The Patient-Centric Future of Clinical Research Trials

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As the pressure grows for pharmaceutical researchers to deliver robust clinical results faster, without increasing costs, compromising on data quality, or risking patient safety, traditional trial models aren’t providing the level of patient-centricity the industry demands.


Key terms explained:

  • Patient-centricity: Reducing the burden on study participants by giving them extra support or adapting the way trials are run
  • Virtual clinical trials: Studies that are conducted remotely using a combination of technologies, rather than on-site
  • Travel management company: Some researchers are outsourcing patient transport, accommodation and other services to end-to-end suppliers

The Life Sciences industry is carrying out some of the most vital research in the world – but there’s now evidence to suggest that some of its methods are becoming outdated.

For pharmaceutical companies and clinical research organisations, the ever-increasing focus on improving trial outcomes and data quality, combined with growing demand for more diverse research, means that across the board, emphasis is shifting from volume to value.

Patient experiences lie at the heart of great, quality research. If providers want to meet demand for higher-quality, higher-value research, they need to work on making their processes and trials more patient-centric.

The key to patient-centricity for clinical research is reducing patient burden – by increasing convenience and accessibility – but traditional trial models often don’t provide the structure or support researchers need to make that happen.

We’ve been looking into the changing environment of clinical research. Here are some of our thoughts on what achieving patient-centricity will look like – and some insights to help you adapt your own trial models.

Demand for healthcare and medication is growing

Clinical research is a growth industry, largely driven by an ageing global population that’s living longer, but with more chronic illnesses that require treating.

The UN’s recent World Population Prospects report predicts that the global elderly population will more than double in the next 30 years or so. By 2050, it’s anticipated there will be more than 2.1 billion over-60s – up from 962 million in 2017.

Research also indicates that people are now more likely to live with chronic health conditions – and that will put yet more pressure on long-term healthcare delivery. The World Health Organisation is expecting these chronic ailments to account for 60% of the global burden of disease by the end of 2020.

And with 70% of chronically ill patients being over 60, their long-term care requirements are increasing demand for affordable alternatives to hospital stays. In turn, this is driving growth in home healthcare, further enabled by technological advancements. With an estimated CAGR of 8.8%, the global home healthcare market is predicted to reach almost $365 billion by 2022.

Technological advances and the rise of home healthcare providers are creating new opportunities to decentralise research, by shifting aspects of trials away from a central site, and build entirely new research processes. Whether researchers want to improve their current processes, or explore decentralisation, one thing is clear – low-burden, patient-centric processes will be key to their success.

Reducing participant burden to increase patient-centricity

In a patient-centric research model, many established clinical trial processes simply won’t work. Patient recruitment, for example, previously relied on physicians’ recommendations and pharmaceutical companies advertising on television or radio – but as many as 80% of studies don’t even get past this initial recruitment stage.[1]

Now, we’re seeing more and more research co-ordinators turning to social media, websites, and mobile apps to find participants.[2] Big players including AstraZeneca, Sanofi and Bayer are already using dedicated patient recruitment companies to achieve this, too.

Specialist vendors such as AutoCruitment, MDConnect and Clinpal recruit participants through tech-based engagement platforms, using data and analytics to identify suitable patients. It’s faster and easier, which reduces trial delays – one of the costliest setbacks.

After recruitment, the most important challenge for research co-ordinators is ensuring participants stay in the study until the end – estimates say as many as a third of people drop out before a trial is complete.[3] But when protocols put too much of a burden on patients, that can become incredibly difficult. With a range of factors – from distance to expense – preventing participants from being able to continue, the industry is starting to adopt more patient-centric practices here, too.

Increasingly, researchers are offering transport to participants, making it easier to attend the on-site components of a study. Some are even outsourcing to travel management companies to reduce the overall burden on co-ordinators and participants alike. A recent study found that 44% of clinical trial sites offer transport assistance, with 58% of them relying on taxis.[4] However, this can get expensive quickly, so analysts are also expecting more sites to make use of ride-hailing services such as Uber and Lyft, or dedicated transport providers with bulk discounts, to manage costs.[5]

Many are also building a more complete support system for their participants, offering patient stipends, childcare, temporary accommodation, and even relocation services.[6] Though these services will add to operational costs, they will help prevent drop-outs, which means researchers can afford the significant outlay for recruiting new participants.

And it’s not just cost savings that make this approach worth considering. As an estimated 40% of participants leave trials in Phase III due to issues such as transport[7], it will also have a major impact on the continuity of clinical research studies. Losing participants so late in a trial can seriously affect data quality, so reducing drop-outs can increase the robustness of results.

The virtual future of clinical research: 4 factors to consider

For some researchers, a more patient-centric model of conducting trials will involve as little on-site commitment as possible. It’s becoming easier than ever to hold virtual clinical trials (VCTs), that use technology and home care provisions to manage site-less research.

