COVID-19 accelerates a paradigm shift in clinical trial innovations from protracted conjecture:
Over 1,200 clinical studies globally suffered from COVID-19’s unfavorable effects between March and November of 2020. Some were totally shut down, while others had lockdowns, patients who were unwilling to continue a trial, or a variety of other pandemic-related setbacks. In order to keep things moving forward, COVID-19 has required adaptability, innovation, and creative solutions, just as in every other area of life. As a result, a long-discussed but little-used innovation approach for clinical trials was extensively adopted for survival reasons.
Decentralized trials (DCT) have been discussed for at least ten years, but before COVID, there was a general reluctance to embrace them as standard procedures. Consider the fact that only 38% of pharma and CROs responded to a 2019 poll by Industry Standards Reports on their plans for virtual trials, and only 48% said that most participant activities will be carried out from their homes.
When McKinsey and Company asked the same question in 2020, virtual experiments were expected to be in 100% of respondents’ wallets, and nearly 90% of those surveyed said experiments would be conducted through activities conducted from the participants’ homes. Familiarity is that when it comes to pushing, people are more willing to make innovative changes, and the majority of investigators now anticipate a strong adoption of DCT.
According to a survey by Informa Pharma Intelligence and Oracle on the life sciences industry, 84% of respondents innovate specific approaches such as remote monitoring, video and phone visits, eConsent, and electronic medical records (EHR), which are most often used during pandemics. Did. In retrospect, 82% said the new methods had a positive impact on the trial, and 97% said that at least one of these new methods stayed here and recruited online patients on the list of most likely new DCT recruitments. Said to add. Even at best, it is widely estimated that enrollment delays 80% of clinical trials, 48% of sites fail to meet enrollment goals, and 70% of patients are more than 2 hours away from clinical sites. These types of changes have long been postponed to make clinical trials more efficient and cost-effective.
DCT’s numerous advantages can now be more fully appreciated:
Although the potential advantages had long been acknowledged, it took the epidemic to bring these improvements into broad use. With the advancements in DCT trials, researchers may now start to observe:
Increased accessibility to a more varied patient base and a wider range of patient options:
(In response to an Oracle survey, 58% of respondents stated that they would allow patients to choose their level of trial participation and that this would have a beneficial effect on clinical trials.) Reaching out beyond the typical travel distance between clinics can increase the number of patients who can participate and will increase the power of clinical research to benefit additional demographic groups.
Improved real-world data that is timely and more retained:
Patients participating in trials remotely will do so for a longer period of time and provide more precise, individualized information, including information on the quality of life. When caregivers are relieved of the responsibility of making travel arrangements to clinics, they are also more inclined to promote compliance. (According to the Oracle poll, 92% of participants expressed confidence in the accuracy of data gathered using the new techniques compared to data gathered before the epidemic.)
Streamlined operations:
Due to the fact that telehealth visits can be up to 50% less expensive than in-person visits, investigators may be able to cut workloads with a better cost model. DCT innovations can ease pressures on sites and even reduce the number of sites required, as some sites already have staff shortages and others report that people who are used to working remotely want to keep doing so.
Increased opportunities for patient involvement:
Digital communications will make it possible for existing and potential participants to communicate more often with more stakeholders, both before and after making a decision to engage. Effective use of technology can enhance the “human touch” experience.
Adaptability in crisis situations:
Clinical trial design can become more flexible and agile by including DCT aspects. The COVID-19 incident served as a worldwide reminder of how disasters can interfere with and potentially endanger clinical trial procedures. There will be less disturbance during upcoming catastrophes as the standard for trials moves toward decentralization and digitization.
Promoting medical research as a form of treatment:
The DCT concept can assist in bringing clinical research closer to patients’ homes and toward a practical healthcare option where clinical trials are used to treat eligible individuals. Not only will patients and their doctors gain greatly from this, but also the clinical research community as a whole.
