In 2020, due to the COVID-19 pandemic, clinical trials became almost a household name across the world. People realized the key role played by clinical trials in developing new interventions aimed at preventing or treating dreaded diseases. The pandemic also significantly accelerated the entire clinical development cycle. In less than one year – the vaccines underwent the rigors of clinical trials and after a thorough review of the generated clinical trials data, the regulators approved them under emergency authorization use.

All the different stakeholders came together to work with unprecedented speed – while maintaining the desired quality standards and ethics – to mitigate the unmet medical need posed by this pandemic. Within a very short time, scores of vaccines and drugs were developed and many more are under clinical development to fight this dreaded disease.

The pandemic greatly accelerated the adoption of digital technology in clinical trials. Many solutions were implemented that allowed the participation of trial participants in clinical trials from the safety of their homes. The main aims were to protect the safety of trial participants and team members and to maintain the integrity of clinical trial data. Solutions like shipping the investigational products directly to patients home while maintaining the product integrity and patient confidentiality, remote informed consent procedure, home health care nursing which included collection of blood / other samples, patient’s safety and efficacy data, are few examples.

All the stakeholders worked very swiftly to facilitate the implementation of these changes. The Sponsors quickly amended the protocols to include these elements of decentralized clinical trials so that the trial can continue while maintaining patient safety. The Regulators and Ethics committees did a thorough review of these amendments in a very short time.

Adoption of digital technology by them also significantly helped.

Thus, while the pandemic created many challenges for clinical trials, all the stakeholders adapted very quickly to implement innovative solutions for mitigating these challenges.

Looking at 2021 and beyond:

Many of these innovative solutions adopted during the pandemic, are here to stay. For e.g.,

• We are talking about #NoGoingBackToOldWaysOfWorking. The adoption of digital technology will continue to enhance since it has resulted in increased efficiency, trial data quality and speed of clinical trials.

• We are expecting that the virtual Subject Expert Committee meetings, that have been initiated by our Drug Regulator, to continue as this results in enhanced efficiency.

• The adoption of digital technology in decentralized clinical trials will significantly help the trial participants as they can choose to participate in a clinical trial from the comfort of their own location.

o They can get their investigational products at their home and so can the collection of their samples.

o They will need to visit the hospitals only for certain specific reasons.

o This makes the clinical trials more patient centric.

As we all are aware, clinical trials are key to evaluate the safety and efficacy of any new intervention. In addition to COVID-19, there are unmet medical needs for many other dreaded diseases that require newer safe and efficacious therapies. The enhanced awareness amongst public about the important role played by clinical trials in finding such newer therapies, will significantly boost the conduct of clinical trials in India so that we can fight the unmet medical needs of our patients.