Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator
Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access.
While study sites may receive compensation for time and resources invested in starting up and running a clinical trial, it is important to recognize exactly how much of an investment is required of study sites to be successful. Additionally, sites may invest time and resources only to discover that the trial is delayed or terminated due to issues of enrollment and other challenges.
Clinical trial delays may suffer from a variety of root causes, but participant enrollment is often cited as one of the most significant. Investigators must be realistic about their practice’s ability to recruit and enroll participants within the prescribed timelines. The ability to meet sponsors’ expectations is essential in maintaining positive relationships, which can lead to future opportunities.
Assuming the research has scientific merit and is ethical, investigators need to be realistic about their capacity before deciding to join a clinical trial. By carefully reviewing the proposal from the sponsor, and balancing the requirements of the protocol and expectations of the sponsor against the capacity of the practice, investigators can increase their chance of starting and running a successful trial.
Before agreeing to participate in a particular study, these are five questions every investigator should answer.
Do I have sufficient staffing available to execute the trial within the timelines set by the sponsor/CRO, in compliance with the protocol, and in accordance with regulatory requirements?
As studies become more complex, the time and resources necessary to start up and run clinical trials increase. It is important for investigators to have a conversation with their clinical trial staff about their workload. You may need to consider adding capacity by outsourcing administrative processes to supplement your existing staff resources.
Do I have the appropriate and sufficient patient population from which to draw participants?
Carefully review the inclusion and exclusion criteria in the protocol. If possible, run a query through your EMR to see the approximate number of potential patients that might be eligible to participate. If you do not have sufficient patients in your practice, how will you expand your enrollment efforts to the broader community?
Do I have other ongoing studies that may compete for enrollees among the same patient population?
With each clinical trial in a particular therapeutic area, your pool of potential enrollees may decrease. Carefully review your current clinical trial commitments to ensure you are not spread too thinly across a narrow patient population.
Do I have the infrastructure to support this study?
If you add staff to help with the trial, you should consider space issues. (Of course, if you have outsourced administrative duties, this is not a consideration.) Additionally, you should think about drug storage, archive space, space for documentation files, and equipment. Study monitors also need a desk or conference room when they are on-site monitoring the trial. Finally, what is your institution’s laboratory and pharmacy capacity?
Do I have the necessary credentials and expertise to conduct this trial?
Ensure that your certifications, such as Good Clinical Practice (GCP), etc., are up to date. Be prepared to provide evidence of your clinical expertise in the specialties or therapeutic areas of the study.
Investigators should agree to take on new research projects only when they can carry out the research in an ethical manner in full compliance with all regulatory requirements, as well as meet the expectations of the study sponsor. A realistic assessment of personal, practice and institutional capacity will help ensure that you are participating in appropriate trials.