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The State of Clinical Research During the COVID-19 Pandemic

Clinical trials for cancer treatments make up the majority of global clinical trials — both industry (20.5 percent) and non-industry sponsored (11.3 percent).

The data from GlobalData also shows that the U.S. is the leader in terms of the number of planned trials to be initiated in 2020. Indeed, the U.S.-based trials are almost equal to all of the trials planned in the top 10 other countries. China is second, with Australia, France, Canada and the UK following in that order.

Unfortunately, the COVID-19 pandemic and race to find a vaccine means much attention will be diverted from other areas of research. Already, some trials have been put on hold.

Here we will address the immediate effects the new coronavirus is having on other clinical research and look at the disease areas that remain high focus points in current clinical research.

The Impact of COVID-19

The clinical research community is mobilizing to find a treatment for COVID-19 under the coordination of the World Health Organization. The WHO Director-General Dr. Tedros Adhanom Ghebreyesus says we need questions answered and tools developed, both very quickly, in order to bring the coronavirus pandemic under control.

The increased focus on COVID-19 means clinical trials investigating other illnesses and treatments have been suspended, says Heidi Ledford, Ph.D., senior reporter at Nature magazine. “We’re going to see a nearly complete close-down in clinical research,” Tim Dyer, CEO of Swiss biopharmaceuticals company Addex Therapeutics, tells Ledford. “The health-care systems will simply be overloaded.”

In fact, Addex has delayed the launch of its trial to treat involuntary movements in patients with Parkinson’s disease. Eli Lilly has also stopped enrolment in ongoing studies and has decided to delay the beginning of new trials, and Yale University lung cancer researcher Roy Herbst says patients are going to miss out as the development of new therapies are put on hold and cancer trials reduced.

Neglected Diseases

While COVID-19 garners much attention, other diseases continue to afflict patients around the world. Diarrheal illnesses, tuberculosis, malaria, and pneumonia have been killing people for many years and there is less urgency to find cures, writes Nick Chapman, CEO of global health think tank Policy Cures Research. The reason these diseases tend to be neglected is because they mainly affect the poor. The result is underinvestment.

Nevertheless, there is cause for optimism. Policy Cures Research tracks every dollar spent on treating neglected diseases. Results show that 200 public, private and nonprofit funders are investing in treatments for neglected diseases. In fact, funding is at a record high of $4 billion after three years of sustained investment in research and development.

Notable recent successes include “the first new treatment for river blindness in 20 years, a game-changing oral treatment for sleeping sickness, a single-dose cure for relapsing malaria, and new vaccines for diarrheal illnesses and pneumonia.” Plus more than 500 drugs, vaccines and diagnostics tools are currently in development.

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Cancer Clinical Research

As of November last year, there were some 16,000 active clinical trials in the U.S., in addition to 2,000 recently completed studies. Rachel Grande at Definitive Healthcare points to the statistics from the National Library of Medicine, which marks 2019 as the year with the highest number of trials recorded since tracking began around two decades ago.

Cancer research is at the top of the chart in the U.S. Over the 20-year period, there have been more than 360,000 cancer trials, and cancer clinical trials are projected to have a 2022 market value of $100 billion, Grande reports. There were also 30 FDA approvals of new chemotherapeutic drugs as at November 2019.

Heart Conditions

Investigations into heart health remain an important focus of current research. This is a combination of new therapies and reappraising what we thought we knew, explains Maria Cohut, Ph.D. at Medical News Today.

She refers to a study of 1.3 million people that suggests both blood pressure numbers — diastolic and systolic — are equally meaningful predictors of a patient’s heart health. This marks a shift from previous thinking that an elevated systolic reading was the main risk for cardiovascular disease.

Metabolic Diseases

There are exciting collaborations happening in the metabolic disease research areas. For example, AstraZeneca and MiNA Therapeutics have partnered to “evaluate whether small activating RNA (saRNA) molecules could be effective in treating metabolic diseases,” writes Hannah Balfour at European Pharmaceutical Review.

Robert Habib, CEO of MiNA, says that there are currently insufficient treatment options for metabolic diseases. Greater focus on discovering the underlying causes of metabolic diseases will be a boon for patients.

Psychiatry and Neuroscience Clinical Research

This year will also be exciting for researchers working in psychiatry and neuroscience. Mark Opler, Ph.D., chief research officer at WCG MedAvante-ProPhase, says it will be about building momentum on the successes of the past decade.

Researchers should expect more FDA approvals of new therapies for mood disorders. He notes esketamine and brexanolone, which Opler argues, show signs that central nervous system clinical research will continue to be prioritized.

A positive sign is that there are ongoing trials investigating conditions such as PTSD, schizophrenia and rare neurodevelopmental disorders. Opler says digital therapeutics are helping researchers to innovate in these disease areas but placebo responses continue to negatively affect current research.

Clinical researchers in psychiatry and neuroscience should focus on doing what they can amid cost rises and more complex research. Technology will be a great tool but what is clear is the need for stakeholder collaboration.

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Rare Diseases

Rare diseases in the U.S. are defined as those affecting fewer than 200,000 people. Roughly 30 million Americans suffer from 7,000 rare diseases.

Yet treatments are few, which is why the FDA is spending $15 million in grants over the next four years for research into products and treatments for rare diseases under its Orphan Products Clinical Trials Grants Program (OOPD), writes Jessica Kent at Healthcare IT Analytics. The program is funded by Congress and clearly signals a focus on finding “drugs, biologics, medical devices and medical foods to treat rare diseases,” she explains.

Disease focus areas include a genetic disorder that causes muscle loss, Duchenne Muscular Dystrophy, in addition to “sickle cell disease, a group of inherited blood diseases that can cause anemia, infections, and strokes.” Investment will go into enrolling more children into trials to find treatments for brain and eye cancers that affect young patients.

The OOPD, which launched in 1983, has spent in excess of $400 million to fund more than 600 new clinical studies, according to program director Janet Maynard, M.D..

In addition to government funding, pharma organizations including Novartis, GlaxoSmithKline, and Pfizer have embarked on studies to treat rare diseases. Mergers and acquisitions over the past few years points to the reason contract research organizations are changing the scope of their businesses, which is to accommodate trial sponsors’ shifting demands, writes Carol Dhillon at Results Healthcare. Increasingly, CROs are looking to cater to niche services. One example is Precision for Medicine’s acquisition of rare disease CRO Agility Clinical.

Precision Medicine

While not a specific disease area, current clinical research is focusing too on the development of precision medicine. Essentially, this means that each patient is treated as an individual, write John Whyte, M.D. and James Gillespie, Ph.D. Researchers in precision medicine focus on the relationship between disease-specific and patient-specific factors, as well as environmental and sociocultural, quality of life and functionality considerations.

Precision medicine research begins with a therapeutic hypothesis, followed by finding out which patients respond and why, looking at biomarker responses. Researchers also investigate subpopulations, in an attempt to identify patients with a particular shared gene that are most responsive to a particular treatment option.

Whyte and Gillespie say that precision medicine is well suited to “epigenomics, metabolomics, pharmacogenomics, and proteomics.”

The COVID-19 pandemic may have caused research into other areas to slow down but much optimism should be drawn from the above. Cancer continues to garner support and funding, and neglected and rare diseases are increasingly coming under scrutiny and new ways are being sought to treat patients that suffer from them. This is good news for clinical research and even better for patients.

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