations, and to help increase the well-being for all patients worldwide.
To encourage physicians to be more proactive with their patients and suggest trial opportunities, they must be reminded of their role in providing the best care options for their patients. With that in mind, they must understand that clinical research has been shown to improve participants’ health outcomes because they receive extra attention during a clinical trial, which encourages them to become more actively engaged in their own care. Patients are more likely to participate in clinical research when invited to do so by their physicians and trusted nursing staff. Through an engaging environment of caregivers, researchers, and patients, significant innovations in patient care and novel therapies can be brought and designed to improve the lives of all patients.
ACRP: What’s being done today (and what could be done in the future) to assist physicians in the implementation and maintenance of seamless clinical research and explore solutions for the challenges that remain?
Kahn: The key to successful implementation of clinical research is complete transparency of communication between sponsors, contract research organizations (CROs), investigators, and patients. Although challenges still remain, many sponsors and CROs are collaborating with physicians to find better ways to implement and maintain seamless clinical research. Protocols are being designed to keep the patients’ and the investigators’ needs in mind—some, for example, allow for increased patient screening and enrollment time or limited enrollment in order to manage demand for the investigators’ logistical resources.
Professional financial systems and greater resource planning tools, technologies, and services are being developed and implemented to help expedite payments and optimize processes. However, there are still additional steps that need to be taken by sponsors and CROs to decrease the challenges physicians face, such as the development of simpler, integrated training in areas such as contract completion, regulatory documentation, data entry, and patient recruitment.
Author: Michael Causey
Related: Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project
Sunday, April 29, 2018 at ACRP 2018
GCP training has become the industry standard for meeting sponsors’ responsibility to ensure qualified investigators. Despite the widespread use of this training, little evidence has been collected to determine whether it provides the knowledge and skills necessary to support investigators and their delegates in the quality conduct of clinical trials. In addition, the burden of training that is redundant or of little value, often required before each clinical trial, could make it untenable for investigators to participate in future trials. Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative’s multi-stakeholder project team has worked to gain a broader, evidence-based perspective to inform the efficient and effective qualification of site investigators for the quality conduct of clinical trials. Come learn about their findings.