According to a recent study, only 29% of trial results make it into journals. Only 13% of these results are reported on the ClinicalTrials.gov page two years after completing the clinical trial. The problem of trial results accessibility and transparency goes back ages.
Benefits of clinical trials transparency
Timely disclosure of clinical trial results offers numerous advantages. Patients suffering from life-threatening conditions can willingly enroll in the trial if they have access to past trial results, especially when they are positive.
Trial results can serve as CME (Continuing Medical Education) to physicians and help improve medical consultation services. The shortcomings of prior research can help scientists design better protocols. Based on trial results, the participants can make the right healthcare decisions.
Challenges of clinical trials transparency
Regulatory authorities like the FDA, WHO and Bioethics International have established rules to ensure that sponsors disclose accurate results of trials soon after completion.
However, stringent compliance rules of disclosure make it a daunting task. In this regard, challenges to accurate reporting of results are:
- The absence of a single-source integrated system that can be updated from anywhere in the world
- Maintenance of the integrity of trial recruitment by providing limited access
- User-friendly dashboards that are easy to read
- Ability to quickly review and approve requests for information from external stakeholders
- Sharing of information disclosed on one of the global registries to omit additional approval process
Patientory SaaS platform
Patientory is a SaaS (Software as a Service) that can overcome the challenges of clinical trials transparency and recruitment.
Patientory allows facilitated recruitment among stakeholders without compromising patient privacy.
It achieves this by improving the efficiency of disclosure via reducing the need for specific infrastructure since it facilitates quick, flexible, and secure access to information.
How Patientory solves the clinical trial transparency issue
The architecture of the Patientory decentralized app enables clinical trial sponsors to disclose information with ease. The encrypted middleware can handle larger volumes of information exchange without the shortcomings of any available option. Application programming interfaces (APIs) aid quick information exchange. The HIPAA-compliant storage available on the Patientory app allows sponsors to meet compliance standards without compromising patient privacy.
No one can access or alter trial recruitment identification without a private key, thereby maintaining their integrity. Patientory logs trial registration time and points, hence data can be tracked. Data sharing is also irreversible because of the underlying blockchain technology. As a result, the shared information is tamper-proof to any party without exception.
Patientory serves as a platform for patients to enroll in multiple clinical trials. It makes participant recruitment for clinical trials targeted by using e-Consenting and smart contracts. Using Patientory’s technology,TrialScope recruited participants for Phase 3 clinical trials of the Moderna COVID-19 vaccine. Hence, Patientory already solves the problem of the transparency of clinical trials in real life. Now, it is ready to deploy its solution at scale.
Conclusion
Clinical trials and companies stand to benefit from a technological intervention to comply with transparency requirements. An advanced technological system will afford timely and efficient disclosure of actual trial results. Patientory, a SaaS, provides a viable solution for clinical trial sponsors, letting them cut through the red tape and focus on ethically advancing science and health care.
