A recent study estimates that the entire cycle of bringing a drug to market costs a staggering $2.6 billion. Clinical trials are critical to approval and consequently account for a large portion of that expenditure.
Clinical trials are a complicated process with very defined procedures and protocols. Even the slightest deviation in this process can negate the results and cost both drug companies and administrators time and money.
The burden of adherence falls to the physicians conducting the trials and the subjects they recruit. So, it would stand to reason that the better the tools for tracking reactions and effectiveness, the more relevant the data will be to researchers.
Yet, studies are often put in jeopardy by relying on outdated, manual data collection. We know this firsthand at Get Real Health, as the husband of one of our employees is participating in a clinical trial. Learning about her challenges as the primary caregiver inspired us to dig deeper into this topic. Her keen insight combined with my years of executing breast cancer clinical trials gave us a deep understanding of the ways a comprehensive patient portal would increase the accuracy of clinical trials, assist participants and save money in the long run.
Here, using that experience and real-world feedback, we will explore the five ways patient portals can improve clinical trials:
1. Capturing and tracking real-time results: The very nature of clinical trials calls for participants to have a condition or medical need of some kind. That condition may compromise their ability to properly record their daily responses to a drug for a myriad of reasons. Despite the best of intentions, deteriorating health can make one forget even the simplest of tasks. However, a cutting edge patient portal can prompt a subject with alerts and reminders to not only to monitor their health but remind them to track how they are feeling, including any adverse effects due to the drug.
When subjects digitally track their health through a patient portal, their clinical team can see how the subject is reacting to the drug in real-time, which is a huge benefit. They are then able to respond and intervene if a subject is experiencing adverse events. This not only keeps them healthier, but makes them feel better, therefore keeping them interested in continuing the protocol.
As my co-worker explained, “I can’t always be there to remind my husband to take his medications or his temperature as prescribed, so if he had an alert it would relieve me of the worry when I am at work or away from home.” A subject can also authorize a caregiver, much like my coworker, to chronicle symptoms automatically when they are physically unable to do so. Conversely, some trials involve individuals healthy enough to maintain a regular routine. Providing those participants with a mobile app would allow them to chronicle symptoms and reactions on the go. The bottom line is: no more relying on handwritten notes or memory to track a participant’s experience.
2. Physician credibility: Speaking of manually chronicling, a clinical trial raises the topic of reliability. Without an easy method of noting progress and/or adverse effects, subjects are more likely to omit details or forget to write an update at all. Some participants will then have gaps in their reporting or rely on guesswork to fill in those gaps. These errors directly affect the validity of the research.
Patient portals that allow subjects to chart symptoms as well as keep a journal with text capability are the best option. With any clinical trial, there are adverse events – sometimes serious – that need to be captured. Adverse events are generally any side effect (pain, diarrhea, abnormal readings from devices, and noncompliance with medications); serious adverse events are things that are more life threatening (events that bring you to the ER, events that cause irreparable damage).
These trials dictate that the physicians receive ‘deviations’ or dings on their record for any errors in documentation. Errors can be as simple as putting down the wrong date next to a signature or not filling out a form correctly. An effective portal helps ensure that these adverse events are not only noted but treated. If participants feel healthier and cared for, they are more likely to remain invested in the clinical trial, leading to fewer deviations. This is important because the more deviations a physician records, the more likely it is that involvement in an upcoming study won’t be an option. Participating in these studies not only offers prestige because of the contribution to furthering treatment options, but also garners substantial payouts to physician practices. This compensation can make a substantial difference to a practice running on tight financial margins. These obstacles can be alleviated or eliminated altogether with a comprehensive patient portal.
3. Device connectivity: Many clinical trials require readings from remote devices. For instance, research regarding blood pressure would necessitate obtaining a blood pressure score at least once a day and possibly more. Patient portals can relay this data immediately to a physician who, in turn, can see if a reading is unhealthy or missing. Study participants benefit from automatic uploads as well. This type of connectivity means fewer notations for patients. Not only can subjects send the reading to a physician, but they can log on at any time to see that score in relation to other readings and target ranges presented in a chart or graph. Seeing these trends offers a deeper understanding of personal goals, leading to an investment in the study’s goals as well.
4. Decrease in clinical staff workload: Any clinician who has scoured reams of medical files searching for relevant data and adverse events will attest that it is painstaking work. Not only do adverse events need to be identified, but they are then graded on a scale of 1–4 for severity. This process is repeated frequently during site visits. This puts a tremendous burden on staff over the course of a clinical trial, a burden that could be reduced with access to reports generated from a patient portal. Not only would the data be available in real-time, it would also provide more accurate results. Staff would then be better utilized, improving efficiency overall.
5. Recruitment and retention: Finding subjects willing to participate in a clinical trial is a difficult task. Even with compensation and access to treatment options not otherwise available, many people find that the hardships outweigh the benefits. However, the right tools can tip the scales and make it easier to commit to the regimen. Remote patient monitoring reduces the number of office visits necessary without compromising compliance. Tools like alerts, action plans with clearly delineated tasks, and access to test results and labs, take away many of the objections of potential participants. The ability to securely message through a portal is also a big advantage for participants and physicians alike. Communication outside facility walls allows clinical staff to impart instructions and detailed information, while the message format creates a permanent record patients can refer back to and easily ask questions regarding their treatment.
All of these reasons together create one common end goal – a cost savings without sacrificing relevant data. Moreover, this technology establishes the real possibility of improving accuracy and saving people’s lives. A patient portal can act as the gateway to more effective, streamlined clinical trials, healthier individuals and increased revenue for physicians.
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