By |2020-09-15T21:43:40+00:00September 15th, 2020|Uncategorized|0 Comments

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 are currently 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 clinical trial virtual trial model versus a traditional clinical model are many with 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
  • Recruitment
  • Adverse reactions and reporting
  • Accuracy
  • Vulnerable populations such as elderly, children, and non-English speakers
  • Trial credibility
  • Privacy concerns

The solutions are actively being met through enhanced remote capturing tools and software. The major benefits are expanded upon below for further dissection:

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 cloud computing, easy-to-navigate qualitative tools, and adaptation for patient use. Additionally, virtual-reality devices help augment the choices for how physicians administer care and interpret field-data to incorporate into data-capturing solutions.

Disparate Data

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 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.

Trial Continuity

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 training, care during treatment, and external issues (i.e. power, internet, and remote devices). Addressing these concerns can be accomplished through the help of in-home aids/nursing, direct patient-contact, and safeguarding home environments with adequate supplies and power sources.

Cost Reduction

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.

 

Further Reading
1. https://www.ncbi.nlm.nih.gov/books/NBK50888/
2. https://mhealthintelligence.com/news/mobile-device-data-capture-effective-in-clinical-trials
3. https://www.clinicaltrialsarena.com/analysis/virtual-clinical-trials-covid-19/
4. https://www.nature.com/articles/d41586-019-02871-3
5. https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.119.040798
6. https://medcitynews.com/2019/04/leveraging-technology-and-digital-tools-to-finally-increase-diversity-in-clinical-trials/?rf=1
7. https://mhealthintelligence.com/news/mobile-device-data-capture-effective-in-clinical-trials
8. https://www.ncbi.nlm.nih.gov/books/NBK441694/