Clinical Intelligence Analytics - Summary

Clinical Summary Dashboard

Summary Dashboard gives an overall picture of clinical trials in a summarized form at a high level. 

Below (Figure 1.1) is a picture of the dashboard without any data filters. If I make any selection or filter, I will call it out and mention it.

Figure 1.1

The Dashboard tries to answer some basic questions to start with, and then we start looking at things from different angles and dimensions. 

The summary Dashboard can answer some of the following questions:

1. How many studies have been registered so far in the US?

This the total number of studies registered in the database. As on 09-Aug-2019, there are 313,345 studies registered in the US.

2. How many studies did actually started?

A study is considered to be started when it enrolls its first patient. It's an important milestone in the entire clinical trial process. 291,364 out of 313,345 which is around 93% of the studies did actually start by enrolling a patient.

3. How many studies did actually completed? 

Another important milestone is when a study completes and the patients who participated in the study stops receiving the drug. Of the 291,364 studies that started, 167,511 studies were completed, which is 58%. 

4. For how many studies did the sponsors posted the results?

Once the study is completed, the data collected is analyzed and the results are posted. Results Database was initiated in 2008 whereas the study registration began in 2000, so there might be studies without posted results. 38,127 studies have results posted out of 167,511 completed studies which is 23%.    

5. How many studies are currently recruiting patients?

A study recruits patients as study facility location called study sites. These study locations could be in many countries. 54,968 studies are presently enrolling patients including the ones that are enrolling only by invitation. This means 19% studies of the 291,365 studies that were started are still recruiting patients. 

6. How many patients were recruited in the past?

There were few enrollment values such as 99999999 that were converted to 0. About 490 Million people participated in the clinical trials across the globe from 210 countries. As per the recent United Nations estimate, the would population is 7.7 billion. We can say that 6.4% of world population has participated in clinical trials of the US. Other countries may have their own clinical trials registry.

7. What is the average duration of study completion?

Duration is the difference in the start and completion date of the study. 2.62 years is the average duration for a study to complete. Phase 3 trials are large scale studies and takes longer than phase 1 and 2, but we will look at that later. We can say that it will take around 8 years for a new drug to complete all the phases of clinical trials before it can apply to FDA for approval. Add another year or 2 for pre-clinical testing of the drug on laboratory animals. Now I understand how lengthy, complex and risky is the entire process of drug development. I will not go into the drug pricing strategies but you got a sense why those drugs are so un-affordable, even with insurance sometimes.

8. How many total sponsors registered the studies?

28,068 sponsors from both industry and non-industry (government agencies etc) have registered studies. We will see the ratio and proportions later.

9. What share of registered studies were interventional or observational?

Almost 80% of the studies are interventional studies where some kind of therapy is given to the participant.

10. What percentage of registered studies were sponsored by industry and non-industry sponsor?

Non-Industry sponsors leads with 3/4th of studies sponsored by them.

11. Top 10 sponsors who registered the most studies?

GSK is the leader. Pfizer and Astrazeneca are other sponsors from pharmaceutical industry following with a close margin. National Cancer Institute, a non-industry sponsor, is at a second position. 

12. What are the top medical conditions for which the studies were registered?

Surprised to see obesity at number 2. Asthma and depression are in top 10. I never thought they were so important but I guess our lifestyle changes are responsible for their growth. Breast cancer is the most studied medical condition.

13. What is percentage share by the overall status of the study?

Only a small portion of the studies were withdrawn and suspended, however, 5.65% studies were terminated which could be a cause of concern.

14. What are the top 10 countries that recruited the patients?

US has recruited about 18% of the total participants. 

Taiwan at no 2 surprised me. I found it enrolled around 67 million participants for an observational study but Taiwan's total population is around 25 million. The enrollment number is an outlier to me, however, I did not change it. Cambodia too has a study that enrolled 15 million participants for an observational patient registry sponsored by non-industry sponsor French National Institute. 

Since observational studies enroll large population of participants, let's look at who are the top countries who recruited for interventional studies only (Figure 1.2). Almost 82 million participants have been enrolled so far and US once again leads the chart with a contribution of little over 13% and China closing the gap at second position.   

