Trends in Clinical Development

Industry benefits from heightened innovation, site/sponsor relationships, and diversity.

Over the last two years, the drug development industry has experienced an acceleration of change. Despite the many COVID-19 related challenges upending global operations, the industry continued to increase its level of productivity and innovation, evolve its relationships with sponsors and sites, and deepen its focus on diversity.

Heightened productivity and innovation

Across COVID-19 and non-COVID-19 drug development landscapes, the market has been extraordinarily productive. On the COVID-19 front, unsurprisingly vaccines and treatments increased seven-fold between May 2020 and May 2021.1 In addition to the high quantity of compounds in development, we saw unprecedented global cooperation, funding for vaccines and therapies, and resourcefulness of the industry. As a result, development timelines were compressed significantly—allowing COVID-19 vaccines and treatments to reach the market, on average, in two years compared to seven years.1

Contrary to expectations, as the industry dedicated resources to COVID-19, indicators show that productivity in other therapeutic areas outpaced expectations and continued reaching new heights. Key indicators include,

  • 6,400+ drugs were in clinical testing in 2020, the highest number to date.2
  • New clinical trial starts reached a new record of 38,364 registered trials in 2021.3
  • 2020 and 2021 were the two of the top three highest years for novel drug and biologics approvals.2

Even after normalizing these trends for COVID-19, the level of productivity is still at a record pace. One factor aiding in this productivity was the accelerated adoption of decentralized technologies during the pandemic. Several tools, like telehealth, home visits and direct-to-patient shipping, started to be used during the pandemic and today, technologies like these and others are used in 80-90% of clinical trials.4

Evolving sponsor and site relationships

Sponsor and investigative site relationships have also evolved in recent years. For example, with sponsors, non-Top 50 pharma companies hold 63% of the share of pipeline activities and 58% of approvals are in the rare and orphan disease space.5 This changing sponsor type and their development focus present increase demands on clinical research organizations while also creating deeper challenges with trial complexity and recruitment.

Although heavily impacted by the pandemic, sites have also become more productive as well as diverse and consolidated. For example, in 2020, 32,077 investigators filed at least one 1572, the highest number to date, and 44% of those investigators being from outside the United States.6 With more virtual worlds, we may see fewer physical site locations, but more scaled, coordinated centers with high volumes of activity.

Increased focus on diversity

While productivity, innovation and site relationships are bright areas for our industry, diversity continued to be a challenge throughout the pandemic. Disparities in the health outcomes and overall impact of COVID-19 on different racial and ethnic groups as well as the recent racial justice movements spurred renewed commitment to this important topic.

The most recent data from Tufts shows that 80% of pivotal trials for approved drugs and biologics in 2007-2017 under-enrolled Black patients, while 62% of those same trials under-enrolled Latino patients.1 Broadly, the clinical research industry struggles with general awareness, with only a very small percentage of people participating in trials. However, in addition to outreach and education, instilling a greater level of trust is unique and central to improving diversity in clinical trials. For example, in both Parexel’s Discussions on Diversity Report7 and Tufts’ research1 found that diversity in investigative site personnel was not only correlative, but predictive to how diverse the trial participant population would be.

As an industry, the more that we build trust with diverse communities, change the structural characteristics of trials, and remove practical barriers to participation, the better we can provide access to clinical research as a care option and best create treatments that best reflect the patients who will use them.

Sy Pretorius, President, Clinical Development and Chief Medical Officer, Parexel

References

  1. Tufts CSDD 2020
  2. FDA or Pharmaprjects, Tufts CSDD
  3. NIH
  4. The Avoca Group, 2021
  5. Pharmaprojects, Evaluate Pharma
  6. Tufts CSDD analysis of FDA’s Bioresearch Monitoring Information System (BMIS)
  7. Discussions on Diversity, Parexel (May 2021): https://www.parexel.com/company/diversity-inclusion