By Ed Miseta, Chief Editor, Clinical Leader
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Having a highly-qualified clinical site participating in a trial can be a blessing to any operations person. Sites interact with patients, help pharma test new therapies, and provide reliable data that leads to regulatory approval. Good sites can make communication easy, follow protocols exactly, keep track of patients, and provide access to accurate data. Poor sites can require constant hand-holding and continuous oversight, all while delivering data that is incomplete or unreliable. The problem is compounded by the fact that 50 percent of principal investigators participating in a study will never participate in a second one.
I recently had a conversation with an AbbVie employee who pointed out another reason to demand competent personnel working on your trial: High-performing sites can lead to pharma companies requiring fewer sites for their studies. That can lead to quicker study start-up as well as the elimination of sites that under-recruit or recruit no patients at all.
When evaluating sites, how can you tell which ones will over-perform and which will leave you wishing you had passed on them altogether? A report published by the WIRB-Copernicus Group (WCG) provides some insights. Titled “Six Practices of High Performing Clinical Research Sites,” the report seems to be a roadmap for sites that want to improve their performance. Still, it also provides clear insights into what sponsor companies should look for when choosing their clinical site partners.
1. Good Sites Make Needed Investments
Anyone who has ever contracted with a site knows there is a difference between sites that conduct clinical research and those that are primarily a medical practice. A medical practice taking part in its first clinical trial will be reluctant to invest in, and allocate resources towards, a new study.
Sites devoted to clinical research will know that studies require staff training, a realistic assessment of the tasks and human resources necessary to conduct the research, and the commitment necessary. When choosing a site, find one that understands their staff needs time set aside for individuals to dedicate towards research. High-performing sites will have full-time staff dedicated to clinical research.
2. Find Coordinators With Strong Interpersonal Skills
A clinical research coordinator (CRC) can make or break a study. The best CRCs possess strong management and interpersonal skills. These individuals will thrive in a multitasking environment because they take an active role in managing studies. A site can submit a protocol to an Institutional Review Board (IRB) for review and then sit back and wait. That type of passive management can create unnecessary delays in a trial.
A good coordinator will take an active role in managing the progress of a study to control timelines wherever possible. One way sites can keep studies moving forward is using a central IRB for a shorter and more predictable response time.
Patient centricity is a hot topic in the clinical space. A CRC with strong interpersonal skills can be critical to providing study patients with a positive trial experience. Good communication is also vital. If your CRC is a strong communicator and stays in touch study team members, the sponsor, CRO, and other partners providing support and services, those efforts will lead to an increased probability of trial success.
3. Don’t Work With Sites That Guess
Sponsors often approach sites to ask how many patients they have that might qualify for a study. There are two ways for a site to answer that question. First, they can make a guess, based on who regularly comes into the practice to receive treatment. Unfortunately, those guesses are rarely accurate and lead to trials missing their enrollment goals, getting delayed, or getting cancelled altogether. Instead, a good site will invest the time necessary to identify and reach out to patients who may be potential participants. This effort should be conducted before the enrollment period even begins.
This is also an area where sponsors can provide assistance to sites. Effective sites will often request needed resources from sponsors. A dedicated enrollment specialist can help sites use diagnostic codes to search medical records for patients, identify potential sources of patient referrals, and engage with patient advocates and support groups.
4. Be Open To New Ideas
The sponsor company is certainly the expert on any trial. But being the expert should not make you averse to collaborating and exploring new ideas. When your study team makes a suggestion that might improve some aspect of the trial, resist the impulse to tell them, “This is the way we’ve always done it.” Your site is your partner, and you should embrace those sites that care about your study and participants and want to help you improve it. Experienced site personnel will work as if they are a member of your team, will look for areas of improvement, and will not be afraid to ask you for tools and resources that they need. Collaborating with them on what they need is the best way to keep your study on track.
5. Beware Of Sites That Overpromise
At the start of any study, sites are asked to estimate the number of subjects they will enroll. Unfortunately, 68 percent of sites will fail to meet their enrollment targets. Nothing is more frustrating to a clinical operations manager than having a trial delayed or cancelled because of sites overestimating the number of qualified patients. In a large, multi-center (or multi-national) trial, sponsors need those assumptions to be as accurate as possible. If a site wants to be contracted to participate in a trial, there can also be an incentive for them to overinflate the figures. As a result, a site estimating the enrollment of 25 participants might end up with only 10. If another site cannot enroll more patients, the study timeline immediately gets pushed out.
A similar problem can occur when it comes to recording data. A scheduled interim analysis of data will require all sites to enter data prior to a database lock. If just one site has a staffing issue and misses the data deadline, the entire study can be delayed.
While it’s not always easy to identify sites that do not overpromise, sponsors should seek out those sites that have a history and reputation for meeting deadlines and enrollment projections. Use your network and contacts at other companies to identify the best performing sites.
6. Work As One Team
Finally, never forget that your site is part of a much larger team. There are many complexities involved with managing a multi-center clinical trial. Despite these complexities, sponsors will often only have direct communication with the site monitor. Having just one source of contact with the site can make sponsors forget that the site is part of a larger team that includes study managers, medical monitors, the IRB, and safety committees. Keeping all the disparate parts informed and communicating with each other will benefit the entire clinical team.