Figure 1.2

You can always slice and dice the analysis to look at things from different perspective in a dashboard. It's real fun to create your own questions in your mind and then try to find out the answers yourself.

See you till next time.

Clinical Intelligence Analytics - Insights

Clinical Trial studies a new drug or device before it is brought to the market. The new therapy is tested on human subjects to evaluate its safety and efficacy.
Sponsors or investigators of certain clinical trials are required by U.S. law to register their trials on and submit summary results to ClinicalTrials.gov website. 
While working for a CRO as a Business Intelligence and Data warehouse Engineer, I gained some basic knowledge about the Clinical Research. I got so much interested that I decided to study Bio-sciences Management and Analytics subjects in my graduate MBA program. Unfortunately, my curiosity and the desire to learn more about Bio-sciences did not end there. 
I am passionate about creating insights out of data and I always try to unravel the layers of my curiosity by diving deep into the data. So, I decided to get the data from ClinicalTrials.gov and create Clinical Intelligence Analytics for myself. Here is the link in case you want to download it too.: https://aact.ctti-clinicaltrials.org/
The objective of creating this application is to share the insights with the community so that they know more about the things happening in this space. I would be really happy if this application could be of any benefit to patients, physicians,sponsors and other partners of the ecosystem. There are few online websites that helps patients find the recruiting study. However, I did not find any easy way that can help patients find out more about particular studies or sponsors or investigators in the past so that they can make informed decisions.
I used Talend software to get the data and used Qlikview BI to do data preparation and to create analytic dashboards. I have created more than a dozen dashboards so far and creating more as we go along. 
I would appreciate to leave a comment if you read the posts and find it useful. 
Since I do not want to make the posts boring for readers by putting a lot of information in one single post, I would be posting multiple posts in a series in coming days and update the link below in this post.

1. Clinical Summary Dashboard
2. Growth Trends Dashboard

Here are few links that would help in understanding basic terminology and basic information on ClinicalTrials.gov:
Common Terms
Trends Charts

Blockchain for Healthcare and Clinical Trials

Blockchain for Healthcare and Clinical Trials by Manohar Rana

The article is based on our 3rd place winner's proof of concept presented at Generation Blockchain Challenge.

          In general, healthcare and clinical trials are complex business environments mainly due to its direct impact on the human lives and various regulations built around them. There are various stakeholders in the entire ecosystem, and the need to improve on how these stakeholders collaborate and communicate with each other is ever increasing. Technological advancements from time to time have made significant improvements, but due to slow adoption of these technological advancements in healthcare in general, there is a great potential for newer technologies like blockchain to bring significant improvements in the overall systems.
          Healthcare organizations have made significant improvements through technological and process innovations that have benefitted and improved the entire customer experience. The most important customer in the ecosystem is a patient, and the entire healthcare business is centered around this customer. The ultimate aim of the various players like physicians, clinics/hospitals, pharmacies, drug manufacturers (pharmaceutical companies) is to bring value to a patient and enhance the overall customer experience. Then there are regulatory bodies like Food and Drug Administration (FDA), that oversees all these players, ensure the rights of a patient are protected and that they not misused in any way. A patient is the end consumer of the benefits in the entire value chain.
          On the other hand, in clinical trials, the drug manufacturer companies actually partners with human subjects aka patients to try their trial drugs on them before they bring the new drug to the market. Some of the key players in the clinical trials process are the Pharmaceutical company or the drug manufacturer, Contract Research Organisation (CRO) and Site Investigators (Physicians). Institutional Review Board (IRB) act as a regulatory body under the FDA. Since the other actors in the ecosystem are organizations that have their own technological infrastructure, the subjects remain at the receiving end. They have a limited role to play in the entire process and is limited by the technological capabilities of other's systems. Regulatory requirements make Organizations business systems slow, complex and inflexible. Generally, both healthcare and clinical trials partners have greater needs to collaborate and share the information through these complex systems.
          Attempts are made from time to time to come up with centralized systems that can facilitate greater collaboration and quick information sharing, but such systems pose their own challenges of ownership of data. Integrating data from different systems owned by different parties is a challenge. One alternative way could be to try to connect the trusted parties that are known to each other on a common platform. Blockchain technology has the potential to play that role. It may be too early to predict what role blockchain can play since there are not enough use cases that are being tried upon. It is difficult to say if Blockchain can displace the existing systems completely or complement them for some time before it actually does that. The objective here is not to speculate that possibility of whether Blockchain is a replacement for traditional Clinical Trial Management Systems but to explore the possibilities of small use cases that can actually bring value to the entire ecosystem.
     
