Recent talks about the clinical trials for the Corona vaccine got me interested in the procedures of clinical trials.

and the extent to which technology is a part of this. For someone who comes from a pure technical background, understanding and exploring the field of pharmaceuticals and clinical trials has been an interesting journey which I would like to share in this blog post

What are Clinical Trials?

The making of a remedial drug/treatment for a disease or anomaly is a procedure that consists of several phases. Clinical trials are the third phase in drug development. The first two being discovery/development and pre-clinical research.

When there is a new drug or treatment identified for a particular condition, the researchers have to further study its effects on humans. Clinical trials are the primary method by which researchers evaluate if the new drug/treatment/medical device works as effectively as intended.

Clinical trials constitute the most critical part of the drug’s development and they are also expensive.

How are Clinical Trials conducted?

Clinical trials are conducted in different phases. In all the phases, there are a certain number of human participants. The participants are subjected to the drug in focus and are continuously monitored by the research team. The participants are also expected to provide the desired information to the research team.

As we can see, there is a lot of regular data exchange between the participants and research team. When there is data, there needs to be some technology

Challenges at Clinical Trial Operations – Technical Solutions

Participant enrollment

Usually, the participant group would be from geographical locations around the centre of clinical trials. Sometimes when the number of enrolled participants do not meet the planned numbers, it becomes necessary to recruit participants from other parts of the world. In such scenarios, digital technologies like  Electronic Informed Consent (eICF), Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA) help in increasing patient enrollments

Global Clinical Research

In some cases, it becomes necessary for research organisations to conduct clinical trials with participant groups spread over the entire globe. These are called decentralized clinical trials(DCTs) or virtual clinical trials. Here the participant need not visit the clinical research centre. The communication with the participant in this method is heavily dependent on technology. Logistics of drug delivery, routine collection of data and monitoring of patient healths can all be done remotely, thanks to digital technologies

Consent

Regulations laid by countries require the participants of the clinical trials to record their consent to be subjected to the process.At present, the process of obtaining  consent from participants is a paperwork intensive process. Since the participants can withdraw their consent at any point in time of the trial, maintaining the consent documents also becomes a tedious process for the research group. In this context, digital technology can play a major role in easing out the operations. Tools like eICF can be employed for easy record keeping and maintenance. 

Funding

When the research scholars at universities are not completely funded for the research, they can use online tools to raise funds for the clinical trials from the general public. Having an online tool will ensure transparency and security of the finances.

Communication among study personnel

In several instances, the research body would have to broadcast messages to its participant group. Having a dedicated website is very useful for this purpose. This website can also act as a forum for discussion where the experts can address the concerns of participants. Additionally, the website can also be integrated with a secure and encrypted communication channel where the group of researchers can talk to each other.

Randomization

The protocol for clinical trial necessitates dividing the participants into two groups. One group will be given the actual drug whereas the other will be given a placebo. Both the groups will not be informed whether they have received the actual drug or placebo. To avoid selection bias,the division of the participants into groups can be done by digital tools. There on, the progress can be tracked by these tools knowing which category the participant belongs to.

Why should Clinical Trials adopt technology?

The participant group for a clinical trial will be large and spread across the world in various time zones. The continuous inflow of data would be huge making manual handling an impossible feat. Hence, it is necessary to do basic data processing with software tools.

For pharma companies, clinical trials are an expensive phase. The outcomes can make or break the reputation of the company as well as its financial standing. So, in order to ensure that the process is in accordance with the plan and for ease of operations, it makes sense for pharma companies to adopt relevant technologies as much as feasible. When it is not possible for pharma companies and other research bodies to have an in-house software team, the work can be easily outsourced. Consultants like Pace Wisdom are experienced in integrating technology to clinical trials.

Best suited technologies for Pharma Industry

1. Blockchain

Blockchain can be adopted in clinical trials for ensuring transparency of  the process as dictated by the country’s regulations. Other integrations of blockchain in this field can be in the form of smart contracts or for the identity protection of participants. Source

The implementation of this technology is still in a nascent stage and holds a lot of scope. 

2. Artificial intelligence and Machine learning

Attempts are being made to employ machine learning for identifying erroneous data coming with the data coming from participants. However, these technologies have the potential to be commonplace in clinical trials. Source

Conclusion

Clinical trials should comply with the regulations laid down by the concerned body in the countries they are conducted in. Protecting identities of participants while disclosing the outcomes of the trial is of paramount importance for pharma companies. Technology can help pharma companies to comply with the aforementioned conditions easily, in addition to doing the usual operations on data like filtering, performing plausibility and drawing conclusions.