Henry McNamara

After two years of rapid change and transformation and technological adoption accelerated by the pandemic, pharmaceutical companies are now faced with more choices than ever before.

The industry has now become focused on cost-effective models that bring value. Today, there is not enough value in stitching together solo, siloed technology solutions. Instead, companies seek technology platforms that offer streamlined vendor engagement/management, configurability for scale and speed, and holistic analysis and insights. And these solutions must enable speed to market while keeping costs down.

Here are five key areas of innovation to watch as the life sciences industry looks to reach this pinnacle in 2023.

The global economic situation will lead to a consolidation of tech vendors. 

Over the last decade, there has been a boom in the number of startups in the life sciences space. But that won’t be sustainable as funding starts to dry up given the overall state of the global economy. There will be less capital and what capital is available will be risk-adverse However, this trend will not affect the number of trials at scale.

Expanded adoption of AI and Machine Learning will continue to transform the pharmacovigilance market. 

It’s critical that drug companies stay on top of new innovations/inventions as they come to market. As new treatments—such as the COVID-19 vaccines—come to market faster, patients and providers need to have accurate safety information and be informed of possible adverse reactions. A well-designed, automated system using the right technology can help eliminate tedious and repetitive tasks, reduce data entry errors, and even enable “predictive” signal detection.

The retail pharmacy model in clinical trials will continue to grow. 

 have instituted flexible clinical trial models that combine patient insights, technology capabilities, and in-person and virtual-care options to engage broader and more diverse communities. This type of collaboration will continue to grow and expand, resulting in more expansive participant pools and more accurate information about populations where drugs are effective and other populations where they might not be as effective.

Real-world data will be critical in decision making. 

Emerging platforms—like EHR and connected devices—will enable companies to collect larger quantities of high-quality real-world evidence. The insights from this data, combined with clinical research data, will shape drug companies’ approach to all aspects of business including discovery, understanding safety in real-world conditions, go-to-market strategies, and how they run their clinical trials.

Companies will pool data to try to get through regulators faster. 

As trial sponsors look for ways to gain regulatory approval faster, we will see companies that conduct trials in similar spaces pool their data to showcase a deeper set of results. Bringing together this type of large, cross-study data set will help demonstrate a wide variety of results to regulators, thereby potentially enabling a faster approval process. This pooling effort must be scientifically justified, prespecified, inferentially rigorous, and convincing to the medical community and regulators. An innovative biostatistical approach is needed for analysis of the pooled data.

The COVID-19 pandemic challenged status quo and served as a catalyst for the adoption of the technology-enabled ‘patient-centric’ decentralized clinical trials model. The reality of this shift to the new norm has led to most of the industry planning on continuing to implement newer clinical trial models and technologies. And with patient optionality ruling the day, organizations must plan on giving patients the choice about how they participate in clinical trials. The organizations that strike the balance of cutting-edge technology and patient centric models are the ones that will succeed in leading the industry this year.

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Following COVID-19, companies are focused on solutions offering the latest technology and most value to patients.

Five Areas That Will Define the Future of Clinical Trials

At the onset of the pandemic, the industry had to adapt quickly to keep trials afloat. This forced change helped researchers understand when and how to implement alternative approaches to improve clinical research. Methods and technology that were being explored pre-pandemic–from remote monitoring to video visits to phone visits, eConsent and EHR–have come front and center during the past 18 months and will remain for the foreseeable future.

Now, as we head into 2022 the big question remains: Is our industry ready to sustain this pace of change?

According to recent research from Oracle and Informa

, the answer is yes. Our study found that 97% of organizations who implemented changes to their clinical trials approach during the pandemic indicated their organization would continue using at least one of these new methods. Remote monitoring, video visits, EHR, and phone visits were the approaches most likely to continue.

Here are three more predictions for the life sciences industry as we enter 2022.

Confidence in the data generated from newly adopted clinical trial approaches will continue to grow

With the introduction of new approaches and technology in clinical trials–especially those related to remote data collection from patients–comes an increase in data volume and variety. More importantly, the data is only as a good as the confidence that people have in it.

Oracle and Informa’s recent study found that 92% of respondents who implemented new clinical trial methods during the pandemic are equally or more confident in the data collected from these methods, compared to data collected via pre-pandemic methods. This confidence will continue to build as comfort with, and expansion of, newly adopted technologies and approaches expand.

 on decentralized trials, nearly half of respondents said that data reliability and quality (50%) and data collection (45%) were key concerns in adopting decentralized clinical trials. This significant increase in confidence in the past year supports the industry’s continued progress towards more decentralized models.

Community sites will provide opportunities for expanded patient recruitment

In order to attract new trial participants, it is critical for pharmaceutical companies to make it easier for patients to access trial locations that are convenient for them. Our study found 61% of respondents believe allowing patients’ choices will have a positive impact on clinical research and well over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward.

To this end, retailers like CVS and Walgreens for example, could become more popular as trial locations. By collaborating with these locations, sponsors will have expanded opportunities for patient recruitment because they will be offering patients the convenience and comfort of visiting community sites in which they are familiar.

With the industry still adjusting to new approaches in aspects of study start-up, recruitment, and data collection, regulators will respond by allowing a wide berth to help accommodate the adoption of these methods. This regulator flexibility will be key, but further implementation of decentralized methods will be driven by the industry at large.

The pandemic has and continues to put enormous pressure on the entire life sciences industry and those organizations running clinical trials. At the same time, it has provided the impetus for moving at least some aspects of clinical trials out of pilot mode and into action. In 2022 we will continue to move into the new era of clinical trials supported by technological innovation.

Data, patient recruitment, and regulators all highlighted in these three predictions for the new year.

Henry McNamara

Articles

Five Areas That Will Define the Future of Clinical Trials

Life Sciences in 2022: A Transformation Continues