COVID-19 restrictions caused disruptions in the clinical trials industry bringing many ongoing studies to a halt. Sponsors started looking at ways to restart those halted studies. Home services are playing a bigger role enabling sponsors and clinical sites to reach study participants.
The home health services have been used successfully in telehealth for quite some time now. In COVID-19 like situations when patients cannot travel to clinical sites, one option for sponsors is to reach the patients at their home. The study participants make a visit to the clinical study site mainly for medication, lab work, consultation, and observations. If the sponsors can perform all those functions at the patient’s home, then the affected clinical trials can be restarted. Therefore, there is an increasing demand for such home services.
From a patient’s perspective, home health services would be convenient saving time and money. However, from the sponsor’s perspective, it brings a lot of economic as well as operational overhead and challenges. Sponsors are required to make new arrangements, partnerships, and contracts to cater to home health services to their patients. In a way, it is almost like setting up a new business model. In most of the cases, providing home services in a clinical trial setting may not be a sustainable business model. It would make sense if sponsors use home services to save the paused studies but they need to carefully avoid falling for the sunk cost fallacy trap.
From a sponsor’s perspective, clinical operations continuity is highly critical for financial cash flow reasons. A few paused studies for a couple of months would be enough to throw companies into a cash crunch, especially the ones that have a short pipeline of genuinely promising drugs. During times when every other business is exercising great constraints in cash spending, making investments in a business model that is unsustainable may prove to be a misadventure. The higher rates of unsuccessful clinical trials make decision making for executives more challenging, except for the ones who heavily rely on their gut feelings.
The home services may not be economical for large studies when there are thousands of patients and hundreds of sites spread across different countries and cities. Imagine the logistics required if we have to provide home services to such a large diverse population. Coordinating and monitoring such an initiative requires a lot of expertise and infrastructure. The sponsors would have to equip clinical sites and train the resources to provide the home services. If there are requirements to send the nurse to administer the medicine or collect samples, there would be a need for extra manpower to serve the patients in a timely fashion. For example, if we consider that a nurse can attend 5-7 patient visits in a day then the site with 100 patients would need a minimum of 3-4 dedicated nurses to complete the job in a week’s time. Considering that clinical sites participate in multiple clinical trials, maintaining a desiccated staff for every clinical trial would be impractical. Things can get complex when the patient demands more time from the staff due to their personal problems at home.
To minimize the operational costs, it makes sense for sponsors to contract with pharmacies and home health services who can provide such services on a per-visit basis. A dedicated central call center can coordinate the requests, and also help resolve queries from patients. However, such an arrangement will potentially take away much of the responsibilities from clinical sites and put it in the hands of sponsors.
Dealing with home service providers will have their own challenges. Pharmacies and laboratories mostly provide services to healthcare patients. In many cases, the healthcare home visit is covered by medical insurance and hence the services are costly. The staff is also trained for healthcare needs, and have their own priorities. Striking a win-win and cost-effective contract with healthcare home services may not be that easy. There would be a greater need to train the staff from a clinical trial perspective.
Companies providing home visit services specialized for clinical trials can fill that gap helping sponsors provide customized and reliable home services in a cost-effective way. Such survival provides can work with clinical sites on a need basis. The biggest advantage of this is that sponsors do not need to make an investment in setting up the entire supply chain. Also, sponsors get more flexibility and freedom to strike contracts with smaller specialized companies. Since the services providers are specialized, the training requirements would be low. Flexibility allows starting the study quickly.
Simply waiting for the COVID-19 to improve to resume the clinical trials may not be an option for the sponsors. Depending upon what strategy they choose, the clinical trials industry will transform itself making many existing processes and practices obsolete. Also, it will generate a demand for new business opportunities. It would be interesting to see how much of the impact on the clinical trials industry will remain permanent after the COVID-19 situation improves.
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