Indian Sites Share Challenges as Clinical Trials Grow

Pratik Darji

After coming to a halt in 2013, clinical trials are once again beginning to pick up steam in India, and new study sites are reemerging. Integrated research organizations (IROs) from the West are forming partnerships with Indian study sites to provide gold-standard clinical trial operations to sponsors. With reemergence, sites face many cultural, economic, and clinical trial awareness obstacles. Dr. Pratik Darji, Head of Progressive Clinical Research Solutions in Gujarat, India, will discuss his thoughts and opinions in this interview.

Moe Alsumidaie: What clinical trial challenges do you face at the site, and how do you overcome them?

Pratik Darji: Patients face social obstacles, as there is still a lack of awareness regarding clinical trials in India and the benefits they provide to the patient and the nation.

The vast majority of people are entirely unaware of clinical trials, and for the ones who know about research, there is a fear that clinical trials would cause detriment to them. Much of this has stemmed from the clinical trial shutdown in 2013, which left a negative perception of clinical trials in India.

To address this obstacle, we begin by providing the subject with information regarding clinical trials and their benefits for the subject's disease condition. What treatment options are available to treat their disease condition? It should be made clear to the subject that there have already been earlier clinical and preclinical studies that have generated a well-understood safety profile and that the risk profile is anticipated. Additionally, patients and the healthcare system are driven by expanding access to novel therapeutics in India; hence, we discuss the clinical trial benefits the nation would get from their participation.

Another challenge with healthcare in India is economic; In India, patients attempting to overcome their disease typically opt for homemade remedies first. Because of the state of the economy, people do not usually get regular health checkups, which impacts the patient pool. To overcome this, when this patient population is interested in the clinical trial, we explain to them that the clinical trial will come at no cost to them, which tends to help recruit these patients.

A third obstacle to overcome includes culture. The people of our country observe and participate in numerous festivals and other forms of social activity. Most of the time, they will forego required study visit windows, which may impact study compliance. To overcome this, while recruiting the subject, we explain that their health is the primary priority and emphasize the significance of timely visits to the site and the subject's personal responsibility.

MA: What advantages does it offer to conduct trials in India instead of other countries?

PD: In India, we have a forward-thinking attitude and the backing of the Indian government, prioritizing patients' rights, safety, and overall health. India is also a neutral country in the current global conflict, so if anything happens globally, such as war, India would be a haven, assuming it doesn't get involved. Second, India has a sizable population, and the government is doing an excellent job of maintaining trust, which helps with recruitment. Additionally, private hospitals have infrastructure advancements, making them an ideal platform for conducting clinical trials. In addition, these hospitals have robust IT systems, which help with information access and productivity. Third, medical and paramedical staff are highly qualified and driven to perform well in their studies. And last, India has strong manufacturing capabilities to scale drug production after investigational drug approval.

MA: Are you seeing clinical trial growth in India? Where do you think it is headed?

PD: We see much clinical trial growth in India, especially in immunology. However, there is much opportunity for oncology, neurology, gastroenterology, and hepatology clinical trials.

MA: What are the advantages of forming a partnership with a western IRO?

PD: Working with a western IRO assures western sponsors that clinical trial conduct in India meets ICH-E6-R2 Gold-Standard practices. Moreover, a few practical considerations include effective project coordination, the utilization of telemedicine and translational technologies to improve multidimensional communication, the adoption of effective recruitment and retention strategies, global drug availability mechanisms, centralization of adverse report monitoring, the development of web-based common form databases, and the utilization of organizations that have established working relationships and previous experience with international sponsors.