Quality in Quantity: factors contributing to optimal data collection in clinical research

May 17, 2019

Over the past few years, the focus in clinical research has been on the patient – patient engagement, patient-centricity, patient experience. Rightly so, patients should be at the core of clinical research and healthcare in general. Data collected from patients form the essence of research. People will say it is all about the data; data to support safety, efficacy and subsequently effectiveness in real world settings. Big data, another buzzword, that is thrown around in every industry a bit too recklessly, suggests that problems can be solved by analyzing billions of data points collected over time either in controlled or uncontrolled settings. Yes, maybe but not always. Specifically, in clinical research and healthcare, there are many factors that contribute to the quality of data collected and subsequently analyzed that provides evidence. Quantity, the underlying premise of big data, is not enough. Quality in quantity is imperative.

What factors contribute to optimal data collection in clinical research? If you start at the heart of clinical research, the beating chambers that supply blood to the rest of the body, these are the clinical research professionals that daily, give their all to bring us a healthier planet. Patient experience starts with these professionals and their dedication along with a great patient experience leads to quality in quantity and solving real medical problems.

For clinical trials awareness week but more for clinical trials awareness every day, we should salute those clinical research professionals who conduct and execute clinical trials, specifically, clinical operations staff and research sites. Obviously, many more people are involved including researchers, medical monitors, biostatisticians, physicians, regulatory and compliance to name a few.

Clinical Operations

Although clinical operations staff do not interact directly with patients, everything they do affects patients. Their interaction is either with the research sites directly or in the case of CROs, with sponsors. These relationships, the trust and the values that go into them, subsequently affects the patient experience – good or bad. These folks have a very difficult job keeping trials on track. As we know, each day in clinical research can be worth millions of dollars – lost or gained. They also must keep trials on track in a highly dynamic environment in the wake of well-defined protocols and SOPs. The clinical trial managers (CTM) and clinical research associates (CRA) are at the core of this group. The CRAs arguably have the most difficult job for a variety of reasons focused primarily around monitoring of research sites and patient data. First, they likely travel 80% of the time which puts a strain on them personally. Their relationships with their sites are of utmost importance because a happy site has happy patients and happy patients experience the clinical trial in a giving, holistic way leading to quality in quantity of data. The CRAs are also under pressure to generate monitoring reports which can be, but don’t have to be, time consuming, given the right configurable tools. Generally clean monitoring reports also must be delivered in a set timeframe. We at PHARMASEAL understand and are aware of the rigors and challenges of clinical operations and we salute those professionals who make it their job to optimize the site and patient experience.

Research Sites

Research sites are where the rubber meets the road. The staff at research sites; clinical research coordinators, nurses, physicians, technicians et al, directly interact with and create the patient experience to optimize quality in quantity of data. From recruitment to protocol execution to dealing with adverse experiences to study monitoring and closeout, these folks are on the front lines. To them, it probably does feel like the front lines. They must deal with sponsors, sometimes CROs, patients, caregivers, a multitude of technology, manual processes, sometimes regulatory all in line with GCP while smiling all the time. Frankly, it’s a thankless job but we at PHARMASEAL want to thank them for all that they do in the name of science, of health, of research for patients and families worldwide for a healthier planet.

Technology

Technology that has become pervasive in clinical research has helped with the quantity of data collected that can be analyzed but has it helped with the quality in quantity? There are three key aspects of quality in quantity of data collection: compliance – is the data being collected when it’s required and are patients complying; quality – is the data being collected in a quality way that can be analyzed to support (or not) the hypothesis of the study; questioning – are the right questions being asked from the data collected? This is not only true of data being collected from patients but its true of data being collected throughout the study itself from conception in the labs to study definition and protocol development to execution by clinical operations and conduct by research sites. The quality in quantity of this kind of data, the operational data, and the analysis and resulting metrics and key performance indicators is what is going to reduce clinical research timelines. Using intuitive, easy-to-use technology where user experience just like patient experience is taken into consideration allows clinical operations folks to enter data easily into systems that don’t overburden but aid in their daily work. Their jobs are hard enough without technology obstacles. Data, once collected, cannot be locked away and never heard from again. It must be used to make things better, better for the research process, better for the site and ultimately better for the patients.

Thank you to all the clinical research professionals who make our lives healthier! Michael Shilling, VP Business Development