The last year has been a big one for clinical research. As of December 2017, there were 261,469 active registered clinical trials across the world.[i] Of these, almost half are drug or biological trials (123,806), with 45,501 currently recruiting participants. Last year an incredible 29,350 studies posted results – that’s an increase of over 1,400% in under a decade.
It’s impossible to make accurate predictions for the coming year, but one thing we can know with some certainty is that the number of clinical trials will increase. However, that doesn’t necessarily mean we will see more drugs and treatments, as failure rates of trials are unfortunately still high, hovering around 70% for Phase II trials, and at 50% for Phase III trials.[ii]
In this article we review five significant developments in clinical trial trends and what these mean for you, your trial and your organisation
1) The rise of patient-centric practices
The concept of patient-centric clinical trials - where the participants are active collaborators in the trial and not merely the subject – is nothing new. However, genuine patient-centric trial practice is now really taking a step forward.[iii]
The increasing profile of the 2017 Bioethics Scorecard shows how transparency is becoming a key measure for pharmaceutical trials. The scorecard ranks companies and new drugs on patient-centric issues and ethics. Johnson & Johnson and Sanofi are tied at the top, with 100% transparency, with AbbVie, Celgene and Merck rounding out the top 5.[iv]
The major pharmaceutical companies like GSK, Pfizer and Bayer have continued to promote patient centricity, finding new and innovative ways to engage and inform patients. This is a trend that’s not going away.[v]
What does this mean in the future?
Patient centricity isn’t just about transparency. The tailored approach is also being used to increase participation in clinical trials. The recent $11m investment into Antidote Technologies clinical trials matching platform reflects the changing nature of patient recruitment, and a reflection of the need to become more responsive.[vi]
In 2017 the industry made a definite shift toward ensuring that clinical trial participation better reflects our society, with organisations like the FDA pushing for greater diversity in clinical trials. The importance of diversity and representation in trials will continue to be a key issue for the rest of 2018.[viii]
2) eHealth and data sharing across the EU
The increasing focus on transparency of clinical trials for patients has been matched by a commitment to the security of information. Those in Europe engaged in clinical trials are readying themselves for the introduction of the new EU Clinical Trials Regulation in 2019. They’re also now adjusting to the impacts of the General Data Protection Regulation, introduced in May 2018.[ix]
As well as the regulatory challenges, developments like the European Medicines Agency’s Clinical Data website are increasing the greater transparency of data across the research community.
What does this mean for the future?
The increase in regulation and scrutiny will inevitably add additional challenges to those conducting clinical trials.
Making data more free and open is a trend we will see accelerate, with details of the European Science Cloud becoming much clearer.[x] The shift to open data will continue in the private sphere too, with the growth of the Clinical Study Data Request platform likely to continue in the coming year.[xi]
3) mHealth and Wearable Tech
We’re still not at the stage where wearable technologies are widely accepted for clinical trials, but there have been significant steps taken as legislators focused on tackling the current lack of regulatory guidance for their use.[xii]
In July 2017, the Center for Devices and Radiologic Health in the USA released its Digital Health Innovation Action Plan committing it to follows from the European Commission’s Smart Wearables paper that discusses similar issues. It’s only a matter of time before they start to be used.[xiii]
What does this mean for the future?
The use of wearables in clinical trials is in its embryonic phase, but the impact could be huge with AstraZeneca’s Matthew Bonam predicting that by 2020, “70-80% of data being collected by the patient in their own home, rather than centres, is probably achievable and good for everybody.”[xiv]
As 2018 continues, we’re likely to see an increasing push toward the acceptance of wearables, and an assessment on their efficacy for use in clinical trials. In the beginning at least, the focus of attention will be on what Michelle Peterson, the founder of Healthinnovations describes as “low-risk”, like fitness trackers or heart rate monitors.[xv]
4) Automated clinical trial supplies
The clinical trials consumables market is set to grow at 5% per-year between 2017-2021, and it’s going to change too. As trial managers seek to improve efficiencies in trial processes to save valuable resources, they are increasingly turning to the automation of clinical trial supplies.[xvi]
The complexity of modern clinical trials increases exponentially when conducted across multiple-sites and across various countries. An increasingly pro-active approach to managing clinical trial ancillaries has become a key driver for cost-saving in trials, and continues the trend toward automation.
What does this mean for the future?
The trend toward automation will increase, as will the push toward outsourcing. A 2017 industry study found that 53% of respondents outsource more than 61% of their trials budget – a figure that’s likely to increase.[xvii]
The industry is modernising with 69% of responders looking to invest in mobile technology during 2018, with data security issues the biggest barrier to adoption. Ultimately however, it’s personal relationships that still matter with close and reliable relationships the most important factor for clinical trial purchasers.
5) Cyber Security became a priority
The Petya attack that struck Merck could be the tip of the iceberg, claims the Pharmacy Times. [xviii]The industry sheet claims the risks of future cyber-attacks are ‘very real’. The WannaCry attack that crippled the NHS last year also demonstrates how simple vulnerabilities can be exploited by malicious hackers.
Financial losses from the attack could cost Merck’s up to $135m in revenue, but the reputational damage could be much higher.[xix] During 2017 the importance of cyber security - both for the organisation and the individual – was brought into stark focus. As we move forwards, lessons need to be learned.
