We are at a crossroads with respect to Drug development and Clinical Trials

Clinical trials are at the heart of the evolution of modern medicine, ensuring safety and efficacy while generating vast amounts of patient insights that is immensely resourceful for real-time and predictive analyses to better manage health outcomes. However, they come at a significant cost. ~85% of all clinical trials experience delays, with 94% being delayed by over a month1. Additionally, clinical trials are getting increasingly complex and challenging to plan, run and sustain:

  • Recruitment remains a challenge - 69% of patients fail pre-screening, 58% decline consent1
  • Conservative trial designers need to factor in 30% patient dropout rates2
  • Protocol complexity is on the rise - The total number of endpoints rose 86% in the last 10 years3

Additionally, since the onset of COVID-19 pandemic, patient access has become an urgent priority. At its peak, 30,000 trial sites were suspended trials in June 2020 due to the pandemic4. The recovery has been slow – organizations continue to report trial disruptions as of Feb 2021 due to delayed initiation, delayed enrollment, and inefficient enrollment.5

Clinical trials of tomorrow need to factor these bottlenecks in the pursuit of patient centric and robust trial conduct.

There has been a strong push towards digitalization in Life sciences in recent times

USFDA recently issued guidance on a decentralized approach to clinical trials in the wake of COVID-19. Recognizing that a fundamental change is around the corner, the industry has formed an alliance – the  Decentralized Trials Research Alliance (DTRA) – to enable collaboration and create robust ecosystem to accelerate adoption of patient-focused, decentralized clinical trials as well as encourage research and education within the life sciences and healthcare industry.

Regulatory guidance has been opening up the use of digital in clinical trials

FDA

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2016

21st Century Cures Act – FDA gives digital push

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2018

Use of Mobile Technologies in Clinical Research – CTTI Guidance

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2018

CTTI Recommendations: Decentralized Clinical Trials

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2019

FDA affirms interest in Decentralized Clinical Trials

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2020

FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency suggests a decentralized approach

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EMA

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2019

Guideline under development on “Electronic Systems and Electronic Data in Clinical Trials”

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Health Canada

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2020

Called out the use of decentralized trials in May 2020 guidance “Applications for drug clinical trials under the Interim Order”

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So, what are Decentralized Clinical Trials and why are they critical?

The Clinical Trial Transformation Initiative (CTTI) defines Decentralized Clinical Trials (DCT)6 as clinical studies executed through telemedicine and mobile/local healthcare providers, enabling participants to continue with their day-to-day lives with minimal disruption and improve data acquisition, in order to:

  • Increase patient retention
  • Efficiently manage resources
  • Improve data quality and reduced cost
  • Ensure broader patient access across geographies
  • Increase patients access specifically with rare diseases

While decentralized trials take into consideration the priorities of all stakeholders involved to ensure a positive outcome, the industry continues to strengthen efforts to incorporate the participants viewpoint into all research and trials.

The novel capabilities offered by DCT empowers the patient across the entire lifecycle of the trial to be involved in all decision-making process and allow better access to experimental treatments.

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 The novel capabilities offered by DCT empowers the patient across the entire lifecycle of the trial

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Where the rubber meets the road - What does it take to decentralize the trials?

The pursuit of decentralization doesn’t need to be an all or nothing approach. Clinical trials should be designed with focus on value to patients, feasibility and data reliability and a hybrid approach may often be more desirable than a fully decentralized one. Identifying the right opportunities and challenges from the outset and developing sound mitigation strategies will set us up for success.

It requires a focused approach to decentralize the trials, starting with an initial assessment of current state till finalizing the most robust strategy for study design and data management. Multiple factors such as having strong operating model and foundation for a future-ready technology along with weaving in agile methodology is extremely essential to improve the chances of success.

Planning and executing DCT require novel and specific capabilities. Bringing components of studies directly to patients’ homes and their communities involves a lot of variables such as patient safety, suitable technology, accurate data collection, etc. Having the right capability mix, creating a favorable ecosystem, and overcoming feasibility challenges would lead us to truly Decentralized Trials over time.

While we still do not envision organizations to implement fully decentralized clinical trials across their entire portfolio in a consistent way, we at Accenture are taking active and progressive steps to develop experience and expertise across different parts of the trial lifecycle and potentially build a conducive ecosystem to support DCT.

With industry consulting and technology at the heart of our operations; alongside our focus on digital and innovation, our aim is to enable full-fledged decentralization of clinical trials:

  • Pre-trial engagement – Plan studies by leveraging predictive analytics, support and improve patient recruitment and seamlessly manage multiple vendors.
  • Trial Planning and setup – Virtual Principal Investigators (PIs), remote medical oversight, device provisioning and tracking.
  • Site Management – Enabling Sponsors and CROs to educate patients virtually; support tools such as Device and Platform user guides, risk based monitoring and real-time trouble shooting, etc.
  • Trial Execution – Ability to collect data from modern data sources without loss of data fidelity through ePRO, wearables, eScreening, eConsent, Device and software integration etc.
  • Trial Close-out – Efficient instream data review and close out after Last patient Last visit, intelligent data transformation for reporting and regulatory approvals.

Overall, the outlook of drug development and access to clinical trials for patients looks positive, with radical transformation expected in the coming years. A strong leadership resolve and the right capability mix is the way to establish the right foundation and ecosystem. To amplify value for patients and sponsors, impermeable data interoperability and best standards of data security is of great importance, in order to create top notch note-worthy patient experiences and revolutionize the entire conduct of clinical trials.

To discuss possibilities of decentralized trials, please reach out to christina.gunther@accenture.comvinod.mrithinjayam@accenture.com and neha.sobti@accenture.com

Our latest thoughts for Innovation in Drug development is available HERE

Sources:
1https://www.mesm.com/blog/tips-to-help-you-avoid-costly-clinical-research-delays/
2http://ipimediaworld.com/wp-content/uploads/2013/04/Patient-Recruitment-The-Most-Recognized-Silent-Driver-of-Clinical-Development-Costs.pdf
3http://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5b4de76e352f53bd7a416e1b/1531832174796/julaug-summary.pdf
4https://www.europeanpharmaceuticalreview.com/article/133362/clinical-trial-disruptions-is-it-all-down-to-covid-19/
5https://www.globaldata.com/covid-19-disruption-clinical-trials-varies-therapy-area/
6https://www.ctti-clinicaltrials.org/

Neha Sobti

Managing Director – Consulting, Life Sciences, R&D Operations


Vinod Mrithinjayam

Managing Director – Strategy & Consulting, Life Sciences


Christina Gunther

Senior Manager – Life Sciences, European Clinical Lead

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