5 Steps to Becoming a Research-Ready Site
May 4, 2021
PRC Clinical and CROs worldwide depend on networks of healthcare professionals and research sites to advance new drugs and disease treatments through clinical trials. Whether you’re an experienced research center or you plan to add research under your existing site practice, the developing groundbreaking personalized therapies and cures requires quality sites.
Although high-performing sites are in demand, there are about twice as many sites seeking work than there is work available. To become part of the high-performing group, make sure your facility has what it takes to enroll the right participants and execute clinical trial protocols flawlessly. Doing so could turn your practice into a scientifically and socially rewarding and potentially lucrative top-tier research site.
How Do I Get Selected as a Site?
Not only does your facility, principal investigator (PI) and patient population have to fit the clinical trial protocol, a qualified site also needs to understand the ethics and regulations behind the “Good Clinical Practice” standard imposed by the FDA and other regulatory bodies. A firm grip on these guidelines protects patients, sites, CROs and study sponsors, as well as gives your site the edge it needs to compete.
Here are a few ways you can improve your odds of selection.
#1. Accurate Feasibility Assessment
If you have not already done so, contact CROs and sponsors conducting research in your therapeutic area. If you’re a potential fit, you may receive a feasibility questionnaire, which helps the CRO or sponsor vet potential sites for each study. Few sites are right for all trials, so don’t get discouraged if you’re not selected. Keep pursuing other studies and phases of trial.
When you receive a feasibility assessment, fill it out completely and, most importantly, honestly. If you feel your site is lacking certain elements, reach out to your CRO to discuss the importance of these requirements and whether you can work around them where possible. Embellishing responses or providing the “right” answers risks enrollment, data quality and increases the likelihood your site will be removed from a study due to underperformance.
Sponsors and CROs review a number of feasibility assessments, so enrollment predictions that are significantly higher than others can indicate either embellishment or a lack of understanding of the realistic effort to recruit patients. Incomplete questionnaires generally indicate a lack of interest and rarely move to the next level of consideration.
#2. Robust Patient Network
Rapid patient acquisition is one of the first things CROs and sponsors look for in site selection. A successful site has access to a patient population broad enough to meet screening and recruitment numbers in accordance with the enrollment timeline. Affiliation with hospitals, surgical centers and specialty clinics may also help expand your reach.
Top-enrolling sites identify potential patients through medical records, electronic systems or other patient databases, as well as by researching diagnosed conditions, diseases and disorders. “For ophthalmology trials, you may want to query age-related macular degeneration patients with 20/400 vision or worse,” explains Polly Neely, Client Relationship Specialist at PRC Clinical. “Can you query both AMD and vision? Making sure you can query very detailed parts of the exam can cut through many of the general patients with exclusions that would disqualify them – saving you and the patient from fruitless efforts later.”
A referral network comes in handy here as well. For example, ophthalmologists studying AMD can reach out to other specialists – both within and outside eye disease – to expand the database of potential patients for your trial.
#3. A Place for Patients and Staff
Ensure you have space dedicated for your clinical trial work and process. Trial patients generally require the collection of more data, samples and tests than regular patients and will take more time from your staff for each visit.
Setting aside an alternate exam room or research area to house study supplies, binders and equipment is essential for the collection of quality data. A site specializing in early-phase studies needs more square footage to accommodate rounds of testing and overnight patient stays. An outpatient medical clinic may be more suitable for late-phase studies. In both cases, you’ll need to provide a work area for the study monitor.
The basic site requirements include the following:
- A dedicated computer for communication and data entry, and general trial management
- An exam room with bed
- Secure storage for supplies and records
- A room for blood draws and testing (if needed)
- A lab for specimen processing and storage
- A secure space to store drugs, with refrigerators and/or freezers to keep drugs at required temperatures
#4. Dedicated Site Staff
Resourcing a clinical study begins and ends with leadership of the PI. The commitment of the site staff often mirrors that of the PI and senior management team. Make sure your leaders set the right example.
Central to the success of any trial is a dedicated study coordinator. Clinical research coordinators oversee the majority of the study activity including administrative, data collection and management and patient-visit scheduling. Often, small or private practice sites require the study coordinator to wear multiple hats each day.
You’ll also need a dedicated team of clinicians to run the studies and meet with patients. These clinicians and their respective roles should stay the same through the duration of a study.
Site staff consistency is key to efficient enrollment and optimal trial execution. Increased turnover leads to extra time and expense to train and/or retrain staff. A revolving door of team members also increases the risk of mistakes and important steps not followed correctly. These missteps can lead to poor-quality data among other issues.
As you assemble your team, consider who will train and retrain staff. We also advise sites to designate staff to serve as alternates if a clinician leaves the team or leaves your clinic entirely. Provide robust training and document all training conducted at your site.
#5. Resources and Processes
Equipment used for clinical trials must be regularly maintained, calibrated and certified, with all those actions documented on the predetermined schedule. Investigators must secure all required certifications and accreditations for any procedures and tests performed. In addition to equipment maintenance, the site must have documented procedures on how it trains staff to use this equipment.
If you run a small practice and lack specific resources, consider partnering with local imaging, lab or medical offices that provide the testing you need. Vet these facilities thoroughly before you start a clinical trial, and be sure to maintain the documentation you used to qualify these facilities.
An additional resource worth mentioning: flexibility. Your site has to be flexible enough to accommodate a sudden priority or opportunity. If your investigator leaves, or activity slows, the ability to adapt in real time is key.
Flexibility also applies to the protocol. Does your site and staff have the flexibility to adapt to protocol amendments, eligibility criteria or the number of site visits?
Amendments to research protocols, processes and guidelines are common, and sites have to follow the protocol to the letter regardless. High-performing sites review the schedule of events in advance and develop ways to optimize performance and provide excellent outputs. Consider creating an event checklist to make sure you execute every site visit perfectly and consistently. Use patient diaries where appropriate to get a better understanding of symptom severity and quality-of-life issues. Understand what essential documents you need. When in doubt, ask the CRO or sponsor for protocol tools that can simplify your study tasks.
What Not to Do
While you can improve your odds of success with a solid patient base and experienced, dedicated staff, you can easily get your site removed from consideration. Providing inaccurate metrics in the feasibility assessment puts the study at risk of failure. If an unexplained serious anomaly is detected, sponsors will often simply remove your site from consideration.
Poor engagement is another turnoff. Lack of communication with the CRO and/or sponsor at the start of a trial can get you knocked out of consideration. Close communication through the duration of the study is required for a successful trial.
The Importance of Site Advocacy
If you’re just getting started, we’re here to help. If you’re an established site, we’ll work with you to optimize your clinic in advance of a trial to ensure site selection and preparation for study activation. PRC Clinical’s project managers and clinical research associates (CRAs) work closely with PIs and teams to make sure everyone is properly selected and trained.
Establishing a clinical research site is an exciting move, especially at a time when life sciences is advancing at such a rapid pace. As you plan your site launch, put the fundamentals in place to ensure your site regularly moves from consideration for a trial to selection and activation.
Does your site need TLC from PRC? Let’s talk.