Clinical trial continuity is a MUST to help facilitate new drug development. With the evolution of the global COVID-19 pandemic situation, a large percentage of clinical trial professionals have engaged in virtual or hybrid clinical trial models versus traditional clinical trial models.
While many clinical trials are being augmented to meet the needs of both patients and pharmaceutical companies, the long-term viability has many unanswered questions. As such, industry stakeholders are rapidly exploring avenues to help bring ease and quick response to the challenges seen with the forced early adoption.
The benefits of transitioning to a virtual clinical trial model versus a traditional clinical model are many with only a few downsides for both the stakeholder and the patients.
The challenges associated with remote clinical trials include:
Ways to continue patient engagement standards
Adherence to patient-participation objectives
Staying on track to meet trial completion dates
Adverse reactions and reporting
Vulnerable populations such as elderly, children, and non-English speakers
The solutions are actively being met through enhanced remote capturing tools and software. The major benefits are expanded upon below for further consideration:
Data Capture Proficiency
The ability to capture data in real time is an added plus to remote monitoring. The complexities of navigating contracts, adverse reporting, recruitment, remote management, and EMR all rest neatly in arms of sophisticated technology.
Pharmaceutical companies want both patient-centric practices and clinical monitoring expertise harnessed into one product, and that is now obtainable by partnering with strategic providers.
Virtual data capturing involves end-to-end remote device management and should include factors such as:
Easy-to-navigate qualitative tools
Adaptation for patient use
How physicians administer care
Interpretation of field data to incorporate into data-capturing solutions
This comes down to being able to merge data mining capabilities alongside otherwise missing data points. Data integration software can plug-in environmental factors, EMR, and patient reporting in real-time. This gives stakeholders the ability to leverage data capturing at the highest level of accuracy possible.
Patient and Treatment Experience
Most patients really appreciate participating remotely. It provides a layer of convenience otherwise not able to be achieved. They don’t have to worry about transportation and other hindrances associated with obtaining trial data. Statistics reveal improved patient experience overall and adherence to trial objectives.
COVID-19 came and threatened the ability to continue clinical trials. Quick adaptation methods were created to help keep them active and credible.
Data-driven tools such as social media, AI, and remote patient monitoring are proving to be not only working but working better than anticipated. Trial continuity hinges on technology but also rests firmly on flexibility.
Other important aspects of trial continuity may depend upon other variables such as:
Care during treatment
External issues (i.e. power, internet, and remote devices)
Addressing these concerns can be accomplished through the help of in-home aids or nursing, direct patient contact, and safeguarding home environments with adequate supplies and power sources.
Clinical trials can cost up to millions of dollars and can span up to a decade to complete. The average cost per patient participant is stated to be approximately $41, 117 according to a report submitted to the U. S. Department of Health and Human Services. A recent article put out by John Hopkins University cited the average cost of new drug development can range between $2-3 billion dollars.
Virtual clinical trials help to reduce the average cost of bringing a drug to market by:
Shorter enrollment periods
Reduction of trial drop-out rates
Expedited data collection and accuracy
Reduction of investigator fees
Streamlining patient visits
Reduced need for onsite management
Ability to Reach More Diverse Patient Populations
Underrepresentation of minority groups in clinical trials is taking center stage and the FDA issued a guidance document to help narrow the gap. The consensus is to improve those statistics through the help of both technology and expanded eligibility criteria. The limitations provided by logistics and generalized burden to participants are greatly lifted by going virtual thereby helping to provide a bridge for both services and monitoring convenience.
The Future Outlook of Virtual Clinical Trials
Without question, it is safe to assume the future lies with the continuance of virtual clinical trials and recruitment. We can look forward to the advancement of more sophisticated tools and devices and this will help to streamline the process for major stakeholders. Early data suggests we are at looking at about an 83% total adoption rate to either virtual or hybrid trial models at the time of this writing. This suggests the acknowledgment of the major benefits such as cost-cutting factors as an accelerant aside from the necessities provided by the COVID-19 pandemic.