As 2019 comes to a close and a new decade emerges, many are reflecting on the year and setting new ambitious goals and resolutions. For us at Medrio, looking back at the past 12 months, we’re thrilled at the progress and momentum we saw in our efforts to support pharma, medical device, and diagnostics organizations doing incredible work to advance public health around the world. There’s no question in our mind that it was a phenomenal year across the clinical research industry.
As we kick off 2020, we’re optimistic that this year will see unprecedented advancements in public health, and we’re ready to support researchers with our best-in-class eClinical suite. In the spirit of transitioning from one decade to another, let’s look back on 2019 and ahead to what researchers need to prepare for in 2020:
2019 clinical research milestones
Due to regulatory shifts and technological advancements, our industry is undergoing rapid evolution. Last year, we worked hard to keep our company aligned with the changing needs of the industry and found these noteworthy trends as having implications for both Medrio and researchers worldwide:
Globalization: There is no doubt that clinical research is rapidly globalizing. Asia-Pacific (APAC) is now the fastest-growing region in the world, surpassing both North America and Europe, and China alone has seen a massive 451% growth in clinical trials since 2010. We can partially attribute APAC’s rise to regulatory reforms to expedite timelines, large patient pools to recruit from, and typically lower costs than traditional research locales. Researchers need to be aware it’s only going to be more common to collaborate across oceans and timezones and familiarize themselves with global data regulations to ensure compliance.
Medical device regulation (MDR): Last year, MDR was top-of-mind as organizations prepared for this massive regulatory shift. The critical takeaway from MDR last year is that all researchers, regardless of their industry or target market, need to embrace reliable technology, not only to stay competitive but also to remain compliant with global regulations. Regulators have made it clear they want organizations to adopt innovative tech and protocols and provide additional post-market and real-world data.
Patient centricity: Patient recruitment, retention, and adherence rank among the top 3 research challenges and account for massive portions of research budgets. As the industry battled to reduce cost and complexity in 2019, patient-centricity emerged as a key pathway to solving recurrent research problems. Decentralized and hybrid trials gained momentum and are now poised to revolutionize clinical trials by significantly reducing patient burden, costs, and timelines. In December 2019, we were excited to sponsor the first-ever virtual trials conference, which brought together leading organizations as well as FDA officers to discuss how to implement these new models while staying compliant.
Oncology success: Finally, immuno-oncology (IO) and personalized cancer treatments saw significant advancements and are exploding with even more potential. The FDA recently approved IO therapies for almost 20 types of cancer, including advanced tumors, blood cancers, and cancers with specific genetic defects. Ongoing clinical trials are also testing the benefits of IO agents on other types of cancer, leading to hope that a cancer prognosis will be much more positive soon.
Clinical research 2020: from discussion to action
2020 is going to be all about making greater strides and taking action on the key topics discussed in 2019. Here’s what researchers need to prepare for:
More global trials: As researchers continue to look for ways to improve patient diversity and accelerate their work, we expect the globalization of research to continue in 2020. Many vendors are ready to conduct more trials in APAC, and we’ve recently set up new servers in China to ensure we are compliant with Chinese data regulations. As global trials become the norm, organizations need to develop strategies and invest in technology to overcome challenges that come with collaborating across large distances. For us, that means eSource, including direct data capture (DDC), eConsent, and ePRO, which play a crucial role in helping research teams work together across the world in real-time, capture higher quality data, and simplify monitoring.
More virtual and hybrid trials: While 2019 saw plenty of talk about decentralized trials, this year, we expect to see action. We anticipate more virtual and hybrid trial pilots and predict that there will be a focus on regulatory compliance in patient-centric technology. We’re prepared to support researchers in conducting patient-centric, decentralized trials with our unified eSource-EDC system.
MDR will go into effect in May 2020: For device companies and otherwise, preparing early for compliance positions yourself for long-term prosperity and success. MDR brings several highly impactful changes for medical device developers, manufacturers, suppliers, CROs, and notified bodies. It’s important to know that MDR has binding legal force throughout the EU, and failure to meet requirements could have expensive legal repercussions. We’re happy to say that our software and team are prepared to keep our customers compliant with the sweeping regulatory shifts ahead.
Rare disease, oncology, and central nervous system (CNS) progress: With new trial models, scientific methods, and discoveries, we’re looking forward to developments and breakthroughs in rare disease, oncology, and CNS. In the past, it was especially challenging to enroll and retain patients in these areas since they were often widely dispersed or in poor health. Now, decentralized trials and increased funding are overcoming these long-standing challenges, giving us hope that we will see rapid progress this year. Additionally, blood-brain barrier (BBB) innovation is rapidly increasing, providing hope for better treatments for Alzheimer’s, Parkinson’s, and Hunter’s syndrome.
So, what’s our primary goal for 2020? Like in year’s past, it’s to support pharma, medical device, and diagnostics clinical researchers with proven and reliable eClinical tools that enable faster access to more accurate data, prompting earlier insights and interventions. With our growing international team up and running and stronger than ever, we’re looking to strengthen our existing relationships and establish new ones with innovators chasing the next breakthrough in public health.
Here’s to you! Let’s make this decade the best yet for clinical research. Happy New Year!