To overcome challenges, DCT needs upfront planning and investment:
There are challenges to making the DCT concept a norm, despite the fact that it was swiftly adopted as a pandemic response. Complex digital transitions call for advance planning, funding, training, and explicitly defined metrics for gauging success as new procedures are put into practice. To ensure that virtual components are strategically integrated and will actually offer value to the trial and the patient, they should be considered carefully from the beginning of the trial design.
Assuring a safe and reliable digital infrastructure, quality control of data, privacy issues, compliance with current legal standards, cultural issues, appropriate training for investigators, and patient digital literacy can all be barriers to adoption. The organization must also be prepared to manage change in all areas of its operations.
Naturally, not all clinical trial processes can be virtualized. Traditional operations will still be needed for complicated procedures, numerous examinations, and screenings. However, even Phase III trials are reporting the use of a mixed format with some degree of decentralization.
Industry development – governments and regulators react to big tech quickly:
As a result of the pandemic, authorities and governments had to update their regulations to accommodate the need for clinical research. Official guidelines supporting cutting-edge technological approaches were published by the US FDA, European authorities, and Japanese regulators. With Stanford and Google already working together on a platform that arranges clinical trial participation depending on a patient’s unique schedule, Apple and Google are making significant investments in tools to enable DCT.
The clinical trial market is seeing the emergence of new companies and strategic alliances. Companies with significant internet presences, including CVS and Amazon, are launching initiatives that can swiftly adapt to widespread patient involvement in some trial processes. These kinds of cross-industry collaborations will advance and be incorporated into the clinical research model of the future.
Clinical trials and their management will need to be flexible and adaptable in a new environment that is being driven by both global medical emergencies and quickly developing technologies as the landscape of healthcare continues to change.
At George Clinical, we’ve always pushed for innovation and patient care in our overarching concept as well as in any particular experiment. These new paradigms lend themselves perfectly to our scientific leadership methodology. In order to ensure that the greatest treatments are quickly put into clinical practice for patients around the world, our global thought leaders—who are influential researchers as well as clinicians—will continue to collaborate.
COVID-19 accelerates a paradigm shift in clinical trial innovations from protracted conjecture:
Over 1,200 clinical studies globally suffered from COVID-19’s unfavorable effects between March and November of 2020. Some were totally shut down, while others had lockdowns, patients who were unwilling to continue a trial, or a variety of other pandemic-related setbacks. In order to keep things moving forward, COVID-19 has required adaptability, innovation, and creative solutions, just as in every other area of life. As a result, a long-discussed but little-used innovation approach for clinical trials was extensively adopted for survival reasons.
Decentralized trials (DCT) have been discussed for at least ten years, but before COVID, there was a general reluctance to embrace them as standard procedures. Consider the fact that only 38% of pharma and CROs responded to a 2019 poll by Industry Standards Reports on their plans for virtual trials, and only 48% said that most participant activities will be carried out from their homes.
When McKinsey and Company asked the same question in 2020, virtual experiments were expected to be in 100% of respondents’ wallets, and nearly 90% of those surveyed said experiments would be conducted through activities conducted from the participants’ homes. Familiarity is that when it comes to pushing, people are more willing to make innovative changes, and the majority of investigators now anticipate a strong adoption of DCT.
According to a survey by Informa Pharma Intelligence and Oracle on the life sciences industry, 84% of respondents innovate specific approaches such as remote monitoring, video and phone visits, eConsent, and electronic medical records (EHR), which are most often used during pandemics. Did. In retrospect, 82% said the new methods had a positive impact on the trial, and 97% said that at least one of these new methods stayed here and recruited online patients on the list of most likely new DCT recruitments. Said to add. Even at best, it is widely estimated that enrollment delays 80% of clinical trials, 48% of sites fail to meet enrollment goals, and 70% of patients are more than 2 hours away from clinical sites. These types of changes have long been postponed to make clinical trials more efficient and cost-effective.
