Applied Clinical Trials
CEO of Firma Clinical Research, Michael Woods, shares why COVID-19 may force greater efficiency for trial designs and greater access for trial participants.
The COVID-19 crisis is not going to last forever, but its impact on clinical trials may. Future clinical trials that have the best chance to proceed may be those that decentralize and effectively engage with patients. In this interview, Michael Woods, CEO of Firma Clinical Research, shares why COVID-19 may force greater efficiency for trial designs and greater access for trial participants.
Moe Alsumidaie: What does the future of successful clinical trials look like?
Michael Woods: I believe COVID-19 challenges will force the industry to design trials with greater efficiency and greater access for trial participants. That will involve a variety of patient-centric solutions to enhance recruitment, retention, and the entire trial experience for the participants, including home health visits and technology, to support more remote access. A significant change will be listening to the patient's needs with greater focus.
Trials that adopt decentralized and patient-centric approaches will simply be more competitive in attracting research participants. I believe the patient-centric changes will happen quickly, as will the more rapid collection of data to support the development of a drug or device. Those who fail to adapt will suffer a competitive disadvantage.
MA: After COVID-19, fewer patients are willing to go to study sites. How do patient-centric approaches help to recruit and retain these participants?MW: Home health visits can lower risk and make it easier for a research subject to participate because there's no negotiating going into a doctor's office, clinic, or hospital, where the perceived risk is often far higher. A home health visit occurs with personal protective equipment, and social distancing to minimize the risk of potential COVID transmission. A nurse or phlebotomist communicates in advance with each research participant to ensure visit expectations are understood and to gain the risk perspective of the participant. When you have participants at higher risk – the elderly, pediatrics, rare disease populations – there is an ease and safety advantage to have the research come to them.
MA: What types of studies are most appropriate for at-home health services?MW: Home health services are appropriate for participants with compromised mobility or underlying conditions. Rare disease populations often live far from research sites, so easing the travel burden for those populations is a huge advantage. And if there are conditions that are somewhat caregiver intense, it's much easier for the research participant to be seen in the home rather than having the caregiver coordinate transport to a clinic or hospital.
MA: How can sponsors expand access to research by employing home-health services?
MW: There's no question that home-health services can extend the reach of a site by hundreds of miles and save the participants a great deal of travel. One of the biggest challenges that we hear from sites is that subjects don't want to travel or express concerns that the subject stipend they receive is not enough to cover travel expenses. By deploying home health nursing, sponsors can not only expand a site's reach to remote locations but also retain these patients. The key to operationalizing this is to deploy and train home health nurses who are local to the research participant.
MA: Tell me about the more complex procedures that need to be conducted at home.
MW: That comes down to the amount of training available to home-visit nurses and what is required to support a specific procedure or collection of a data point. If it involves equipment that is easily transported into a home, like an infusion pump or a centrifuge for spinning down blood, that lends itself to home visits. Mental health assessments and scales that are used for behavioral analysis can be administered by home health if the nurse is trained to apply those tools. You also can combine the nurse visit with telemedicine. A physician or other study staff member can conduct assessments virtually, with the nurse in the home also simultaneously collecting data.
I believe we will see an increasing number of procedures being conducted in the home, as equipment that supports those procedures improves and becomes more mobile. Also, as telemedicine technology is growing and it becomes more widely used, I think you will see more dedicated research resources in the home setting. This mirrors what I expect to see in healthcare in general.
MA: What clinical trial training requirements do home-health nurses have to undergo?
MW: All nurses should be experienced in administering health care procedures in the home. A typical home visit to support research includes the collection of blood, body fluids, or other biological samples, a general or specific physical examination and the collection of vital signs. Additionally, nurses should be trained on protocol-specific procedures, including sensitivity to the research subject's condition, such as mobility or mental state. Training should also include GCP, and all training documentation must meet the satisfaction of the overseeing investigator, CRO, or sponsor.
MA: How could sponsors differentiate between a general home-health nursing service vs. a clinical trial-specific home health nursing service?
MW: Sponsors should look for home health services that focus on the relationship between health care professionals and the research subjects. It involves strong communication to manage that visit and the human interaction and to make it a relaxed, comfortable experience for the research participant. An excellent home-health nursing service focuses on the research subject, having a positive experience, and then use that feedback to refine service delivery approaches continually. In other words, it is not enough to simply be a referral service that calls up a home health nurse to collect the blood. Home-health services need to tune into what the research subject's needs are and tailor the service to those needs.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.