Real World Data and Evidence: The Future of Indian Clinical Trials

Let's know about the emergence of Real World Data or Evidence for drugs clinical trials

Traditionally, randomised clinical trials or RCTs have been considered to be the gold standard for measuring the safety and efficacy of drugs. The data obtained in the controlled setting that a good RCT employs provides the best evidence of the efficacy and safety of the drug with little contamination by other factors.  Lately, though, the emergence of Real World Data or Evidence (RWD/E) has allowed us to evaluate the safety and effectiveness of medicines in real-world settings, and there is an of interest now in evaluating if RCTs can be augmented by RWD/E leading to faster and more efficient drug development

What is RWD/E? How can it help?

RWD is data relating to patients' health status and or the delivery of healthcare routinely collected from a variety of sources. RWD/E can be derived from electronic health records (EHR), claims and billing, health registries and surveys among others. In addition to this, various hybrid or pragmatic trial designs and observational studies can also generate real-world evidence. On the other hand, RWE is the clinical evidence regarding the usage and potential benefits, or risks of a medical product derived from analysis of RWD, thus becoming actionable when backed by analytics and artificial intelligence.[i]

RWD/E hold great potential to improve patient outcomes since they help derive deeper insights from actual practice beyond what the traditional clinical trials can produce. Thus, RWD/E enables the researcher to link the insights to newer sources and opportunities, improve overall trial outcomes and thus make informed decisions. RWD/E can also help stakeholders across the ecosystem in varied ways –life sciences companies can understand how their drug is being used, healthcare providers can improve the delivery of care, and regulators can monitor post-market safety and adverse events.  RWD/E studies could also be the option to go to when running an RCT is impractical and/or when exposing more patients to the standard of care would be inappropriate.

In addition, RWD/E can reduce drug development costs by serving as an external control arm, removing or reducing the need for control arms within the controlled clinical trial itself.  There are many examples of regulatory filings that have used the RWD to augment clinical trials and thereby reduce the time/cost of the trial.[ii]

Real-world evidence studies are also conducted to meet the expectations of insurance agencies, patients, and regulatory authorities. These studies can enable better reviews of pricing, reimbursement, licensing of new therapies, and more.

What is the way forward for RWD/E in India??

A large amount of healthcare data is generated in India from government-private hospitals, primary health centers, and health insurers. However, as a nation, there are challenges with standardising real-world data and leveraging these insights to their full capacity including:

• Availability of Electronic Medical Records (EMR): Only a handful of private or corporate healthcare providers have been able to implement the use of EMRs. However, the usage has not been to its full potential. A large chunk of these records is still hand-written by the medical professionals and support staff, making these records inconsistent. Moreover, firms may be incomplete as patients may not fill out the entire form.

• Quality of Data: RWD/E is significantly dependent on the quality of available data. In India, there is a lack of robust data collection methods and structured databases. A critical issue is the high doctor-to-patient ratio in India, where doctors are burdened with a large number of patients to diagnose on daily basis. As a result, doctors are unable to spend adequate completing information for medical records.

• Lack of Medical Compliance/Follow-Ups: In the search for second opinions, patients tend to visit and consult more than a single doctor, leading to a lack of continued medical surveillance. Currently, there is no way to determine if the data provided by these hospitals are of the same patient or multiple patients. Due to this reason, it is often challenging for healthcare professionals and administration to maintain a thorough, consistent record of the patients' journey. It also leads to the duplicity of records adding to the burden of inconsistent medical records – both physically and digitally.

• Insurance and Claims Data: Medical claims in India are inadequately used to understand healthcare research and outcomes. Nearly 30% of Indian adults have no health insurance coverage.[iii] Furthermore, our medical insurance claims do not cover outpatient visits or day consultations, thus limiting data to only hospitalizations, surgeries or serious adverse events. These limitations add to the burden of scattered data, thereby reducing the possibility of achieving comprehensive results when looking at real-world data.

Therefore, despite its advantages, India is at a nascent stage and there is a long way to go to be able to successfully leverage RWD/E. However, there are an increasingly larger number of efforts to try and leverage RWD/E in India to its full potential.  Some of these include:

• Patient Registries: These hold great value in epidemiology and research. They can help us collect information on individuals with a particular disease, follow their progression, and document patient experiences. In some cases, it can also be used as a surveillance tool to monitor the quality of care and safety, sometimes specific to a disease or therapy area for deeper insights. In India, the National Cancer Registry is a good example and starting point to leverage real-world data.

• Leveraging Digital Healthcare:  For a diverse population, digital initiatives like National Digital Health Mission and National eHealth Authority can aid in the integration and interoperability of data. These would allow all stakeholders, especially healthcare providers a complete understanding of the patient's journey and enable quality care for all.

Regulatory authorities in nations across the world have realised the immense potential of RWD/E in improving healthcare and India is not far behind. Small, but critical steps are being taken towards harmonising RWD sources through a collaborative effort – Ayushman Bharat Yojana, and National Digital Health Mission to name a few.

Having said that, India's journey in this space is going to have to be a long and patient one. We will need to continue to be disciplined about collecting all the right data all the time, standardizing our data collection instruments, and expanding the coverage and scope for medical insurance.

Author:

Mahesh Iyer, VP, GDO India Head & Innovation Lead, Parexel