The Covid-19 pandemic has had a far-reaching impact on clinical trials. It jolted the world of clinical trials in a way that it caught stakeholders unaware. Digital technology came to the rescue in an unprecedented global healthcare exigency that otherwise could have significantly impacted the overall conduct of clinical trials.
One major change has been the increased use of remote and digital technologies to conduct clinical trials, including virtual visits, remote monitoring, and online data collection collectively also called the Decentralized trials (DCTs). Decentralization has been the need of the hour. Pandemic provided much needed context for decentralization. Digital technology combined with seamless interaction between the patients and Clinical Trial sites facilitated by patient facing staff especially the Clinical Research Coordinators (CRCs) ensured that clinical trials continued during the pandemic, even when in-person visits were not possible.
Avacare, delivers specialized clinical trial support across more than 90 clinical research sites in India, deploys a full time and trained Avacare employee as a clinical research coordinator to support sites. Avacare CRCs made arrangements for Sample collection, ambulance availability for SAE management, online consultation etc. during lockdowns. The pandemic saw several cases where CRCs had gone the extra mile along with the hospital nurses, arranged for ambulances and travelled miles away from the trial sites for the dosing of trial patients. Consequently, it led to high visit compliance rate2 of > 95% and >89% in oncology trials2.
The compulsions of pandemic together with patient convenience provide opportunities to leverage technology which in turn make decentralization a win-win for patients and the industry alike.
How has Decentralization influenced the conduct of clinical trials?
Inclusion: - Technology driven decentralization is inclusive in terms demographics, geography and addressing patient convenience in the bargain. It allows for diverse groups, ranging from millennials to patient population specific to trial needs, to patients who need caregivers. Patients tend to find virtual clinic visits and the facility of sample collection at home more convenient than otherwise. It can help increase the number and diversity of people willing to participate in a clinical study. Earlier, traditional trials restricted the patient enrollment within a reasonable geographic distance to ensure protocol compliance. In contrast, DCTs have no barrier of geographical distance any longer which helps include additional patients located far away from the sites. If you look at the India age demographics1, 26.2% of the population is in the age group of 0-14 and 17.5% in the age bracket of 15-24. DCTs provides a massive opportunity to tap on the patient pool in these age groups. For instance, a long-term Juvenile Diabetes trial doesn't have to suffer from the constraints of recruiting school children only from the neighborhood of site. Besides, school children migrate for higher education affecting the progress of trial.
Technology enables all the examinations, pathological and other vital measurements (Blood Sugar & BP etc.) to be done at home. The resultant data can be transferred through apps or other forms of technology in real time.
Diversity: - Decentralization makes it possible to recruit population from cities to tier 2 and tier 3 based on the need of trials. And also, population with different cultures, habits, and traditions can now be part of DCTs along with different genders and age groups. It makes for targeted and real-time recruitment.
Moreover, the tech savvy millennials will be more inclined to participate in tech driven and decentralized clinical trials.
India perspective
With 17% of world population, 20 % disease burden and a very small percentage of global trials conducted, India represents enormous potential for clinical research. Consequently, a greater number of patients will be willing to participate in trials. More patients mean more trials in India. The decentralized trial will have a centralized virtual system which facilitates monitoring of data, trends etc. from the site. It would warrant role restructuring shifting on-site role to an office equipped with remote site monitoring systems. The system would be monitored by professionals with traditional on-site skills and experience.
Decentralization will enhance patient compliance, inclusion, and diversity so critical for quantitative and qualitative clinical research in India. Patient's morale and media perspective will also change for the better.
Overall, the pandemic has accelerated the adoption of digital technology in clinical trials and highlighted their potential to improve the efficiency and effectiveness of these trials.
Key takeaways
1. The Covid-19 pandemic has had a far-reaching impact on clinical trials
2. While Pandemic in a way forced the industry to adopt Decentralized trials (DCTs), elements of DCTs were already existing before the pandemic and was gaining acceptance because of the obvious advantages
3. Digital technology combined with seamless interaction between the patients and Clinical Trial sites facilitated by patient facing staff especially the Clinical Research Coordinators (CRCs) ensured that clinical trials continued during the pandemic, even when in-person visits were not possible.
4. Decentralization enhances patient compliance, inclusion, and diversity so critical for quantitative and qualitative clinical research
5. With increasing number of trials conducted, more clinical research professionals will be needed to take up the various roles in DCTs and current clinical research professionals with experience would be needed to take up senior roles as companies ramp up their DCT capabilities
Profile of Srinivas Pai Raikar, Head Business Development Site Solutions, Avacare India, NC, USA
Srinivas Pai Raikar has more than 29 years of combined global biopharmaceutical and clinical research experience and is currently heading Business Development, Site Solutions, Strategy, and Design for Avacare India, an IQVIA company based in Durham, USA. Srinivas joined IQVIA (formerly Quintiles) as an Associate Director of Site Management in India before moving to Singapore, where he held various roles including Head of Site Solutions APAC, Head of Prime Site program APAC, and Head of Contract Sales and Medical Solutions APAC. Prior to joining IQVIA, Srinivas worked in a leadership position at Excel Life Sciences (now Avacare) and spent over 15 years at Pfizer, where his career progressed through various commercial positions.