If a return to normalcy depends on finding a cure for COVID-19, then there needs to be a fast-tracked vaccine development process, albeit one without shortcuts. Patient participation across the spectrum of clinical development is key to this.
As of June 2, 2020, the World Health Organization’s draft landscape of COVID-19 candidate vaccines listed 10 in clinical evaluation (phases 1–3 ) and 123 more in preclinical evaluation. The gold standard for clinical trials gives the most reliable evidence and is widely used by pharmaceutical manufacturers.
Randomized, controlled trials (RCTs) are executed in four phases. From a few dozen participants recruited as trial subjects for phase 1 up to a few thousand people in an outbreak zone for phase 3, patients are critical for clinical trial execution.
As clinical trials are intended to demonstrate the safety and effectiveness of a drug, patients must be involved in the clinical research and development of vaccines that are intended for them. Patient-focused products need to engage patients at the outset of the development process.
“Patient partners can transform the clinical development process from one directed by sponsors and investigators to one driven by the needs of patients and their caregivers,” according to a study published in Applied Clinical Trials.
Telehealth has already proved its value in patient care during the COVID-19 pandemic and can be deployed to facilitate patient participation in clinical trials for the vaccine development. Communication platforms can engage and manage patient populations in clinical trials as well as in care settings.
The 1938 U.S. Food, Drug and Cosmetic Act and 1962 Drug Amendments require every pharma manufacturer to submit safety data including “...adequate and controlled studies in humans.” An innovative patient engagement platform can help produce such data, data that is instantly analyzed upon collection. Both qualitative and quantitative data from patient insights can influence outcomes and endpoints, and the data can help identify knowledge gaps if the patient-participant is engaged early in the development process.
Recruitment for clinical trials
According to Megan Molteni, a Science Desk writer for WIRED covering biotechnology and COVID-19, “Developing vaccines that are safe and effective takes time, investment, and good science. Developing a vaccine for a coronavirus like the one that causes Covid-19 comes with even more challenges.”
In phase 1 of a clinical trial to evaluate safety of the vaccine, a few dozen trial volunteers need to be tracked and monitored for 3 months. In phase 2, this time with several hundred participants, they are engaged on a daily basis to monitor any onset of side effects.
Patient-participants are ideally recruited from an area with a COVID-19 outbreak “...so scientists can gather data on how well it spurs the production of antibodies and fends off the disease for these trial subjects,” wrote Molteni. This phase 2 engagement takes about 6 to 8 months.
Phase 3 involves a few thousand patient-participants for another 6 to 8 months as trial subjects, to test the safety and effectiveness of the vaccine. Phase 4 is when major drug-licensing agencies investigate safety and effectiveness and often request further studies after a drug is approved and allowed to be marketed.
The timelines for these stages in the clinical trials depend on how fast and efficient the recruitment of patient-participants is. According to research discussed in MedCityNews, recruitment problems occur because “...complex study designs can deter physicians from referring their patients to trials, [and] patients often may not enroll due to geographical proximity to study sites, while those enrolled often drop out due to extensive protocol demands.”
A patient communication platform like LifeWIRE enables remote access to a patient-participant. It can empower pharma manufacturers to have ongoing contact and insight through secure, personalized, and automated remote dialogue in any media chosen by the patient, whether text, voice, or email.
The same research suggests that “...incorporating patient voice in protocol design can help eliminate many of these roadblocks, improving the efficiency, impact, cost, and time to completion of clinical trials.” Further, patient feedback prior to trial execution helps pharmaceutical companies minimize protocol amendments and administrative burdens.
Patient engagement at the heart
The study “Are Patients at the Center of your Trials?” points out that key to a patient-focused product, such as a vaccine, is engaging patients early and often. It’s important to keep patients engaged from screening through completion, to ask questions whose answers are important to know from the patients’ perspectives.
Around the prospective vaccine for COVID-19, there already are a lot of unrealistic expectations, such as having it by fall this year before kids go back to school. Experience with previous vaccines indicates that is impossible. But if it does happen, Molteni says that would set a record. She stated that most vaccines take between 5 and 15 years to come to market.
If drug makers and regulators want to ensure the safety and effectiveness of the vaccine, these timelines should not be compressed. Vaccines need to be extremely safe — the challenge is that it takes time and patient-participants to prove the safety.
In this stage of the vaccine development, experts are still understanding the basic biology and immunology of the SARS-COV-2 virus. That’s what patients can help bring to the table. It will take their engagement and participation to launch and complete a clinical trial — and produce a vaccine.