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Forecasting Drug Development

    Business Insights

    Today’s Forecast: 5 Predictions About the Future of Clinical Trials

    by William McEwen May 20, 2020
    written by William McEwen

    There is a popular saying: “It’s difficult to make predictions, especially about the future.” Correct, but that didn’t stop me from asking Imperial leadership for their thoughts on what we might see in the years to come.

    Balancing innovation and risk

    The COVID-19 pandemic has created a phenomenon impacting both personal and professional lives — “COVID Time.” In COVID Time, we are seeing many aspects of our personal lives slow down, become more home and family centered, and making us acutely aware of the blessings that the world provided during normal times. Professionally, especially in the world of clinical research, the opposite is happening. We are experiencing a rapid acceleration of time. The race for testing and vaccines has driven down bureaucracy for the sake of critical efficiency. There is NO TIME to spare. It has done something else which is truly profound. It has forced the industry to move outside of its comfort zone after years of resisting, fumbling, and bumbling. We no longer have any option than to embrace technology and other unconditional approaches to decentralize clinical research away from the study site. If the patient can’t come to the trial, we have to bring the trial to the patient, and that is what is happening in record time. Protocol rewrites and approvals are taking place, with visits to the study site replaced by telemedicine, visiting study nurses, video conferences, remote diagnostics, supply chain workarounds, and much more. My original pre-pandemic contribution to this blog post had me predicting a much longer, but successful breakthrough of these approaches to streamline and decentralize research. Perhaps some incremental progress in 2020. Instead we are blasting forward at record pace. If there is a silver lining to COVID-19, it may be that it came with a time machine — and entrance was mandatory.

    Dan McDonald, vice president, global business development

    No recruitment challenges or attrition rate issues

    I predict a point where there is no such thing as poor attrition rates or issues with recruitment for trials. Why? Because they will be designed completely around the inclusion of the patient. More importantly, trials will become a part of life and something almost every person in the world will be on at any given time. Clinical trials are by nature a study of humans and our responses to treatments, products, or drugs, so I predict most people will access innovative treatment by trials.

    Imogen Cheese, Imperial director of business development, U.K. and Europe

    Expanded-purpose wearables

    Wearables will be developed that notify patients and EMS services of precursors to adverse events. They will interface with the patient’s autonomous driving system to redirect the passenger to the nearest ER or safe location for the intervention of EMS services.

    Steve Swanson, Imperial president and COO

    Gene counselors and genetic testing

    We continue to expand our understanding of how disease states and genetics play a role in patient care and outcomes. Even with the added complications from introducing another data set into clinical trials, we will see more genetic-specific results come from future clinical trials. Genetic screening will help create more effective therapies targeted to the genetic underlying cause of the disease. As clinical trials continue to evolve, we will see the need for more and more gene counselors to help support not only the patients and families involved with the clinical trial, but also in assisting researchers in patient recruitment and retention. Overall, this will lead to targeted therapies and better outcomes.

    Ryan Seeley, facility manager

    Research project managers and coordinators will be able to work in their native language

    With the shortage of clinical research associates (CRAs) and other positions that require working with others globally, losing the need for proficiency in the sponsor’s language could open up new pools of qualified candidates. So much of the communication needed to coordinate the everyday aspects of a clinical trial revolve around status updates and regularly passing along the same type of information.

    Advances in artificial intelligence and its ability to replicate the predictable aspects of human communication (we are far more predictable than people choose to believe) make it possible to someday be able to use localized versions of web portals to check the status of a trial as well as machine translation for the everyday email traffic we currently live in.

    Erica Manning, Imperial operations manager of design, translation, and study closure services

    May 20, 2020 0 comment
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