I’m often asked, by clients across the globe, what the main Clinical Operations challenges facing pharma and biotech companies really are. Where are they investing their resources? What takes up their time? Where are their efforts going to be focused in the future?

The answer is rarely as varied as expected. Often, no matter what size the company or the internal expertise they have, the same difficulties keep appearing.

So at our recent Clinical Operations Strategy Meeting, held in Boston, we asked them. Over 130 senior decision makers from Takeda, Pfizer, Novartis and more shared their thoughts: here’s what we found. There’s also a full link to the report we put together at the bottom of this article.

Or, if you’d prefer to discover these insights firsthand, join us in San Diego on May 11.

Main Challenges Facing Pharma/Biotech: 2020 and Beyond

PATIENT RECRUITMENT AND RETENTION

Patient recruitment was ranked as the most important challenge facing clinical operations professionals in the next few years. Delegates mentioned that retention of patients, general patient access to clinical trials and patient engagement were serious considerations for the next decade.

OUTSOURCING/PARTNERSHIP

Clinical outsourcing, including construction of models for outsourcing, were specified as another major challenge within the industry. Partnering with other pharmaceutical companies was also rated as a major challenge, as was identifying who to partner with.

DATA 

Many of the delegates surveyed mentioned data in its many forms as being a unique challenge in the years ahead. Surveyed experts cited problems around data mining, quality, collection and analysis as areas they were looking to improve.

COST AND RESOURCE

Costs and problems with resource were a major problem many experts had. Delegates discussed attempting to reduce costs in clinical studies, personnel management and allocating internal resources most efficiently.

SITES

Issues relating to sites were shared by many experts. Particular problems included site activation, building capacity in sites, identifying key sites for clinical trials and engaging with sites.

RISK MANAGEMENT

Risk management was another issue faced by several surveyed delegates. Among other issues, those surveyed cited the need to mitigate risks at program and study level, ensure data quality through risk-based monitoring, and database lock via use of central and risk monitoring as future challenges.

INSPECTIONS

Insuring inspection-readiness at all times was another challenge that a number of delegates specified. The issue is not set to abate any time soon, especially given the difficulty of finding a solution with any innovative technology currently on the market.

What Will the Future of Clinical Operations Look Like: An Expert Opinion

PATIENT- AND SITE-CENTRISM

A focus on patients was mentioned by several facilitators as particular important, especially since this is also an FDA focus. One expert brought up hat there are other ways to talk about the topic, including on the site side. Questions about how sites can better focus on patients were deemed necessary for improving patient-centrism in the future.

One expert, an executive director in clinical development, thought that technology was playing a large part in facilitating this increasing patient focus, both at a company and site level: the ability to allow patients to access and more easily understand important information, even if they’re 200 or more miles away, can make it easier to find individuals to participate in trials and manage their safety more easily.

DATA INTEGRATION

Another emerging trend in clinical operations, as with many areas in pharmaceuticals, is the integration of numerous data types. One facilitator noted that there would be a big trend soon towards moving electronic health data into data capture systems, potentially eliminating a huge burden at site-level and transforming many companies’ workload.

Another said, conversely, that while connecting different systems used in managing clinical trials, or connecting all a company’s systems no matter the trial, is enormously useful, it has been talked about for a long time without coming to fruition. She noted that there had certainly been progress in terms of interfacing, but the biggest revolution would only come when companies can link all systems and put metadata in place, and all datasets can be accessed from one location.

RWE AS A SUBSTITUTE FOR ADDITIONAL CLINICAL DATA

One VP of clinical affairs suggested that the field was moving more towards ePRO and real-world evidence (RWE), particularly as a substitute for procuring additional clinical data. This is particularly the case in the U.S, he said, where the barrier to market is moving lower. In that country, once a product is in the market it’s there for good, as opposed to the E.U. The FDA is slowly adopting this latter model, so the next few years will see a greater take-up of collecting RWE, in turn needing more electronic data capture from patients.

QUALITY AND RISK-BASED MONITORING

One expert, a senior manager of clinical affairs, suggested that ensuring compliance with quality requirements is a significant issue at the present, with strong regulator focus around how quality is tracked and managed. She noted there is considerable guidance around the issue, with particular focus on demonstrating sponsor oversight.

She said there needs to be a greater focus on inconsistencies across health authorities and between companies. While creating new systems can be profitable, without following specific principles they are difficult to manage.

She added that monitoring will greatly change how CRAs interact with sites, especially since the focus is more on managing the training and knowledge-base of the site. Due to risk-based monitoring (RBM), there’s less focus on actual hands-on work regarding source data verification. So the future focus will be more on how well-trained a site is to be able to take on a study, and how well the study can be conducted.

So there you have it. Straight from the horse’s mouth, the challenges and future predictions for the field of clinical operations.

We gathered lots more great insights from the Clinical Operations Strategy Meeting and our editor has conveniently collected them all in our latest Trends Report, which you can download here.

I look forward to discussing these issues with you throughout the year.

Louis Smikle, CEO
Proventa International