The importance of putting the patient at the center of the clinical trial experience has been widely discussed, but clinics still seem to have trouble facilitating the patient-centric approach. The most notable reason for this is due to poor communication with patients, which will be detailed heavily in this article. Although there are several parties involved in the clinical trial process, no one is solely responsible for monitoring the patient experience.
The consequences of high patient dropout rates are significant, making it critical to understand why patients are dropping out to begin with. According to Forte Research, some of the main reasons why patients drop out include lack of appreciation, scheduling conflicts, forgetting visits, misunderstood expectations and inconvenient locations—all contributing to the average dropout rate of 30%. The research firm also noted that a whopping 85% of clinical trials fail to retain enough patients. With such high dropout rates, the FDA will not have sufficient data to approve the drug being tested, causing a significant loss of time and money.
“By putting more emphasis on patient centricity, clinical trials should see a much higher retention rate,” says Meirav Naor-Weinstock, co-founder of IMNA Solutions. “When trials fail to attend to patient needs, they not only risk having the drug denied by the FDA, but they also put patient safety in jeopardy. Clinical trial administrators need to be fully aware of what the patient is feeling, whether or not they’re experiencing side effects and any special accommodations they may require.”
However, at the crux of the patient dropout issue is the lack of synergy present in clinical trials. Pharma is tasked with evaluating a drug, CROs are responsible for simplifying the drug’s entry into the market and the FDA is examining the overall safety of the drug. Third parties are also being leveraged to recruit patients into studies. Each party has its own concern, but no one’s primary concern is patient evaluation. With all of these people serving different roles who need to relay data back and forth, there needs to be a group responsible for maintaining communication with patients from start to finish. Additionally, there needs to be a comprehensive way for all parties to communicate without losing patient data or causing redundancy for patients.
Clinical trials essentially pose a two-part problem: no one is communicating with patients, and even when communication does occur, the nature of clinical trials makes it difficult to communicate with all involved parties effectively. This requires a two-part solution: include PAGs in the clinical trial process and use secure communications technology to help reduce patient dropout rates. This will also ensure patient data doesn’t fall through the cracks.
PAGs should be involved to help establish trust between the patient and the trial and to give the patient a voice in the process. There needs to be someone making sure patients are filling out their diaries, attending their visits and reporting their experience throughout the trial. Today’s reality is that patients from all over the world are brought to a single treatment center and are largely left to their own discipline to continue with the clinical trial. Communication with patients is generally limited, and when no one is checking on how the patient is feeling, the dropout rate skyrockets. PAGs can serve as the much-needed link to bridge the communications gap between patients and trial staff.
While integrating PAGs into clinical trials would be a major step toward patient centricity, it’s equally important to not overcomplicate the communication process. A solution to better communication among all parties is to implement a secure platform that will keep all parties up-to-date with the latest patient information. Keeping all parties in the loop will help to reduce redundancy, allowing patients to have more faith in the process. With HIPPA compliant software, patients can report feelings as they occur, and PAGs can help manage the patient experience more seamlessly. This would also allow pharma to have a more thorough understanding of what the patient is going through and treatment can then be adjusted accordingly.
“It’s important to understand that each patient has different needs and a “one size fits all” approach typically doesn’t work,” says Irit Shefer, CSO, IMNA Solutions. “Clinical trials must be dynamic and flexible with the ability to address what’s happening currently while planning for future needs. This is why communications technology is essential—it caters to all parties so they can best address the patient.”
By incorporating PAGs and secure communications technology into the clinical trial process, trials will better be able to address patient needs. Patient centricity is necessary for improved clinical trial results, and communication is the necessary first step.