The COVID-19 pandemic has caused disruption to clinical trials around the globe. Although, sponsors, CROs, clinical trial sites and other stakeholders are continuing their crucial work. But the question is Is COVID-19 Impacting Clinical Trials in India?
Novel coronavirus impacted on patient recruitment for new trials and to keep already-enrolled patients compliant with their study scheduled visit.
Site closure, pausing site initiation and monitoring visits, patient retention is triggering towards disruption. This represents a global disruption to traditional onsite clinical trials.
India is also facing the same situation. For that reason, finding alternative solutions and using innovative approaches are critical at this point. The U.S Food and Drug Administration (FDA), the National Institutes of Health (NIH), the European Medicines Agency (EMA), China’s National Medical Products Administration, and several other countries have issued guidelines concerning the conduct of trials during the pandemic, and are fully supportive of incorporating virtual services.
These services include options where one or all patient visits don’t happen during a clinic or hospital, but rather reception.
Clinical supply chain and logistics companies are working hard to help and prevent pharma. As well as biotech companies from postponing or delaying clinical studies. They are providing patient-centric delivery services and biological sample shipments.
Over the course of this, India sites concerns about patient willingness to continue in clinical trials for which they are already enrolled. This may negatively impact clinical trial enrollment.
Clinical Trial sites are facing serious staffing issues. Employees experiencing difficulties working from home or are not fully engaged due to COVID-19.
CROs and Pharma should adopt the technology.
Direct-to-patient (DTP)/direct-from-patient (DFP) services
Few of the pharma and CROs have adopted DTP/DFP in India. This can solve challenges with reference to lockdown, site closings, patient protection, and site staff. Resolutions, such as DTP, can keep clinical trials going and patients safe by making it possible for those patients to have treatments. In some cases, diagnostic tests shipped directly to them at home. DFP services, biological samples can be retrieved from a patient’s home to be sent to central and specialty laboratories for testing.
The integration of DTP/DFP into clinical trials during this pandemic also includes the use of tracking technologies that can provide patients with updates on home deliveries and pick-up.
Real-time updates on the driver’s information, such as location and predicted arrival time, shipment number, and delivery address, allow patients to have more visibility with regard to their role in the supply chain process and can help improve protocol compliance.
Moreover, providing a dedicated home health care (HHC) program, where a healthcare professional goes directly to the home, can help make participation in clinical trials as easy as possible for patients.
A global network of providers can offer skilled and flexible services, including administering a therapy, performing a checkup or taking samples.
Shifting protocol design now to include DTP and home visits will not only mitigate risks during this pandemic, but also will most likely become a standard clinical protocol, whenever possible, moving forward.
Clinical Trial industry is low to adopt the technology. Indian CRO and pharma should discovering the solution.
Planning for the long term is necessary. Currently, pharmaceutical companies are losing weeks of precious time, waiting for the necessary approvals to add these services to their protocols during the ongoing crisis.
We cannot predict when clinics and hospitals will recover to a normal state. Therefore, planning beyond the next two or three months, and even throughout 2020, will help to minimize disruptions. Shift to technology before launching new trials.
Planning for change
Historically, the pharmaceutical and biotech industries have often taken a conservative stance to drug development. But, in times of uncertainty, there lies opportunities for rethinking processes. To reduce disruption to clinical trials, it is the role of the supply chain solutions company to increase transparency and work with pharma companies and CROs to create a mitigation plan.
Not having a plan in place could mean losing enrolled patients, resulting in having to restart a trial, which could add years to a drug’s development. That’s why thinking a step ahead is crucial and begins with observing what other countries are experiencing, and applying these efforts across a program.
Each day a drug or product is delayed in clinical development translates not only to lost revenue, but more importantly, to postponing novel therapies in their journey to the patients who need them most.
Question is still there, will COVID 19 have long lasting on how clinical trials is conducted?
Approch city based CRA/CRC to be train as CRA
CROs and sponsor should approach regional CRAs. Many of industry has accepted this change as revolution to control the disruption.
I wrote this article in Jul 2020 and published on the same website. Although due to maintance, I am publising in Sep 2020.
Thank you for reading my article. Reach out to me if any query.
Content Writer : Shahenaz Karadesai