by Steve Moscoe

Telehealth and remote patient care is one such approach. Here’s what to consider as you bring your trials into the modern era.

Bringing a new drug, medical device, cell or gene therapy to market is a very expensive investment. Costs can range from hundreds of millions of dollars to several billion dollars – and are only increasing every year. Though treatments are improving, the outcomes for patients, especially those with serious or rare illnesses, and the efficiency of R&D are decreasing, as measured in time and investment to bring new drugs to market. Though there are many contributing factors, the time and costs associated with clinical trials are key factors.

There are numerous challenges associated with traditional clinical trials, including failure to recruit enough patients and the diversity of those patients for each site study; abandonment of the study by patients for health, logistical, and cost reasons; and study management by the individual sites. Adding to these challenges are cost pressures, the global pandemic and the desire to improve the patient experience, which put pressure on life science companies to explore alternative methods for conducting clinical trials.

Telehealth and the move to Decentralized Clinical Trials (DCTs) with the use of Remote Patient Monitoring (RPM) is a possible solution for these challenges. DCTs have the potential to be more cost efficient, effective and timely. Regulators around the world are increasingly weighing in on the need for clinical trial modernization and digitalization, which can lead to better trial designs, patient selection, methods for assessing a treatment’s efficacy and adoption of new technologies.

Enabling Decentralized Clinical Trials

DCTs are not a new concept, but the ability to manage them more effectively through the use of technology is a recent phenomenon.  While regulators were already warming to the idea, the COVID-19 pandemic interrupted so many traditional trials that there was a call from the life sciences industry, disease advocacy groups, regulators, providers and patients to determine ways to restart existing trials and manage future trials remotely.

Enter DCTs, the “rising stars” in this environment. Clinical Trial Management Systems (CTMS), a foundation for DCTs, have been around for some time as part of the digitalization of the research and development systems environment. Decentralized CTMS (dCTMS) software is designed to be more nimble for non-site specific trials, often combining several or all qualities of a trial including:

  • Patient recruiting, enrollment, e-consent and patient management
  • Randomization of patients
  • Trial supply management
  • Data capture from patient and clinical reported outcomes
  • Interaction with patient monitoring, lab and provider systems
  • Analytics that support trial disposition

Expanding Remote Patient Monitoring

Consumer gadgets and medical devices that can measure your pulse, blood pressure and other simple observations have been around for decades and are now available to patients. With the processing power, miniaturization, and invention of sensors that can detect a variety of possible observations, e.g., blood glucose, blood oxygen saturation, etc., Remote Patient Monitoring (RPM) has vastly increased the capabilities to collect data relevant to patients, providers, life science companies and payers.  Additionally, that data can be integrated into providers’ Electronic Health Records (EHR) systems to provide seamless information about the distributed treatment of patients, particularly those with chronic diseases.

Examples of RPM in use at life science organizations include:

  • Decentralized clinical trial patient and clinician observed outcomes
  • Co-consultation of life sciences professionals with providers for improved patient outcomes
  • Population monitoring for pharmacovigilance and long-term post-launch studies

Patient experience has been measured to be much improved with the use of RPM, when coupled with adequate training and appropriate interaction with providers. While there are still procedures, such as blood draws, that require a lab, trial site, or provider visit, the frequency in which a patient leaves their home or care facility is greatly reduced. When coupled with DCT technology and trial management, RPM can be transformative in terms of the patient experience and cost reduction for both life sciences organizations and patients alike.

If you’re exploring the move to DCTs with RPM, be sure to consider the following as a starting point:

  • Identify the DCT needs. The rationale for all clinical trials is not the same. A trial for a biosimilar drug, a new medical implant and a new cell therapy are all very different cases with different trial management and patient needs.
  • Determine the scope of the change. The tools, processes, and organization’s needs depend on the scope.  Some systems can handle the randomization of the study, patient enrollment, data collection and feedback about the patient and treatment results, as well as the trial supply management. Be sure to consider the patient experience, keeping patient outcomes and experience top of mind.
  • Assess your partners. If you are considering using non-clinical trial partners to collect data about patients, e.g., general practitioners and lab collection centers local to the patient, think about how those collaborators will work with your organization, and how they will drive some of the requirements for DCT processes, systems and trial management organization.

Summary

Whatever challenges the world of research may throw at life sciences organizations, provider, payers, and patients, DCTs and RPMs can reduce costs and improve patient and study outcomes. The key is to rethink how clinical research is conducted. Point B can help, while keeping the patient experience the focus.