Before Covid-19, the classic clinical trial was very much an in-person process. Drug companies, or the contract research organizations (CRO) hired to run the studies, recruited investigators and patients. Those patients physically entered a clinical site to receive the experimental treatment, and they returned for follow-up visits to assess how they’re responding to the medicine. Covid-19 showed how technology can upend the old ways of clinical trials. It has also highlighted the importance of improving clinical trial diversity so that tests of new therapies and vaccines reflect the population of patients that they will treat in the real world.
The lack of diversity in clinical testing has been a persistent problem, according to Allison Kalloo, founder and president of Clinical Ambassador, an organization that helps the life sciences industry diversify study enrollment. She noted that Drug Trials Snapshots, the FDA database that provides demographic data on clinical trial participation, shows that for roughly 75% of drugs approved by the FDA, there are not enough data from minority participants to be statistically significant. She added that the figures are a glaring shortcoming considering that most drugs approved are for diseases in which minorities are overrepresented.
“No other set of facts underscore the need for a reckoning in clinical trials than these data,” said Kalloo, speaking during an April 22 panel discussion about clinical trial diversity at MedCity News’s INVEST conference. “These data measure the response of industry to health disparities. This disconnect makes alarming predictions, if unchecked, of the capacity of the healthcare system to respond adequately to patients of color.”
Drug companies and CROs see several barriers to recruiting underrepresented groups to clinical trials. Doug Langa, executive vice president of North America operations and president of Novo Nordisk Inc., said that in some cases, travel time or finances pose a burden participating in a clinical trial. Novo Nordisk has been trying to expand its reach to diverse communities by working with patients and patient advocates. Langa added that clinical visits can be made more accessible by being placed at sites in trusted locations, such as places of worship.
Langa, who also serves on the board of the Pharmaceutical Research and Manufacturers of America (PhRMA), said the trade organization recently published its first ever principles on clinical trial diversity. Those principles include building trust, reducing barriers to access, using real world data, and sharing successes and failures.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Trust, or the lack thereof, is a big barrier, said Cynthia Verst, president, design and delivery innovation for research & development solutions at IQVIA, a CRO. One way to rebuild that trust is by improving the diversity of the investigators, she said. She added that IQVIA is moving away from having clinical trials run solely from academic medical sites. Studies are now being established in communities where diverse patient populations are located. Some aspects of a study can be done in the community, perhaps a pharmacy or an imaging center, said Carrie Williams, vice president and partner at McKesson Ventures. Some parts can even be done from home.
Clinical trial capabilities were already extending into the home even before Covid-19, but the pandemic’s clampdown on clinical trials last year sped up the adoption of technologies that are making decentralized clinical trials possible. Langa said Novo Nordisk has invested in wearable technology that can provide some of the patient monitoring that an investigator would do. Williams noted that telemedicine now allows clinicians to consult with patients remotely and that electronic consent (eConsent) permits patients to review clinical trial documents from a digital device anywhere. But she cautioned that in embracing technology, the industry can’t lose sight of the human element of clinical testing. Some patients may prefer that someone sit with them—in person.
Ambar Bhattacharyya, managing director of Maverick Ventures and the moderator of the panel, recalled being pitched by a company that allowed patients to rate their clinical trial experiences. Some of the feedback pointed the way to practical solutions. In one instance, a patient said that the clinical trial site closed at 4 p.m. and if it were open until 5 p.m. that person would be able to make it. Another commented that the parking was quite far, and a valet would be helpful.
Kalloo said that transparency is key to building trust. In virtually every aspect of our lives, people can offer online feedback on the places where they eat and the services that they use. If patients could offer feedback on their clinical trial experiences, it would help to keep the industry open, honest, and transparent, she said.
“Having eyes on this process confers piece of mind,” she said. “How can it not?”
Photo by Flickr user Wonder woman0731 via a Creative Commons license