What does this mean for the future?
By following simple safety measures, the WannaCry attack, and the vulnerabilities exposed at Merck, could have been stopped. As such, in 2018 we’re seeing more exploration into how new digital technologies like Blockchain can improve data security.
Using innovative encryption methods like Blockchain, data can be safely and securely shared across barriers and borders and solves some – but not all – of the interoperability challenges that can impact clinical trials.
Blockchain solutions allow secure access to clinical trial information. It can break down organisational silos and improve collaboration. It’s not the solution to every problem, but Blockchain technologies are likely to become ever more important for clinical trials.
[i] Clinicaltrials.gov. (2017). Trends, Charts, and Maps - ClinicalTrials.gov. [online] Available at: https://clinicaltrials.gov/ct2/resources/trends [Accessed 15 Dec. 2017].
[ii] Grignolo, A. (2017). Phase III Trial Failures: Costly, But Preventable. [online] Appliedclinicaltrialsonline.com. Available at: http://www.appliedclinicaltrialsonline.com/phase-iii-trial-failures-costly-preventable [Accessed 15 Dec. 2017].
[iii] Sharma, N. S. (2015). Patient centric approach for clinical trials: Current trend and new opportunities. Perspectives in Clinical Research, 6(3), 134–138. http://doi.org/10.4103/2229-3485.159936
[iv] Bioethics International, Good Pharma Scorecard. Online. Available from: https://bioethicsinternational.org/good-pharma-scorecard/ [Last accessed 18.12.2017]
[v] Clinical Leader, How Big Pharma Is Tackling Patient Centricity & Diversity Challenges In Clinical Trials. Online. Available from: https://www.clinicalleader.com/doc/how-big-pharma-is-tackling-patient-centricity-diversity-challenges-in-clinical-trials-0001 [Last accessed 18.12.2017]
[vi] Startups, Clinical trial matching platform Antidote raises $11m, Online. Available from: https://startups.co.uk/clinical-trial-matching-platform-antidote-raises-11m/ [Last accessed 18.12.2017].
[vii] Southey, F. Recruitment gets personal: Localised strategies can increase participation, say site execs, Outsourcing-Pharma.com. 13.12.2017. Available from: https://www.outsourcing-pharma.com/Article/2017/12/13/Recruitment-gets-personal-Localised-strategies-can-increase-participation-say-site-execs [Last accessed: 18.12.2017]
[viii] Clinical Leader, An FDA Perspective On Patient Diversity In Clinical Trials, Online. Available from: https://www.clinicalleader.com/doc/an-fda-perspective-on-patient-diversity-in-clinical-trials-0001 [Last accessed: 18.12.2017]
[ix] Official Journal of the European Union, Regulations, Online. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf [Last accessed: 18.12.2017]
[x] European Commission, European Open Science Cloud. Online. Available from: https://ec.europa.eu/research/openscience/index.cfm?pg=open-science-cloud [Last accessed:18.12.2017]
[xii] Clinical Leader, Wearable Derived Data In Clinical Trials: The Biggest Barriers Are Crumbling, Online. Available from: https://www.clinicalleader.com/doc/wearable-derived-data-in-clinical-trials-the-biggest-barriers-are-crumbling-0001 [Last accessed: 18.12.2017]
[xiii] European Commission, Smart Wearables: Reflections and Orientation Paper. Online. Available from: ec.europa.eu/newsroom/document.cfm?doc_id=40542. [Last accessed: 18.12.2017]
[xiv] Southey, F., Clinical Trends 2020: Virtual Trials, patient recruitment and mobile tech. Outsourcing-Pharma.com. Online. Available from: https://www.outsourcing-pharma.com/Article/2017/11/30/Clinical-trends-2020-Virtual-trials-patient-recruitment-and-mobile-tech [Last accessed: 18.12.2017]
[xv] Clinical data from wearables: Quality, regulatory and privacy concerns. Clinical Trials Innovations, Online. Available from: https://knect365.com/clinical-trials-innovation/article/a5d394f9-7488-48e3-8471-7b3b3563f095/clinical-data-wearables-quality-regulatory-privacy [Last accessed: 18.12.2017]
[xvi] Ashkay, J., Clinical Trials Consumables Market Analysis, Growth, Size, Share, Trends, Sales Forecast and Supply Demand, Miltech, Online. Available from: http://www.military-technologies.net/2017/12/13/clinical-trials-consumables-market-analysis-growth-size-share-trends-sales-forecast-and-supply-demand-2/ [Last accessed: 18.12.2017]
[xvii] Sookne, K., Survey Reveals Current and Future Trends in Clinical Trial Supplies Market, Logistics for the Life Sciences, Online. Available from: https://www.logisticsforthelifesciences.com/survey-reveals-current-and-future-trends-clinical-trial-supplies-market [Last accessed: 18.12.2017]
[xviii] PharmaTimes Online, The very real online threat to the pharma industry. Online. Available from: http://www.pharmatimes.com/web_exclusives/the_very_real_online_threat_to_the_pharma_industry_1212764 [Last accessed: 18.12.2017]
[xix] Healthcare IT News, Petya cyberattack cost Merck $135 million in revenue, Online. Available from: http://www.healthcareitnews.com/news/petya-cyberattack-cost-merck-135-million-revenue [Last accessed: 18.12.2017]