Eye care practitioners have taken notice of the benefits of having a clinical research capability within their clinics. The advantages are significant and include access to innovative advances in patient care, increasing the scope and reach of their practice, and developing relationships within pharma companies. Knowing how to become involved in clinical research and the process of creating a successful research center may not be intuitive.
Building a clinical research practice can be intricate and is far from a trivial task. The most impressive clinical research clinics stand out as a result of their mastery of a few critical concepts. Understanding key success factors and assessing your own clinics’ ability to handle these concepts may influence your decision to dive into the complex arena>of clinical trials.
DEDICATED STUDY COORDINATOR
Without exception, each superb clinical research site has experienced and professional study coordinators and staff who are dedicated to clinical research, and they spend the vast majority of their time focused on it. There are numerous time-consuming tasks associated with clinical trials that are above and beyond the daily routine of seeing patients. These activities involve obtaining consent from individuals and scheduling subject study visits within the time frames mandated by the study protocol. A typical clinical trial mandates comprehensive charting of every procedure referred to as source documentation, as well as the detailed collection of each data point captured via a subject case report. The study coordinator(s) will typically facilitate institutional review board or IRB applications and follow-up, maintain thorough and itemized documentation of the study drug’s receipt, accounting, and disposition, and manage and maintain ancillary study supplies. The study coordinator is the “go-to” person on the site who understands the sponsors’ day-to-day directives. Communication with the pharma sponsor or their contract research organization designees requires hours of time. A study coordinator who understands the scope of trial-related activities and nuances of the communication required with the sponsor to provide real-time, perpetual status updates is the key must-have for any clinical research practice.
CHALLENGES NOT SEEN IN THE REGULAR CLINICAL PRACTICE
The second key characteristic of a great site is for the eye care provider to understand that clinical research provides distinct challenges compared with clinical practice. Clinical research protocols demand that tasks and procedures are performed on subjects that would be superfluous in typical clinical practice. For instance, exams typically done yearly may be performed every 2 weeks during a clinical trial. Exams that an ophthalmologist ordinarily would rarely perform may be required for every subject in the study. Adherence to these tasks and procedures is critical for the standardization of the data collected as part of a study. Beyond patient care, clinical trials require investigators to participate in activities that are outside the scope of typical patient visits. The investigator will often be expected to attend an investigator meeting and participate in virtual project meetings. Principal investigators are responsible for reviewing subject data, even if the subject was seen by another eye care provider in the clinic. Investigators must be involved in the subject-consenting process. Almost always, the sponsor company is required by regulatory authorities to have a representative periodically visit a study site to monitor the study’s progress and the collection of study data throughout the life of the trial. The site study staff as well as the investigator will need to be available to those individuals at the time of the monitoring visit. Additionally, thorough audits are possible and may be initiated by the pharma sponsor, the IRB, or the FDA. If significant safety events occur, such as serious adverse events, the investigator is responsible for extensive reporting of the event(s).
REGULATORY REQUIREMENTS
Each principal investigator at a great site understands and is willing to accept the burden of responsibility that comes with running a clinical research site. The regulations that are placed on clinical studies including the sites are too numerous to mention. Good clinical practice or GCP requires constant vigilance to maintain compliance. Audits by any of these entities require significant preparation; however, the real work occurs via the adherence to all regulations during the everyday routine of study conduct (hence the need for a dedicated study coordinator). FDA Form 1572, which is viewed as a contract regarding investigator obligations with the FDA, outlines a principal investigator’s numerous responsibilities for study participation.
Guidance Compliance Regulatory Information
Code of Federal Regulations Title 21
KNOWING YOUR PATIENT POOL
Access to a large patient pool that is well known to the practice is greatly beneficial. Ease of enrollment of well-qualified patients into a trial is a critical success factor. Investigators often are used because of historical track records of data quality and enrollment achievements. Sites that have a keen sense of which patients would be candidates for a particular study based on individual study requirements are particularly successful.
CONCLUSION
Building a clinical research practice takes significant effort, but it has the potential for great rewards. The likelihood of success is directly related to your commitment to critical concepts: experienced study coordination staff, willingness to dedicate significant time resources, personal oversight and responsibility for data integrity and regulatory compliance, focused attention on your patient population, and the enrollment of appropriate subjects into a trial.
