As the year 2020 comes to a close—and what a year it was—professionals from all corners of the industry are looking back on the technological advances, market demands, world events and other influences on key developments. Here, a number of leaders share their perspective on the dynamic events of 2020 and offer predictions on how the landscape might shift in the next 12 months.
Rasmus Hogreffe, vice president of decentralized trial innovation, Medable
The COVID-19 pandemic turbo-charged the use of virtual tools and a decentralized model for clinical research but as life resumes more normalcy, pharma will continue its pace of adoption of decentralized clinical trials (DCTs). Investigator sites, who have been stuck between the ‘fear of missing out’ and the fear of the unknown, will cautiously push forward with DCTs as they see patients receiving better care.
It will not happen overnight, but sites will slowly have less trepidation as they see the impact that a decentralized approach has on patient care. DCTs allow patients to stay safely in their homes and still have physician-monitored access to potentially life-altering new therapies. And, because patients’ health is surveilled continuously using wearables, electronic diaries, virtual check-ins, and other tools, they receive premier care. Sites can respond in real time and engage directly with patients more often.
DCT adoption will steadily increase through 2021 as improvements in patient care, data quality, and trial outcomes assure sites, sponsors, regulators, and patients that there is nothing to fear.
Patrick Hughes, chief commercial officer and cofounder, CluePoints
The pandemic will undoubtedly ensure that the long-promised paradigm shift in how clinical trials are conducted will finally become reality. Sponsors have to do more with less if they have any chance of seeing an increase in drug development pipeline activity. Virtual trials, remote monitoring, wearables, risk-based quality Management will all become the standard within trials of the future and as soon as 2021. This is the catalyst that the industry needed to take a long hard look at itself and now that we’ve proved it’s possible, there’s no going back.
Minesh Pore, CEO and cofounder, BuyHive
2021 will bring reconciliation and stabilization in some areas of the supply chain while regulations and restrictions will continue to evolve, travel restrictions will linger. Transparency and trust will need to be present in global supply chain management.
The future of the industry will begin with partners and their API's that will help improve the sourcing ecosystem, it's not about developing your own, but rather collaborating with experts including Trade Insurance, Freight, 3PL, Trade Insurance, Recommendation engines, factory verification, etc.
Bernard Vrijens, CEO and scientific lead, AARDEX Group
There are numerous ongoing trends that must keep progressing for the benefit of the industry – most importantly these include patient centricity, artificial intelligence, machine learning, big data and personalized medicine. As sponsors adapt, they are turning to digital solutions that comply with the new world order, while also boosting patient centricity and overcoming deeply entrenched challenges.
Medication nonadherence issues in clinical trials has always existed but had been somewhat overlooked until recently. It is one of the main reasons for clinical trial failure, but it does not have to be. The technology exists today to mitigate this risk. The combined solution of AARDEX’s Adherence Management solution and smart packaging and smart device technologies that seamlessly connects the GCP and GMP worlds is available now.
Evidence-based digital monitoring solutions, which are more effective at improving adherence than traditional methods such as pill counting or blood sampling, can play a vital role in the implementation of robust, patient-centric DCTs. Ultimately, as the industry adapts to meet the challenges of research in the COVID era, it is the adopting and endorsing of modern digital solutions that will not only keep the research wheels turning but will make clinical trials more patient friendly.
The pharma industry needs to shift to a more efficient drug development process. In this regard, MEMS Adherence Software is the most efficient solution to measure and manage medication adherence in traditional trials as well as in decentralized or hybrid clinical trials.
Jeremy Edwards, CEO, Raremark
We expect to see advances in how tech is used in healthcare as the biggest trend – from apps to communicate with HCPs virtually, all the way to wearables used to collect trial data. This year has seen a lot of conversation happening about decentralized trials, and next year we expect to see more trials designed with these approaches and solutions that help with implementation.
We also expect pharma to involve patients earlier on in the drug development process as patient centricity becomes even more embedded into the industry mindset. Educating patients and giving them a stronger voice in clinical research will also be a key area of focus for the industry – our data shows there’s still lots to be done in rare disease to educate people about clinical trials and create research programs adapted to patient needs.
Lisa Jane Lishman, commercial director and partner, Page & Page and Partners
For once, it’s not hyperbole to say 2020 has been a year unlike any other and the healthcare industry has had to act rapidly to deal with coronavirus. Resourcing has been one area that exemplifies this.
In the pharmaceutical industry, company time and money has been diverted to developing a COVID vaccine. As we make our way into 2021, we’ll begin to see the bigger picture and understand what COVID has truly cost the healthcare industry.
