Clinical trials are a process that every pharmaceutical company - the sponsor - has to follow to prove safety and efficacy of a drug or a medical therapy. Clinical trials need a set of patients with relevant conditions as subjects where the drug is to be used. Results are studied, with outcomes compiled in filings that are reviewed by the Food & Drug Administration (FDA) in the USA, for regulatory authorization before mass production and use on the human population.
During COVID-19, clinical trial participation has dropped significantly due to social distancing restrictions and risk of exposure. Examples include difficulty to recruit patients, administer drugs and monitor symptoms via in-person visits to medical centers. As a result, the Decentralized Clinical Trial (DCT) was born.
DCT created the opportunity to rethink the workflow of trials by embedding digital technology into the drug development lifecycle and brought a technological shift in the way trials are managed. For example, DCTs offer patients a more streamlined experience, by reducing the burden of time-consuming in-person visits, and enabling wider patient access - especially in rural and under represented communities. As a result, patients are getting more personalized care virtually through smartphone interactions. Data collection during the trial is easier and more accurate via the mobile apps given to these patients. Decentralization also reduces hurdles for sponsors by speeding up recruitment, increasing compliance and reducing patient drop-out rates. As a result, sponsors can bring in operational efficiency and reduce trial costs.
Now let’s look closer at how technology is helping to modernize trials with process reimagination and personalization for both sponsors and patients. Through available technologies with cloud services providers like AWS or Azure, patient recruitment can be offered via a website or mobile app from the sponsor or CRO (Contract Research Organization) - replacing paper-based forms and enabling more accurate patient data capture. Administration of drugs in a timely manner is monitored via a set of reminders in the app where patients input data, including the dose taken. With a simple touch, a patient can now contact a nurse to clarify questions or get advice via video conference. Depending upon the situation conveyed, the nurse can decide to visit the patient. As a result, patients become more engaged and drop-out rates decrease.
In regards to data collection, all data are collected digitally via a periodic set of survey questions with a simple choice questionnaire. This reduces physical / paper form submissions by the nurse. As a result, data collection is less error prone. With drop-out rate reduced, clinical trials are completed within their stipulated time, thereby reducing costs.
Project Management Professionals are needed to lead building of these digital applications in record time – by breaking down process silos and managing tasks and dependencies among multi-disciplinary teams engaged in both application development and trial management. We Project Managers can be ambassadors of DCT to reimagine care and create the personalized experience deserved by patients, so that they are motivated to take medicines on time and answer surveys - all to provide quality data. As an outcome, doctors can finish trials in record time for FDA review and approval. Overall, DCTs can accelerate the drug development process, so care is available for mass consumption.
To learn more about DCTs, please see the references below.
References:
- Why Decentralized Clinical Trials Are the Way of the Future (appliedclinicaltrialsonline.com)
- Running next generation hybrid and virtual clinical trials on AWS | AWS for Industries (amazon.com}
- Empowering the new normal for clinical trials - Microsoft in Business Blogs
