Trial & trust: Is clinical research fulfilling its promise?

Clinical research or clinical trial sits at the nexus of human expectations and scientific evolution. A fundamental question is raised as India becomes a global centre for clinical trials.

Is clinical research actually fulfilling its potential? Is it a "weight of bureaucracy" or a "beacon of hope"? This article explores the contradictions of contemporary clinical research from the perspectives of patients, researchers, sponsors, and provides practical, human-entered solutions to close the widening gap between trial and trust.

Between hope and hesitation: Setting the stage
Dr. Meeta, a seasoned oncologist in one of government institutions in Lucknow, conducts multiple trials and a packed outpatient schedule. While she takes privilege in contributing to cutting-edge-science, the growing administrative load and lack of support often leave her drained. Meanwhile, Anil, a cancer patient participating in a clinical trial for an immunotherapy drug, finds hope amidst uncertainty but often struggles to understand what he is signed up for. Their stories intersect in a clinical trial - a miniature model of what is working and what is not.

The first question that comes up, the sponsor is gathering data to demonstrate that the drug is the best once it is on the market, the investigator is not carrying out her duties, or the patient lacks sufficient knowledge or has lost faith in the drug being studied?

India has enormous potential in the field of clinical trials because of its large and diverse population. Government of India established the New Drugs and Clinical Trials Rules (NDCTR) in 2019 with the purpose of increasing patient safety and streamlining procedures, yet the real situation continues to reflect operational challenges, site burden, participant concern, and sponsor annoyance.

Sponsor’s dilemma: Speed vs quality
Boon: For sponsors, India offers access to a large, treatment-naïve, relapsed, recurrent including rare diseases patient population, lower trial costs, and a growing ecosystem of trained professionals. Regulatory improvements are reflecting a scope for less time taking approval, making the region increasingly attractive for global clinical trials.

Bane: Sponsors, however, frequently struggle with inconsistent site performance, slow recruitment, and a dearth of real-time data analytics. Timelines can be derailed by ethics committee delays, high dropout rates, and a lack of digital integration.

Solutions
Site readiness programs: Sponsors should invest in capacity-building workshops and mentorship for investigators and site teams. It is time to avoid Virtual Site Qualification Visit (SQV)  and Virtual Investigators Meeting (IM), especially because in-person SQV allows Sponsor/its representative to understand in depth allowing site tour, chance to review EMR based on feasibility and in-person IM allows to interact with all team members (including other stakeholders) to understand the protocol and sponsor’s expectation and get an opportunity to meet with other sites team members for knowledge dissemination.

Stronger strategic partnerships: Collaborating with Strategic Management Organizations like Medivista Research can ensure efficient operations, patient recruitment and accountability.

Real-time dashboards: Digital dashboards for recruitment, retention, and adverse event tracking can offer transparency and faster interventions.

Investigators on the edge: Science or stress?
Boon: Clinical research offers investigators an opportunity to contribute to medical innovation, gain international exposure, and access advanced treatment options for their patients. It also adds a valuable facet to their professional journey.

Bane: Despite the scientific appeal, investigators face increasing administrative responsibilities, protocol complexities, and insufficient staffing. Investigators frequently serve as site coordinators as well due to lack of support, which leads to burnout and a decline in motivation.

Solutions
Dedicated clinical research coordinators (CRCs): Empowering CRCs with adequate training can free up investigators to focus on critical decision-making and further adding value to the research.

Investigator motivation programs: Non-monetary incentives, acknowledgment, and career development opportunities can help retain investigator interest.

Centralized digital tools: These tools can cut down on paperwork and save time by simplyfying data  entry, monitoring, and reporting easier.

Patients at the crossroads: Cure or confusion?
Boon: For patients, trials offer early access to potentially life-saving treatments, improved disease management, and access to expert care. In many cases, Clinical research is their sole hope for treatment.

Bane: Sadly, a lot of patients experience a sense of being passive objects rather than knowledgeable participants. Dropouts or refusals are frequently caused by inadequate consent procedures, repeated trial site visits, stringent procedures and data needs (such as diaries), language hurdles, travel burdens, and side effect anxiety.

Solutions
The PICs model: My own model - focusing on potential, interested, and comfortable doctors for referrals - ensures that patients are guided by trusted physicians who can explain the trial in familiar, empathetic terms.

Hybrid trial models:  Patients may experience less stress when telemedicine visits and in-person evaluations are combined.

Culturally sensitive ICDs: Informed consent documents should be visual, simple, and available in regional languages, supported by community engagement.

Current trends and shifts: Where are we headed?
India is witnessing several key shifts:

Decentralized clinical trials (DCTs): Covid-19 catalyzed remote trial  models. Although promising, decentralized clinical trials need patient digital literacy and a strong digital infrastructure.

AI in recruitment:  Although algorithms can now estimate a patient's suitability, human interaction is still essential.

Regulatory maturity: The NDCTR 2019 rules, compensation guidelines, and ethics committee reforms show intent - but implementation varies widely across states.

Bridging the divide: Practical, human-centered techniques to truly deliver on its promise, clinical trial must prioritize on 3T model i.e. trust, transparency, and technology:

Build patient trust: Use community health workers, patient ambassadors, and digital storytelling to raise awareness.

Strengthen site support: Equip investigators with CRCs, digital tools, and regulatory clarity.

Empower ethics committees: Train ethics committee members regularly and encourage dialogue with sites.

Sponsor-driven innovation: Move beyond protocol-centricity. Design flexible, culturally aware studies with patient input incorporated from day one.

Conclusion
Clinical trial can be either boon or bane. Like any other tool, its effectiveness is dependent on how we implement it. Patients look for hope. Investigators look for significance. Sponsors look for outcomes. We must embrace wide-ranging innovation, humanize the process, and build long-lasting trust in order to align these interests.