Liz Beatty, chief scientific officer, Inato
Here are my top three predictions for clinical trials in 2021:
- There will be continued focus on diversity in clinical trials. The lack of diversity in clinical trials is finally being recognized as a societal issue. It’s also an issue that creates significant community and global health risks, as diverse patient populations have different responses to certain diseases and pharmaceuticals. Currently, diverse patient populations don't have easy access to the large academic sites and that needs to change. In 2021, there will be a larger systematic effort to diversify participants in clinical trials. More sites and sponsors will begin using data-driven metrics to track and progress against their diversity goals.
- Sponsors will continue to look beyond large AMCs to conduct trials. The industry has tried to reverse the rising cost trends by partnering even more with the largest sites. However, reducing the number of sites per trial drives increased site competition, while increasing the number of patients required per site drives patient competition at the site level and limits widespread patient access. In 2021, We anticipate sponsors will continue to look at new engagement models with sites, and different technologies such as a marketplace to more quickly identify naive patients for trials.
- Community comeback: Patients are less able & willing to travel to participate in a trial (COVID + changes in patients’ habits and expectations). Addressing patient participation requires a reimagining of the way sites and sponsors collaborate on clinical trials. Trials need to adapt to patients -- not the other way around. This means enrolling and treating patients where they are, in their communities.
Thanks to COVID, 2021 will be the year where we finally bring clinical trials to the community, but it will take a shift in how sponsors partner with sites.
Serge Bodart, chief commercial officer, IDDI
Randomized clinical trials (RTCs) remain the gold standard in assessing a drug’s benefit; however, the pandemic has highlighted certain vulnerabilities. Cost per participant can prohibit recruitment and limited specialized resources are needed for endpoints, affecting statistical power. In addition, clinical trials are not always reflective of clinical practice due to restrictive protocols and narrow selection criteria.
The global pandemic has revealed that the current way of conducting RCTs is inflexible and inefficient. However, the industry must move forward and continue to progress. This has been possible through a willingness to embrace new ways of designing, conducting, analysing and reporting clinical trials.
This necessity to adapt under pressure and in a short timeframe will have a long-lasting effect on our industry. It is essential and advisable not to revert to our old ways of working.
The pandemic had led to unprecedented speed in methodological and clinical development, which has presented opportunities for national and international collaboration, and has simplified and sped up procedures. We can only hope this trend continues.
The pandemic has also placed biostatistics, epidemiology, virology, infectiology, vaccinology, and related fields in the spotlight in an unprecedented way, implying great opportunities, but also the need to communicate effectively, often amidst controversy.
Andrew Rut, CEO and founder, MyMeds&Me
To date the industry has been relatively conservative in its approach to digital transformation, but the pandemic led to changes in almost every aspect of our lives and has broken down barriers through enforced change. The public, healthcare systems and governments will no longer accept drug development, and the immediate post-approval phases, that take years if not decades.
As we see the design of new medicines become more rapid there must be a parallel drive to orchestrate proactive and post-approval surveillance whether within programs or through easily accessible safety data capture. The industry’s goal has to be to get drugs and vaccines to the market faster but also to be prepared to address as yet unknown safety issues much faster.
We know that clinical trials must be selective in their participation, duration, and endpoints. The real world is far more complex and therefore the time delays for previous medicines or vaccines - where delays in data collection, collation, or analysis exposed people to risk – must be addressed.
We’ll see a greater drive to replace outdated systems with digital technology that can ensure reliable, relevant, and robust data in real-time for analysis and insights. In addition, as the global concerns around data security and data privacy increase, pharma will learn again that building technology vs buying technology is not a sustainable model.
Julian Minett, CEO, Spencer Group
Working in partnership with our long-standing network, our year has followed a similar path to many eClinical organisations that have seen success this year. 2020 began with a strong trading Q1 as eClinical businesses continued to grow, however, as the world and the pharmaceutical industry looked to define its reaction and then execute its response to COVID-19, our Q2 was quiet with theirs.
As many clients began to scale rapidly to support the significant increase in eClinical demand and looked for our support across Q3/4, we are delighted to have achieved a record-breaking year overall. As a reflection of the pace in which we have moved to support the uptick in demand across the market, we have doubled the size of our team and continue to grow in order to facilitate our clients as they look to hire not only individual executives but entire sales teams across the US, Europe and Asia.
We have seen a significant increase in demand for established technologies such as CTMS and eCOA, a wider interest in RBM and eConsent and a game changing focus on the evaluation of hybrid/decentralised, and even virtual trial solutions. We have been impressed by the industry’s determination and agility in its reaction to COVID-19 as organisations have set up trials in 1/10th of the normal time to support critical vaccine trials, enabling sponsors to deliver vaccines at an unprecedented rate.