So many things have changed as a result of the Covid-19 pandemic. Things we took for granted have become difficult or even impossible as the world seeks to accommodate the changes society has had to make to contain this deadly virus. One of the most challenging changes has been those wrought upon the process of discovering new medicines. Clinical trials are an integral part of bringing cutting-edge science to the patient and afford countless people suffering from the disease a valuable opportunity to take part in the testing of new medicines. However, lockdowns and travel restrictions across the world have completely changed the environment within which medical research is conducted and so organizations have had to adapt to continue progress against the disease.
The Global Life Science Alliance (GLSA) has observed closely these changes as they have developed over the past year and we strongly believe our clients are very well placed to help clinical trial study sponsors and CROs.
Equipped for remote patient monitoring
Like much of the activity we once blithely conducted at large, the physical location of much of clinical trial-based activity has shifted to the home. This necessitates the employment of digital platforms and devices that allow clinical research to continue in the houses of patients. A new digital platform such as Tryl allows patients to remain engaged without having to attend outpatient centers. Having well-designed, user-intuitive digital interventions will be key to sustaining high quality and volume of clinical research in our new reality.
Connectivity will also be key. These new digital platforms rely on a range of home-use medical dev
ices such as electrocardiograms, blood pressure monitors, scales, and pulse oximeters that are largely wireless. This requires synchronization of a range of complementary devices that are robust yet cost-effective for the sponsors and CROs. Bringing this IoT environment under control is the focus of Kore Wireless who can negotiate preferential data contracts, source medical peripherals, and coordinate the entire range of IoT-connected devices to make home-based, decentralized clinical trials a practical reality.
Digitized and auditable
The adaptations we are making to allow this new era of clinical trials to be possible requires an enormous wave of digital technology to be employed. Shifting from paper-based, ad hoc systems to better organized, accountable and auditable systems is a key driver for success in this changing Industry. From the recording of patient data to the ultimate oversight of the trial conduct and safety, all elements are ripe for digital efficiency. An ele
gant exemplification of this is the approach The Concinnity Company has taken to streamline the activities of Data Monitoring and Safety Boards. By designing an intuitive digital platform The Concinnity Company DSMB/DMC solution harnesses the knowledge, wisdom, and experience of a carefully selected clinical trial oversight board and makes it efficient, streamlined, real-time, and more effective at ensuring clinical trials are conducted safely and effectively to the benefit of patients.
With efficiency also comes a responsibility to reduce the environmental burden of clinical trials. The e
nd of physical paper trails not only eases the pressure on a planet under stress but also leads to increased efficiency and easier auditing. DocuTrial’s approach to making all clinical trial focused documentation digital confers a range of advantages to clinical trial sites as they seek to adapt to the changing clinical research environment. Allowing trial sites to operate more efficiently by saving space, time, and paper whilst creating a more manageable and secure data infrastructure.
Trial design
All these changes also mean that trials have to be designed accordingly, maintaining a high level of integrity but adapting to the additional procedural burden of decentralized trials. At Inference biometrics and biostatistics are integrated with a consideration of data management and pharmacokinetics to enable a trial design to accommodate the changing needs of remote patient monitoring and decentralized clinical trials.
Keeping standards high
There are, of course, other considerations that could compromise the quality and ultimate success of a clinical trial. In many long-term, chronic conditions such as pain, neurodegenerative or psychiatric conditions due to the nature of these diseases patients often enroll for more than one clinical trial. This practice is actually detrimental to the integrity of clinical trials causing data duplication and potentially undermining the whole trial. GLSA client company Verified Clinical Trials have the most comprehensive register of patients available to sponsors and CRO, allowing those recruiting for clinical trials to be secure that their patients aren’t on other medication in other trials and that there is no duplication in recruitment.
At GLSA we monitor clinical trial practice and trends closely, understanding who is currently providing the best value, smartest technology, and highest service standards to sponsors and CROs. If you would like to arrange a discussion to better understand the service and technology environment or would like to increase the exposure of your clinical trial technology to the clinical trial community, please reach and out and we’d be delighted to discuss how we can drive your business to achieve maximum impact for the patient.