While biopharma teams face increasing pressure to accelerate time to market, they also face another challenge in attracting minority participants for their clinical studies. It’s been over 20 years since Congress mandated the National Institutes of Health (NIH) to include minorities with their clinically funded research. Unfortunately, there’s been little progress with increasing the diversity of participants in clinical studies.
Trial diversity is imperative, especially as breakthrough research techniques continue to make it possible for drug developers to tailor pharmaceutical agents for a patient’s genetic makeup. However, effective tailoring requires essential data from trial studies, regardless of location, to help speed to market drugs that help minorities live healthier.
A study in PLOS Medicine Journal sheds light on the lack of clinical research on minority groups, the potential health impacts and the major barriers among trial sponsors and participants. According to the report, while roughly 40% of Americans belong to a racial or ethnic minority group, only 2% of cancer studies, and less than 5% of pulmonary studies have useful information about minorities.
Limited data about minority participants from clinical trials can be very problematic, especially if patients end up taking the wrong medications. For instance, people with epilepsy who are of Asian descent must get genetic testing before being prescribed carbamazepine, a seizure medication. Patients with a certain gene variant who take carbamazepine can severely damage their skin and internal organs.
One major barrier as to why there is limited research data among minority groups is that diverse populations often have limited access to specialty care centers that serve as referral sources for clinical studies. Traveling to and from the nearest clinical site can be cost-prohibitive for participants, which results in a lack of an effective referral base for clinical trial sponsors.
Modern collaboration solutions, such as video, help trial sponsors and participants offset this challenge as individuals can participate in a clinical session face-to-face regardless of their proximity to specialty care centers. With video, check-ins can happen more frequently with the same face-to-face interaction while requiring less demand on the participant, which increases the probability of success of the trial. Also, pharmaceutical engineers can see an accelerated time to market by leveraging video to collaborate internally with globally dispersed peers who have executed on similar trials.
MedAvante, Inc., a leading provider of technology-enabled signal detection solutions in clinical trials of treatments for Central Nervous System (CNS) disorders is an example of a company that uses video to help trial sponsors:
- Accurately determine who belongs in a clinical trial
- Establish a baseline assessment of the severity of the CNS condition the new drug is designed to treat
- Measure changes caused by the medication, and help pinpoint the potential positive effects of the treatment
For over a decade, MedAvante has leveraged the Polycom infrastructure and video collaboration endpoints, which allows clinicians to interview trial participants in an interactive, face-to-face environment regardless of location. Polycom’s reliable platform has special significance for MedAvante during the CNS trials as the quality connection helps establish and build better rapport between clinicians and participants.
“You need the intimate connection, that rapport, so subjects readily disclose to clinicians things they otherwise wouldn’t,” says Ben Barrell, video services manager at MedAvante. “For subjects suffering from severe mental disorders, a jittery video connection might be confused with a hallucination.”
The ease of use for staff and participants at trial facilities is also a major factor driving the use of video collaboration. Users simply pull their unit out of the box, plug it in, connect to a network and make the call.
In terms of improving accuracy among participants who actually belong in the trial, MedAvante conducts face-to-face interviews with subjects over the life of the trial to effectively rate how they are responding to a drug.
“Our clinicians are blinded. They don’t know what drug is under study, or who is getting the drug versus a placebo, or even the location of the site they’re calling. We’ve eliminated all these prospective areas of bias that have plagued clinical trials for years,” says Barrell.
This approach not only enables a better quality over quantity approach within MedAvante, it also helps expedite the overall process as time is not wasted traveling to and from sites for clinical trials. Ultimately, this helps trial sponsors improve their time to market of new and effective drugs to patients.
While Biopharma engineering and R&D teams face an uphill battle with accelerating time to market and recruiting a more diverse group of trial participants, location no longer needs to be a major barrier. More companies need to leverage reliable video solutions that encourage minority participants to partake in clinical research studies, regardless of location.