Before we discuss how Blockchain can play an important role in clinical trials, it is important to understand the current challenges in the healthcare and clinical trials.

Few of the challenges in clinical trials are:

1. Subject Recruitment: To ask and convince a healthy subject to try a new trial drug is a challenge. There could be different motives for a healthy person to take that risk for monetary or personal reasons. Sponsor's find it very difficult to identify and recruit ideal subjects. A lot of times, the self-reported information provided by subjects cannot be authenticated leading to issues like dual enrollment, false disclosures, higher screen failures, a potential risk of severe adverse events (SAE's), and lawsuits leading to increased cost and bad quality of clinical research trial data.

2. Conducting trials: Sponsors make changes to the study protocols modifying inclusion and exclusion criteria mentioned in the study protocol after the study has started. At certain times the changes are genuine but sometimes the changes are made to widen the inclusion criteria or narrow down the exclusion criteria so that more subjects can be recruited easily.

3. Lack of trust and transparency.

4. Challenges in collaboration and communications.

Blockchain will increase and establish the trust in clinical research by the fact that tempering and manipulating the research data in blockchain is very difficult and easily traced. Self-reported data by the subjects generally lacks trust, which ultimately impacts the quality and cost of the drug trial. There is lack of trust in the way clinical research data is gathered, analyzed, and reported. Trust is further decreased because of unethical and unprofessional practices such as altering and not reporting the inclusion and exclusion criteria in a protocol to suit the interests of drug manufacturers. The timestamped block transactions can be easily traced and verified, making it less prone to manipulation and tempering. It would be worth reading the article about blockchain timestamped protocols here.

Blockchain will increase the transparency, collaboration, and communication in clinical trials. There are many partners in the clinical research ecosystem like Pharmaceutical companies(sponsors), CRO’s, study investigators (Physicians), hospitals, laboratories, insurance providers and patients, and there is a great need for all partners to collaborate and communicate effectively because human health is at stake.  The challenge is that every partner has their own technology systems which limit their ability to communicate effectively and efficiently. A lot of time and money is wasted in requesting, transferring, and communicating the information between different systems.
Blockchain brings all the trusted parties in the ecosystem to a common platform enabling them to see the clinical health records flowing through the system in real time and make timely decisions.
Not only that, Once the identity of a subject is established in the blockchain network, blockchain also addresses the issues related to subject’s dual enrollment in multiple studies at the same time saving the subject from being misused and exploitation. It is very difficult to find if a subject has enrolled in other studies. Ed Miseta, in his article, has highlighted the issue of dual enrollment in great detail here.
From sponsor’s perspective, it saves them lot of efforts wasted in subject recruitment causing higher screen failures.

Another important aspect of blockchain is that it enables a patient to play an important role as a participant. Currently, a subject is always at the receiving end of the value chain and has very limited or no access to his information. For example, in case of an adverse event, once a patient’s adverse event is notified to the physician, the patient has no idea how his case is followed up by a physician with other stakeholders. Blockchain system facilitates a patient to become an important participant in the whole ecosystem.

The inherent architecture and advantages of blockchain will make various processes and systems irrelevant and unnecessary, making the overall process of clinical research simple and cost-effective. The direct impact of this will be that it will help in bringing down the overall cost of bringing a new drug to the market, which ultimately will be passed on to the patients. More importantly, a subject would become a key participant in the clinical trial process and would be saved from misuse and exploitation.

Blockchain technology has the potential to bring disruptive changes in healthcare and clinical trials, that would make many of the current processes and businesses obsolete. It's in the best interest of the entire industry to explore the opportunities blockchain provides to remain sustainable in the longer run.