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Clinical Trials Innovation

The operational challenges facing virtual clinical trials - INDUSTRY VOICES

Virtual trials have been held up as the future of clinical trials for more than five years, but progress has been slower than hoped by many. Challenges remain around data, platforms, logistics and hardware, and there are few case studies of truly fully virtual trials being run. However, their potential remains almost limitless, with virtual trials likely to totally revolutionize clinical studies in the next decade or so.

We asked five industry insiders from every aspect of clinical trials – from a study manager, to a site consultant, to a patient – about what operational challenges they see that still need to be overcome before virtual clinical trials can be fully and effectively implemented.

 

Robert Corbé, Clinical Trial Manager, Isofol Medical, Sweden

“I would like to see more Patient-reported outcome (PRO) questionnaires to be validated for completion on different handheld devices. This would enable the patients to use their computer, laptop, tablet or smartphone when completing the information. Providers of PROs and research organizations should consider this as an important development since it will limit the study impact on the patient’s day to day life in RWE studies. The easier the study is for the patients, the more it will enhance recruitment and provide us with more reliable data.”

Robert Corbé is presenting a case study on ‘How to manage cultural differences, site engagement and patient recruitment when running a global study in a biotech company’ at Clinical Trials Europe on 19 November 2019 in Barcelona.

 

Kate O’Brien, Site Performance Consultant

  • “Who are trials conducted to benefit? At whose convenience are clinical trials carried out?
  • Sites are threatened with a loss of income if data is collected remotely.
  • 37% sites under enrol, 11% fail to enrol anyone, there is a 30% dropout rate (Tufts CSSD)
  • Technological advances lead to changes in working practice for more efficient, cost effective business.
  • Courier services now should encompass delivery and collection of IMP to a patient’s local pharmacy or direct to their home.
  • In 2020 patients should be able to use their own smartphone/tablet to collect data and complete questionnaires at home.
  • So, why is the industry continuing to fund and support poorly performing sites?

Interestingly I would not have been able to write this if I was still employed by a site!”

Kate O’Brien is taking part in a panel on ‘Taking part in a trial - Myths and Reality’ at Clinical Trials Europe on 20 November 2019 in Barcelona.

 

Stuart Kilpatrick, Patient

“Can individuals undertake clinical trials at home with the use of technology? I would be more interested in undertaking clinical trials if an element of it could be done at home. Monitoring my heart rate, blood pressure, blood sugar levels, sleep, diet and exercise patterns, as well as the taking of medication all lend themselves to being undertaken remotely, utilising IT or apps on my phone, with the same results.

This would lessen the impact on my lifestyle, reduce travelling and expense. The time element of some trials puts me off participating especially where numerous attendances or lengthy visits to my doctor are part of the study.

Do drug companies really set up trials for the convenience of themselves, GP practices, or us patients??”

RELATED ARTICLE: How full virtual clinical trials can become reality in the next 10 years

 

Kristi Clark, Senior Vice President, Project Management and Clinical Operation, Precision for Medicine, Oncology & Rare Disease

“Virtual drug and device trials may require data collection through wearable technologies that must be validated for clinical trial use. Many wearable companies realize that health and fitness sales are much more lucrative than the clinical trial market and therefore they do no validate their technology for trials. Additionally, baseline and end of study physical examinations are part of the schedule of events. Validation of video examinations along with wearable data collection tools could replace the need for physical examinations by an onsite clinician. If samples are required, such as PK, this can be solved by providing home healthcare services.”

 

Dr Richard Stephens, Chair of the BBMRI-ERIC Stakeholder Forum and formerly Chair of the National Cancer Research Institute (NCRI) Consumer Forum

“As a cancer and heart patient I am not convinced about virtual trials. I can see the appeal for PROMs and for a long-overdue revision of QoL tools (EQ5D was introduced in 1990; medicine has moved on), but evidently virtual trials won’t work for any study that requires a major scan or for surgery.

However as someone also suffering from other morbidities, I can certainly see the advantages of virtual trials for chronic conditions, and for anything seeking real-time monitoring. But many of the advantages for patients – PROMs, real-time evidence, rethinking our QoL tools – and some newer innovations such as clinical reporting and clinical alerts (eg home blood tests, cardiac monitoring etc) can all be achieved by making better use of new technologies and new approaches in existing trials.

I’d add diagnostics to the possibilities too; especially if we ever get to reliable blood tests for cancer.

One thing though, and that’s the name. No trial is a virtual trial if you are a patient on it. The trial, and the disease or condition, are very real.”

Dr Stephens is speaking on ‘How do you build up Trust - do patients trust industry and does industry trust patients?’ at Clinical Trials Europe on 21 November 2019 in Barcelona.

 

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