Are Your Mobile Research Nurses Adequately Trained on GCP?
6 things to ask about the training and qualifications of the nurses involved in your trial
The escalating growth in decentralized clinical trials (DCTs) has brought with it an array of variations as to how these trials are being implemented—all with the goal of better accommodating the patients and making it easier for them to participate as a means for improving patient enrollment and retention.
Some DCTs use wearables and other digital technologies to bring the trial to the patient. Others employ nurses who come directly to the patients’ homes or who are located conveniently in the neighborhood—either in some form of a mobile unit or at an existing retailer.
Given everything that’s on the line with a clinical trial—the significant investment, as well as the fact that human lives are literally at stake—the question regarding the type of DCT isn’t so much about where the study takes place but, rather, who is implementing the trial protocol.
The role of clinical research nurses: what they do matters
Bottom line is that it’s the quality of the healthcare professional hands that matter. So if your clinical trial is either fully decentralized or hybrid with a decentralized component, it’s critical to confirm that the nurses facilitating the trials have the necessary experience, skills and training to ensure that protocols are followed precisely without deviation and patient data is captured and protected securely.
In addition to providing and coordinating clinical care, research nurses are integral in assuring participant safety, maintenance of informed consent, integrity of protocol implementation, accuracy of data collection and recording, and appropriate follow up.
According to an article published by the National Library of Medicine, nurses who practice in clinical research are often the first to experience and work with research participants on the actual delivery and management of a new therapy, drug or device. They may be the first to have a hint of implications that later become important to the general use of the new intervention – either an adverse event or a needed modification in delivery or implementation that is important to patient tolerance and adherence. Observations made by nurses who are the agents of implementation in a clinical trial may therefore have direct bearing on the speed with which translation to the next level of testing and use can occur.
In order to achieve the best possible outcomes—for the sponsor, as well as the patient–clinical research nurses must possess the necessary clinical and critical thinking skills, and they must be well educated in the complex regulatory, ethical, and scientific aspects of clinical research.
In an interview with the Oncology Nursing Society, Elizabeth Ness, a nurse consultant at the National Cancer Institute, was quoted as saying “These nurses improve clinical trials operations and outcomes, such as increased enrollment, protocol fidelity, and protecting research participants. They are also critical to preventing delays in study completion and answering the research questions that move science forward.”
Nurse reliability and training key to trial success
Exactly how the provider of mobile research nurses qualifies and trains its nurses varies widely by provider. It was PCM Trials which, already in 2008, pioneered the concept of directly employing and training its mobile research nurses. It was PCM’s belief that a direct relationship was the best way to ensure data quality and reliability.
In more recent years, recognizing the proven benefits of direct relationships, other providers have followed PCM’s lead and have started to develop their own nursing networks. But no one has more experience in managing a global network of its own nurses than PCM Trials. As a result, the company has been able to consistently staff even the largest, most complex clinical trials despite challenges, including those presented by the global COVID pandemic.
While directly employing and/or managing nurses is a critical first step in ensuring quality mobile research nurses, it’s not the only thing that matters. Having the relevant experience and receiving comprehensive training are also critical. How do you know exactly the type of quality nurses you’re getting for your clinical trial?
According to Betsy Curry, manager of clinician assignment at PCM Trials, you should ask these six questions before choosing your mobile research nurse provider:
1. How do you screen your mobile research nurses?
“At PCM Trials, it all starts with background checks during the onboarding process,” says Curry. “But these types of standard screening tests only provide a picture of what a nurse has done prior to joining the company. To ensure that our nurses continue to maintain integrity standards, personally and professionally, PCM Trials makes the additional effort of having our nurses update and sign their resumes every two years. At this same interval, the company also screens its nurses against various debarment websites, including those from the FDA and SAM.gov.”
2. What type of experience do your mobile research nurses have?
“Real-world experience matters,” says Curry. “At PCM Trials we don’t hire nurses straight out of nursing school. Our mobile research nurses must have at least two years of related experience and are all either RNs or have some other advanced nursing degree. Most of our nurses have worked in an emergency department or ICU, which demonstrates to us that they have the necessary critical thinking skills, can multi-task, are able to work independently, and can adapt to unexpected challenges.”
3. What special skills do you require of your mobile research nurses?
“As part of our vetting process, our mobile research nurse candidates undergo a full clinical interview,” says Curry. “That includes phlebotomy verification. We need to know that they can get a vein and that they have done so recently. We also make sure they receive the necessary protocol-specific training needed for their particular clinical trial.”
4. What type of specialized training do your mobile research nurses receive?
“As part of our rigorous hiring and onboarding processes, our nurses complete good clinical practice (GCP) training, and they are regularly assessed to ensure that they are up to date,” says Curry. “Among other things, our GCP training program aims to ensure that the rights, safety, and well-being of human participants are protected; that the trial is conducted in accordance with approved plans with rigor and integrity; and that the data derived from clinical trials is reliable. A large part of that training revolves around proper clinical documentation, ensuring that all information is clear, consistent, complete, precise, reliable, timely, and legible to accurately reflect the patient’s disease burden and scope of services provided.”
Curry continues to explain that GDPR training is also provided to help ensure patient confidentiality and privacy. This includes any necessary technical training around the proper use of tablets and related privacy procedures. Through this training, PCM Trials complies with all 18 Center for Internet Security (CIS) controls. As appropriate, PCM Trials also provides dangerous goods handling and centrifuge training. This ensures that nurses properly process blood, saliva, urine, breast milk, feces, semen, hair, fingernails, nasal discharge or other bodily fluids as required by the protocols of the specific trial.
“Beyond such comprehensive training, we go one step farther than other providers in the industry by certifying our nurses,” explains Curry. “We are the only known company that provides Certified Mobile Research Nurses (CMRNs). This additional documentation speaks to our level of commitment in making sponsors and PIs comfortable in the quality of our nurses and their ability to fully conform to trial-specific protocols.”
5. What type of documentation is provided to verify that your nurses have the right background and have been properly screened?
“Our job is to make our sites and PIs comfortable in doing business with us,” notes Curry. “We don’t ever want them to wonder about the quality of the nurse assigned to their trial. That’s why we provide upfront all the necessary documents to the sites, including signed resumes and training certificates. We also send the signed delegation of authority to the site coordinator before we initiate any procedures. In this way, the PIs have the evidence they need when the FDA asks if all nurses were qualified by experience or training to perform the tasks necessary in the trial.”
6. What type of support do your nurses receive in the field?
“At PCM Trials, we’re committed to ensuring our nurses’ success. Our nurses are supported by a full team from our corporate office so they can focus entirely on the patient and the trial protocols. This includes a minimum of a coordinator and project manager for every trial. Also working behind the scenes to facilitate success are people dedicated to handling supply management and shipping logistics to ensure everything is where it should be, when it should be and at the temperature it should be,” says Curry.
“Since PCM Trials has been exclusively focused on mobile research nursing services for such a long time (unlike other providers that have expanded or been acquired to handle an array of services), we’ve had plenty of time to learn how to anticipate potential problems and plan accordingly.”
To learn more about the impact a team of highly trained, experienced mobile nursing team can have on your next clinical trial, contact PCM Trials at 866.631.9985, [email protected], visit www.PCMTrials.com, or submit an RFP today.