Medrio Blog

Anyone with an involvement or interest in clinical research is likely to be aware of the challenges in clinical trials, and in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall by the wayside suffer that fate because of unfavorable efficacy data in the middle and later phases. Many others, though, fall victim to administrative or technical challenges — and these issues often arise not as a compound nears the finish line, but as early as the nascent stages of Phase I. Here are three obstacles that researchers commonly face early in Phase I, as well as some insight into how the right eClinical software can nip some of those obstacles in the bud. 1. Patient Recruitment Across all phases of research, challenges in patient recruitment are often accounted for by a lack of awareness of clinical trials and skepticism of the tested compound’s efficacy compared to existing treatments. Recruitment challenges in Phase I, however, have their own additional causes. Perhaps the most notorious of these is the “guinea pig” fear: as the drug’s safety and tolerability profiles have not yet been established, potential subjects often worry it may pose a danger to their wellbeing. A lack of motivation is another common factor, as most Phase I trials involve healthy volunteers with no medical necessity for the tested compound. The exception to this, of course, is Phase I oncology trials, which enroll sick patients. But even here, patients with an advanced condition and limited time are often reluctant to try a treatment with undetermined efficacy. 2. Site Negotiations Before dosing begins in a clinical trial, there is a period of negotiation dedicated to hammering out details related to administrative matters like site payments. As we discussed in a post last year, the time spent on negotiations with clinical research sites tends to decrease as research moves from one clinical phase to the next. It follows, then, that the negotiation period tends to be the longest in Phase I. In fact, Phase I site negotiations often last more than twice as long as many sponsors prefer. These lengthy negotiation periods threaten to derail timelines even before research has begun. 3. Protocol Uncertainties As Phase I oncology trials enroll sick patients instead of healthy volunteers, eligibility criteria can be strict, and dropout rates are notoriously high. This places the protocols of these trials at particularly high risk of unexpected changes. Indeed, a study by the Tufts Center for the Study of Drug Development found patient recruitment struggles to be a common cause of protocol amendments, with many amendments aiming to change patient eligibility criteria. Outside of oncology, there is another risk: the Tufts study reported that most Phase I protocol amendments take place before patient enrollment begins, and therefore create delays in the nascent stages of a trial that may be difficult to recover from as research progresses. A Software Solution to These Obstacles With these challenges lying in wait, researchers can benefit from entering their Phase I trials equipped with the tools necessary to address them. The right eClinical software can provide both direct and oblique solutions to early Phase I challenges. Medrio’s EDC makes it easy to perform mid-study changes, a feature that eases complications arising from protocol amendments. And the software has a user-friendly drag-and-drop interface that enables researchers to build studies in weeks instead of months, creating time savings that can offset any delays stemming from patient recruitment or site negotiations. The outcomes of Phase I trials set the tone for the rest of the research process. The value of a strong start, then, is difficult to overstate. While these trials face considerable challenges in their early stages, a robust and intuitive EDC like Medrio is available to mitigate those challenges.

Let’s say you’ve gone through a rigorous selection process to pick your EDC, deployed it, and are ready to train your staff. Your data management team encompasses a wide spectrum of EDC experience — some data managers have used EDC a lot, others very little — and their training needs, therefore, vary as well. But to your dismay, you discover that only one training option is available: in-person training, beginning with EDC basics, on terms and schedule dictated by the vendor. That’s a problem on several levels. For starters, coordinating schedules and finding a venue for the training can be time-consuming and inconvenient. But the bigger issue is that you’re paying for unnecessary training, delaying start times for studies, and tying up the time of your experienced users to attend sessions they don’t need. Long-time EDC users may find this scenario familiar. But at a time when the EDC industry is making great strides to optimize the user experience, it has become easier than ever to avoid. The push to make EDC more user-friendly extends beyond the software itself to include training and support offerings as well. What does this mean at Medrio? What have we learned about EDC training needs through our interactions with users, and what steps have we taken to put users in control of this essential process? Flexible eLearning for a Shorter Time to Competency We’ve spent lots of time in conversation with lots of EDC users, and found that those conversations often turn to frustrations in the training realm. Users are looking for the flexibility to deliver training by sponsor instead of being confined to an EDC-mandated training regimen. They’re finding that once their costly in-person training sessions finish covering the basics, no time remains to go over the specific needs of their studies. These conversations have thoroughly informed the flexibility with which Medrio has approached training. Users can, for example, opt-out of formal EDC training and integrate training with the Study Initiation Visit. But it’s not enough to offer flexibility through policy — just as important to users is the availability of cutting-edge resources. Observers of the EDC market have noticed that eLearning seems to be on the rise in the industry’s training offerings. With Medrio eLearning, an online on-demand training service, we’ve aimed to address common training frustrations by providing users with general competency in the software, so that any necessary subsequent in-person training can focus on their specific needs instead of going over the basics. And it allows platform users to train at their own convenience, rather than on a schedule dictated by a vendor. Individuals can advance their Medrio knowledge through instructional videos and training modules, and earn their certification. Medrio Customer Support and Services The EDC industry’s increasing focus on maximizing user experience is largely driven by technology and simplicity: the flexibility of the cloud, the rapid data entry made possible with eSource, or the ability to build studies without programming. This also ties into the broader shift from paper-based data collection to electronic methods, as discussed in our blog on ePRO vs Paper Strategies in Clinical Trials.  But on the administrative side, it’s often driven more by the notion that EDC users are entitled to a comprehensive support system that better enables them to conduct their important research with speed and ease. Here are a few things we see as essential rights for EDC users: Until recently, competition in the EDC industry was a matter of racing to convert sponsors and CROs from paper-based data management. Now that electronic processes have become the norm, however, the focus has shifted to making solutions exceptional in terms of user-friendliness. From this perspective, there has never been a better time to be an EDC user.