DCT’s numerous advantages can now be more fully appreciated:
Although the potential advantages had long been acknowledged, it took the epidemic to bring these improvements into broad use. With the advancements in DCT trials, researchers may now start to observe:
Increased accessibility to a more varied patient base and a wider range of patient options:
(In response to an Oracle survey, 58% of respondents stated that they would allow patients to choose their level of trial participation and that this would have a beneficial effect on clinical trials.) Reaching out beyond the typical travel distance between clinics can increase the number of patients who can participate and will increase the power of clinical research to benefit additional demographic groups.
Improved real-world data that is timely and more retained:
Patients participating in trials remotely will do so for a longer period of time and provide more precise, individualized information, including information on the quality of life. When caregivers are relieved of the responsibility of making travel arrangements to clinics, they are also more inclined to promote compliance. (According to the Oracle poll, 92% of participants expressed confidence in the accuracy of data gathered using the new techniques compared to data gathered before the epidemic.)
Streamlined operations:
Due to the fact that telehealth visits can be up to 50% less expensive than in-person visits, investigators may be able to cut workloads with a better cost model. DCT innovations can ease pressures on sites and even reduce the number of sites required, as some sites already have staff shortages and others report that people who are used to working remotely want to keep doing so.
Increased opportunities for patient involvement:
Digital communications will make it possible for existing and potential participants to communicate more often with more stakeholders, both before and after making a decision to engage. Effective use of technology can enhance the “human touch” experience.
Adaptability in crisis situations:
Clinical trial design can become more flexible and agile by including DCT aspects. The COVID-19 incident served as a worldwide reminder of how disasters can interfere with and potentially endanger clinical trial procedures. There will be less disturbance during upcoming catastrophes as the standard for trials moves toward decentralization and digitization.
Promoting medical research as a form of treatment:
The DCT concept can assist in bringing clinical research closer to patients’ homes and toward a practical healthcare option where clinical trials are used to treat eligible individuals. Not only will patients and their doctors gain greatly from this, but also the clinical research community as a whole.
To overcome challenges, DCT needs upfront planning and investment:
There are challenges to making the DCT concept a norm, despite the fact that it was swiftly adopted as a pandemic response. Complex digital transitions call for advance planning, funding, training, and explicitly defined metrics for gauging success as new procedures are put into practice. To ensure that virtual components are strategically integrated and will actually offer value to the trial and the patient, they should be considered carefully from the beginning of the trial design.
Assuring a safe and reliable digital infrastructure, quality control of data, privacy issues, compliance with current legal standards, cultural issues, appropriate training for investigators, and patient digital literacy can all be barriers to adoption. The organization must also be prepared to manage change in all areas of its operations.
Naturally, not all clinical trial processes can be virtualized. Traditional operations will still be needed for complicated procedures, numerous examinations, and screenings. However, even Phase III trials are reporting the use of a mixed format with some degree of decentralization.
Industry development – governments and regulators react to big tech quickly:
As a result of the pandemic, authorities and governments had to update their regulations to accommodate the need for clinical research. Official guidelines supporting cutting-edge technological approaches were published by the US FDA, European authorities, and Japanese regulators. With Stanford and Google already working together on a platform that arranges clinical trial participation depending on a patient’s unique schedule, Apple and Google are making significant investments in tools to enable DCT.
The clinical trial market is seeing the emergence of new companies and strategic alliances. Companies with significant internet presences, including CVS and Amazon, are launching initiatives that can swiftly adapt to widespread patient involvement in some trial processes. These kinds of cross-industry collaborations will advance and be incorporated into the clinical research model of the future.
Clinical trials and their management will need to be flexible and adaptable in a new environment that is being driven by both global medical emergencies and quickly developing technologies as the landscape of healthcare continues to change.
At George Clinical, we’ve always pushed for innovation and patient care in our overarching concept as well as in any particular experiment. These new paradigms lend themselves perfectly to our scientific leadership methodology. In order to ensure that the greatest treatments are quickly put into clinical practice for patients around the world, our global thought leaders—who are influential researchers as well as clinicians—will continue to collaborate.
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