This past year has been extraordinary for each one of us, and our industry has taken center stage. As the world looks to clinical research to bring the threat of COVID-19 under control, the regulatory affairs space has become a focus of scrutiny, both from within the industry and from the world at large. Recently, Worldwide Clinical Trials conducted a poll of industry leaders, asking them to prioritize their key areas of focus for 2021. It is unsurprising that patient recruitment is an ongoing concern, while other emerging areas of focus are technology, data harmonization, and transparency.
As we move into 2021, I’d like to offer my predictions for the regulatory space.
Prediction #1: Regulatory Professional, an Agent of Transparency
In 2020, we’ve seen an increased collaboration among regulatory agencies, a shift we hope will foster increased sharing of data and expertise beyond the COVID-19 disruption. Our internal scrutiny is well established, and now public pressure demands more transparency from the drug development industry. We are challenged to build bridges between insider knowledge and public accountability, to make information available and accessible to laypeople. This means that clinical trial experts should become more engaged with the public, proactively communicating rationales behind decisions and strategies. For this approach to work effectively, regulators should be viewed as more than the final gatekeepers to approval.
I am optimistic that increased transparency will result in increased collaboration among all stakeholders, patients included, in every stage of study. Regulatory professionals can expect to have a seat at the table earlier in the clinical development process. The added involvement of regulatory affairs will lead to a growth in demand for regulatory professionals in 2021. In our poll of industry leaders, 75% of respondents indicated that advanced technology adoption will be their biggest area of focus for 2021. The industry needs individuals who can interpret and communicate regulatory considerations in the context of the burgeoning areas of technology, recruitment/retention, and data harmonization.
Prediction #2: Educating the Public, Accurately
COVID-19 is shifting the public’s interest in clinical trials from a desire to know the end results to curiosity about the transparency of the entire study process. With so much riding on the search for COVID-19 treatments and vaccines, people want to know how their drugs get developed so quickly – and then how do they get approved. The downside of this increased curiosity is that it has precipitated a rash of conflicting headlines that risk undermining public trust in clinical trials. I predict the effects of this period of uncertainty will impact the industry well beyond the pandemic.
In this moment, regulators have an opportunity to harness the heightened public interest in a way that can build trust and engagement. For this engagement to be effective, we must educate the public on the importance of clinical research and development, providing accurate and authoritative information. As the public’s demand increases for transparency from their government, the responsibility falls on regulatory agencies to keep laypeople accurately informed with respect to clinical research, now more than ever. When recruiting for clinical trials, we must anticipate more questions and be prepared to give clear and definitive answers so that we reiterate our commitment to transparency and thereby reinforce public confidence. Recruitment efforts must be enhanced to treat the patient as a full partner in the development journey, educating and informing accordingly. I predict that the industry will increase its efforts to bring the public along the way in future R&D projects.
Prediction #3: Solving the Recruitment/Retention Puzzle through Diversity and Inclusion
The COVID-19 crisis has highlighted the fact that increased patient diversity is crucial to achieving globally representative data. Increasing inclusiveness in trial participation puts us on track to achieve a host of operational benefits and create more medical value for patients. While the rate of recruitment in clinical trials globally has increased in recent years, the rate of retention has decreased significantly.1 Some numbers suggest up to 25% of clinical trial participants drop out before study completion. Of course, low retention translates to needlessly high study costs and timeline lags, but it can also have more enduring effects. When study participants drop out, their dissatisfaction can diminish public confidence and undermine future recruitment potential.
In 2021, it won’t be enough to rely on medical doctors to recommend clinical trial participation. Regulatory agencies will need to recognize the diverse needs of patient populations and identify strategies for overcoming barriers to study participation, while incentivizing studies to make such accommodations. At the study level, recruitment activities should take into account the potential hurdles to study compliance and intervene proactively. Potential barriers to trial completion may include considerations related to geography, culture, religion, and local logistics. Surely, when our regulatory agencies provide stronger mandates related to diversity and inclusion, our studies will be better positioned to realize the benefits inherent in more inclusive recruitment practices. Increased diversity and inclusion in our studies is not only humane but also poses potential for larger recruitment pools and will render more accurate and realistic trial outcomes. In 2021, sponsors will need to navigate how to effectively incorporate the patient perspective, present this to regulatory agencies, and align with the push for diversity and inclusion.
Prediction #4: Real-World Evidence Makes Sense for the Real World
Just last year, the FDA granted the first drug approval based solely on real-world evidence (RWE).2 This approval is surely just the first in an evolution away from approvals based exclusively on clinical trial outcomes. 2021 is bound to be a growth year for studies using RWE. This development is particularly timely as we consider the urgency with which we are addressing the pandemic. Real-world evidence will enable expedited release of novel drugs to market. It can also enable the exploration of novel end points that have practical and realistic applications with respect to patient-centered outcomes.
Bear in mind, regulatory acceptance of RWE won’t be free of challenges. New procedures will be required to address questions of availability, quality, and diversity of RWE data. Trials will be required to engage data partners capable of recruiting diverse cohorts and creating data models that match the stringent criteria required of traditional clinical trial outcomes data.
Prediction #5: Striking the Balance with Digitized Patient Data
For years, technological innovation has been proposing improved methodologies for data management and patient monitoring. In 2020, the pandemic catapulted us into a scenario where industry must embrace these technologies. Now, we must catch up with the amount of patient data we are storing, and how we store it. This is an area that should not – indeed, must not – be self-regulated. In 2021, I predict that the industry will start to work to develop protocols focusing on the regulation of patient data. These protocols will require input from the industry as a whole, as regulators seek to moderate stakeholder interests and concerns around standardization, privacy, and ethics. Solutions like chain-of-custody data maps may become de rigueur for maintaining data integrity and managing data flow.
The ultimate goal is to benefit from the positive aspects of new technology, while safeguarding against associated risks. With data collection and management becoming increasingly cloud-based, industry should focus on articulating suitable approaches to standardization, ethics and privacy concerns, and regulatory considerations.
Prepare Your 2021 Regulatory Strategy
Do you have a regulatory concern or question? Reach out to Aman Khera today.