Clinical trials are essential for developing new treatments, to understand the efficiency and safety of the drugs to be used for treating Patients. People should be encouraged to participate in clinical trials as they are going to be a part of the innovation which in turn will help a huge population of suffering patients. In our previous blog, we discussed the Challenges in Patient enrollment and retention in clinical trials and following are a few solutions to the same.
- Building awareness about clinical trials
Clinical trials are often suggested as a last option to cure. Instead, it should be presented as one of the important therapeutic measures. Increased public awareness eventually improves participation in the trials. Patients must be provided with complete information about the purpose, methods, benefits, and side effects of the studies. Clinical trial awareness week from Healthcare centers, Q&A sessions by researchers on common concerns of potential trial participants, and Events at community centers can help to reach volunteers. Videos about Clinical trials are a great way to engage with potential participants as they are more visually appealing and helps in engaging the patients throughout the trial.
- Educating Primary care physicians
Primary care providers are the trusted source of information about clinical trials to their patients.
The National Institute of Health survey on awareness about clinical trials by Health care providers (HCP) shows patients got information about clinical trials from HCP’s
- 32% patients reported that HCP’s took time and explained the trial clearly.
- 77% patients learned about the trial from HCP’s
According to the Tufts CSDD 2016 report, 82% of HCP’s are willing to refer patients if they have a good working relationship with the investigators. Such collaboration will be beneficial to Patients, HCP’s and investigators.
- Tackling Complex protocols
Increase in procedures during a trial leads to patient drop-offs, this can be addressed by the following measures
- Biomarkers – These are natural molecules used to identify a particular disease, examine organ functions, improve drug efficiency. During enrollment in Alzheimer’s study, a biomarker is used in PET scan to ensure the patient has the disease as it typically does not show any symptoms thus minimizing screen failure rates.
- In-home clinical trials – One of the patient-centric approach to increase recruitment and retention is the in-home clinical trial. The trial participants remain at home, and the samples are collected by coordinators for tests. Clinical kits are provided with all supplies and instructions to be followed at home.
- Using technology to reduce manual procedures
Patient-centric approaches are gaining significance as it helps in engaging patients by enabling self-monitoring. Real World Evidence (RWE) – One of the most reliable forms of data collected from Electronic medical records, mobiles, wearables, and social media. The Tufts CSDD 2017 study about RWE found that
- 40% of R&D relies on RWE
- 42% more companies will use Social media data in 2020
- Patient Satisfaction Survey for better retention
Patient engagement & satisfaction surveys are intended to understand the difficulties of the patient. These surveys give an insight into the changes prevailing in the ongoing procedures, emotional impact on patients and decisions for planning similar trials. It also helps in identifying which stage patients decide to quit and need special attention to be retained.
- Virtual Trials
The future of clinical trials is going to be Virtual trials in which the entire trial process happens with the help of Mobile health device. Starting from enrollment, informed consent, monitoring health status, alerting adverse effects everything would be taken care of remotely by the trial coordinator. It is reported that Virtual trials have improved Patient and investigator satisfaction ensuring higher retention rates than the traditional trial designs.
Patient enrollment and retention can be improved by increased awareness and educating everyone involved in trials be it patient or investigator. Investigators must develop protocols that are flexible and are based on the latest trends & strategies. Maintaining all the relevant enrollment data and the reasons for drop-offs is essential for devising successful trials in the future. Healthcare advancement can be done only when a patient’s queries are addressed on time.
By Mythri Raghunandan