Future-Proofing Trials with HCP Selection to Improve Source Data and Quality Management for Sponsors and CROs
Contributed Commentary by Dr A Lazarus, Medical Director, mdgroup
May 6, 2022 | Accurate information is the foundation of any quality research study, particularly when the study is decentralized or takes a hybrid approach. For decentralized clinical trials (DCTs), the appropriate selection of healthcare practitioners is all the more important to ensure patient care and data integrity.
This article will look at the role of mobile health in the DCT revolution, explain why selecting the right healthcare practitioner is so important, and offer advice on how to get the right people in the right place at the right time.
In recent years, we have seen a rise in the popularity of DCTs, with more and more clinical trial visits being conducted in the patients’ own homes. This increased adoption, which was accelerated by the COVID-19 pandemic, is being driven by a desire to streamline product development timelines and make trials more patient-centric. Remote data monitoring can, for example, accelerate recruitment, expand access, increase diversity, and facilitate more convenient, efficient data collection.
Collecting data via home visits or telehealth breaks down many of the logistical barriers to participation, including geography and the expenses and stress of travelling to sites. And since 70% of data points can be captured in this way, remote monitoring is as feasible as it is preferable.
The clinical research sector continues to evolve at unprecedented rates, and we need to remain strategic in our approach to home health, factoring it into the protocol design from the very beginning. When we give home visits and tele clinics the same weight as site consultations, we need to ensure the data collected is just as robust as it ever has been.
Trusting the Data
We all know generating and documenting accurate information at source is the most important aspect of data collection and monitoring. Yet, despite the obvious importance of appropriate HCP selection, it can be overlooked.
As the old saying goes, you can’t make a silk purse from a sow’s ear. The same can be said in clinical trials—all the quality checking in the world cannot make up for a foundation of inaccurate information.
In short, collecting poor quality data during visits can threaten data integrity and negatively impact findings. Unlike on-site staff who often have the backup of colleagues, HCPs on mobile health visits often work alone. When it comes to telehealth, the virtual modality may not be capable of capturing all the relevant information.
That’s why sponsors and CROs need to ensure the people they are asking to conduct monitoring are qualified for, and capable of, the job at hand, and that the mode of data capture is suited to the trial.
Making the Right Choice
There are lots of things sponsors and CROs can do to enhance the quality of data being collected at source during DCTs. Improving the quality of the data collection process and providing HCPs with all the support and training they need is extremely important. What’s more, no two trials are the same, so protocol-specific evaluations, which match the study to the personnel’s level of expertise, qualifications, and therapy area are advised.
Whether you are recruiting a registered nurse (RN), an advanced practice provider (APP), a physician assistant (PA), or a nurse practitioner (NP) there are several important considerations. Careful measurement begins with the physical examination, so start by thinking about the level of expertise needed to conduct the assessments in the protocol. Does the protocol specify APP or is a real time diagnosis or clinical judgement required?
If the trial does require real-time diagnosis or clinical judgement it should lead you to additional questions to help you decide on an appropriate level of expertise. Will same-day dosing impact the results of the assessment? Are assessments that would require an APP possible? For example, if a patient complains of ocular symptoms, a full endoscopic exam will be required. Is diagnosis dependent on any of the five senses? If the answer to any of these questions is yes, an MD, NP or telemedicine may be your most appropriate choice.
Some challenges can be overcome; for example, an RN could be guided via video and verbal feedback on what to assess which could make telemedicine with onsite RN support acceptable. However, there may be instances when telehealth with an RN is not conducive to quality data generation. For example, when the assessments require the skilled use of equipment the RN is not trained in or when not being physically present with the patient would affect the HCP’s diagnosis or understanding of disease severity.
Future Direction of HCP Selection
DCTs offer the clinical research industry and patients a wide range of benefits, and, as such, their use is on the rise. But new ways of working bring with them new considerations, and it’s essential we’re aware of the challenges—and how to overcome them.
Of course, every trial is different, and there is no one-size-fits-all solution to ensuring data integrity. But if the industry wants to continue reaping the benefits of the remote data collection model, the appropriate selection and deployment of healthcare practitioners is a huge step in the right direction.
Dr. Lazarus is Medical Director at mdgroup and a board-certified psychiatrist with 40 years’ experience working in health care systems, including academic medical centers, health insurance companies, and the pharmaceutical industry. His career has exposed him to many different perspectives of medical treatment viewed through the broad lens of population health. He has impacted contemporary practice through extensive speaking, writing, and traveling. Dr. Lazarus has published 4 books and over 275 articles. He is a strong advocate for initiatives to improve the mental health and well-being of clinicians and patients. He can be reached at firstname.lastname@example.org.