According to estimates, it can cost as much as $1.3 billion to run a traditional FDA-compliant study from start to finish[8] – but as demand grows, that simply isn’t sustainable. VCTs will enable many researchers to do away with physical sites entirely during Phase II and III of trials, without negatively affecting data quality or patient safety. Research indicates that VCTs can be up to 50% cheaper to run.[9]

There are four key considerations for designing a VCT:

1. Do you have a home healthcare provider?

Currently, home healthcare services are used in less than 1% of clinical trials. However, for a VCT, it’ll be vital to enable site-less monitoring of patient progress.

These services can handle everything from sample collection and drug administration to clinical assessments and on-call nursing, and manage medical devices such as ECGs. This dramatically reduces patient burden, but will likely require researchers to make long-term arrangements with providers – as currently home care is usually employed on an ad-hoc basis.

2. Are you using the right technologies?

Wearable technologies, remote monitoring devices and user-friendly patient engagement platforms are all key ways to help VCT participants feel more in control. Providing devices that patients can use themselves means researchers can collect more detailed real-time data without site visits, and reach a wider and more representative participant pool without adding to patient burden. The Association of Clinical Research Organisations has highlighted wearables as a leading trend in pharmaceutical research[10], and already partnerships between companies such as Pfizer and IBM are cropping up as more researchers experiment with mobile devices and sensors.

3. Can you keep attrition rates down?

Because of the more detached nature of VCTs, there can be a higher risk of attrition – which means you’ll need to pay closer attention to delivering consistent, frequent engagement and incentivisation to keep participants on board. GSK, for example, recently ran a feasibility study that used daily updates to encourage long-term engagement from rheumatoid arthritis patients.[11]

4. Is your study still safe and compliant?

It’s also vital to ensure VCTs are compliant with all the necessary regulations, wherever your participants are, and have a stringent data protection strategy in place. Some researchers are using end-to-end VCT providers that include these services within their offering. There aren’t many of these providers in the space yet – examples include Science 37 and Medpoint – but we expect the number of players in the market to grow as VCTs become more defined and popular.

Looking ahead

The need for robust, high-quality clinical research data grows greater each day. Whether researchers want to improve existing processes, or design entirely new ones using connected technology and in-home care delivery, increasing the patient-centricity of studies is essential.

Many programmes aimed at increasing patient-centricity are in the pilot stage, and their success will likely dictate the direction of the market as a whole. The industry’s leaders will be watching closely to see how these initiatives pan out before committing to large-scale shifts in their own organisations.

 

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We work with life sciences organisations across the spectrum and get to witness the ongoing transformations taking place. Here you can read our perspectives on what 2019 might have in store for the sector.

 

[1] ‘The Evolution Of The ‘Site-less’ CRO And Why We Need It’, CenterPoint (November 2016)

[2] ‘Big Data Technologies Penetrate Patient Recruitment and Enrollment: Interview with TrialReach’, Applied Clinical Trials (June 2015)

[3] ‘Benefits of Outsourcing Clinical Trials Travel Management’, EQ Travel (September 2016)

[4] ‘Survey: Ridesharing is on the rise for clinical trials’, CenterWatch (June 2017)

[5] ‘Survey: Ridesharing is on the rise for clinical trials’, CenterWatch (June 2017)

[6] ‘10 Services Your Clinical Trial Travel Manager Should Provide’, EQ Travel (August 2017)

[7] ‘The Evolution Of The ‘Site-less’ CRO And Why We Need It’, CenterPoint (November 2016)

[8] ‘Virtual Clinical Trials Landscape’, GEP (October 2016)

[9] ‘The Evolution Of The ‘Site-less’ CRO And Why We Need It’, CenterPoint (November 2016)

[10] ‘Survey: Ridesharing is on the rise for clinical trials’, CenterWatch (June 2017)

[11] ‘What GlaxoSmithKline Learned From Their Digital Trial of Rheumatoid Arthritis’, Clinical Informatics News (March 2018)

 

 

Bhavye Aggarwal

Bhavye Aggarwal

In his four years with The Smart Cube, Bhavye has risen through the ranks from an analyst to currently an Assistant Manager in the Life Sciences Unit. He has helped clients in the Life Sciences sector in market entry-strategy formulation, market assessment, target customer identification, competitor/supplier/potential client bench-marking, and market intelligence. Bhavye is a co-author of research article, "A Network Biology Approach to Decipher Stress Response in Bacteria Using Escherichia coli As a Model (May 2016, Mary Ann Liebert, Inc. Publishers)." Outside work, Bhavye likes to spend his time reading, exploring the art of cinema and new cultures around the world.

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