A Clinical Research Sites plays an important part in conducting a clinical trial. It is a hospital or a clinic where patients are recruited, screened and administered the medicine and observed. The clinical trials sponsors continuously look out for clinical sites that can collaborate with them to conduct the trials. The relationships established are long-term and strategic. The competencies developed by the clinical sites, like expertise in a particular therapeutic area or experience in recruiting patients for large phase-3 trials, make them attractive to sponsors and are compensated accordingly. Bottom-line is that it’s their bread and butter to many of them, and hence critical to their survival.

The COVID-19 pandemic suddenly forced the clinical industry to stop clinical operations at clinical sites. Patients were advised to not visit the clinics or hospitals unless it is something absolutely necessary. The clinical sites stopped operations impacting the ongoing as well as new clinical trials. Even after 8 months now from when the COVID-19 started, the situation has not changed. Many sponsors and CRO’s sensed that early and started thinking through ways to minimize the disruptions. 

Sponsors are looking for ways to minimize the patient visit to clinics. Under normal conditions, the patients were required to visit the clinic or site for regular consultation, checkup, follow up , lab sample drop, measurements etc. Some of these site visits, for follow up and consultations, can simply be completed through virtual mediums like telephone, audio/video chat through the Internet. Some of them are not really needed.

Sponsors and CROs are now revisiting or redesigning their study protocols to eliminate unnecessary procedures and visits. They are now making necessary changes to their IT infrastructure to adopt methods used in telemedicine to consult and communicate with the patients remotely and securely.

Site visits related to lab work such as blood work or urine sample collection are being conducted at partner network laboratories near the patients home. The Sponsors and CROs are partnering with large laboratories to provide services to patients participating in clinical trials further eliminating the need for patients to visit clinical sites. They are also partnering with large pharmacies and courier delivery services to deliver the study drug to patients’ homes. 

In a fully virtualized trial, the sponsor or CRO will conduct the trial through the supply chain established through the network of partners providing specialized services and monitor it through a central call center. The role clinical sites are playing in conducting clinical trials today, will reduce in the future. This would be similar to what large online retailers did to the small brick and mortar stores business model.

Not all clinical trials can be conducted virtually but the industry is continuously moving in that direction with a greater pace now, especially after COVID-19. The clinical sites relying heavily on clinical trials for their survival need to comprehend the situation early and start thinking about transforming themselves to stay relevant in the industry.

Disclaimer: The views expressed are the author’s personal views and do not represent the opinion or endorsement of any entity whatsoever with which the author has been, is now or will be affiliated. The author does not accept any responsibility or liability for any direct, indirect, or consequential loss or damage resulting from any such irregularity, inaccuracy, or use of the information.

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Detroit, Michigan / July 20, 2020 – Oakbloc Technologies, a technology solutions, service, and platform provider to the clinical trial and healthcare industry, today announces the launch of the first-ever free, interactive and user-friendly Clinical Trial Site Finder app developed using open-source. The solution is designed to help patients, physicians, healthcare providers, clinical researchers, governments and non-profit organizations use data to increase patient participation in COVID-19 and other chronic and rare disease clinical trials and spread awareness.

Insufficient recruitment is still one of the primary reasons for many study failures. Very low levels of awareness and misconceptions about clinical trials has been the primary factor for low participation. Searching for a movie theater nearby is much interactive and easier than finding a clinical site. Poor UI and search features makes searching for clinical trials difficult and non-intuitive. Oakbloc felt a need to provide an interactive app with an intuitive UI to search for clinical trials in any part of the world on a map to enhance user experience. The data obtained from clinicaltrials.gov is presented in a way that makes it interesting and easy for the user to search for a clinical site.

Oakbloc Technologies strongly believes that Kalehdoo Clinical Site Finder App will help increase the awareness and participation in clinical trials helping researchers develop new drugs and vaccines early to help mankind. Oakbloc technologies seek support from physicians, governments, non-profit organizations and special interest groups to spread awareness about the benefits of clinical trials to patients.

Oakbloc released a 90 seconds video on youtube demonstrating accessing and using the Kalehdoo Site Finder App.

About Oakbloc Technologies

Helping the Pharmaceutical industry adopt new technologies to improve healthcare, drug research, and supply chain. The clinical trials industry is moving towards making clinical trials more patient-centric through the adoption of virtual trials and telehealth technologies.

Oakbloc enables and assists Clinical Trial Sponsors, CROs, Physicians, Researchers, Special Interest Organizations, etc. in the adoption of the emerging technologies: Big Data Analytics, AI/ML, Blockchain, Smart Device, and IOT in a variety of ways and combinations that will significantly advance the practice of clinical trials and remove or reduce some of the major challenges facing the industry. We are essentially technology solutions, service, and platform providers to the clinical trial and health care industries.

Oakbloc has developed technological accelerators, solutions, and platforms to accelerate the adoption of virtual clinical trial and telehealth by industry.

Contact

Email: contact@oakbloc.com
Facebook: https://www.facebook.com/oakbloc
StudyFinder page: https://www.oakbloc.com/sitefinder.html
Study Finder App: https://kalehdoo.shinyapps.io/app02

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The clinical research industry was adopting the technology in a slow and incremental fashion while other industries adopted new technologies that brought transformational changes in those industries. Even today, the clinical data recordkeeping is largely paper-based or EDC (Electronic Data Capture) is just a digital form of a paper. Those who use EDC systems believe themselves to be technology adopters and innovative. The patient data is still entered manually into the systems and the data that is not entered is considered to be non-existent. The data collection is still a foreign concept. A patient is simply a subject in the whole clinical trial process.

The pandemic has exposed critical gaps and vulnerabilities in the healthcare and clinical research industry and has forced the industry to leverage technologies used in telehealth and telemedicine to minimize disruptions in the clinical trial operations. The advocates of Blockchain technology suggests many use case of Blockchain technology in clinical trials. However, it has failed to generate enough interest in the clinical trials industry.

Blockchain has definitely been recognized as a potentially disruptive technology that can solve the problem of trust and transparency bringing transformational changes in healthcare and clinical trials. The experts who understand blockchain technology and clinical trials suggest that blockchain can help in solving many industry pain points related to informed consent, record keeping, payments, and recruitment. Despite all of these benefits, blockchain technology has been neglected and did not find its place in the priority list of the stakeholders.

Blockchain may not be a magic pill that can solve all the problems and pain points. Blockchain may have built-in accountability but a lot of it depends upon how the security is designed, like any other system. Blockchain may have its own limitations and challenges but it has enormous benefits that increase the trust and transparency in clinical trial data. It turns patients from health consumers to health producers, and give them the ownership of their data. The regulatory agencies benefit greatly from the trust and transparency that makes the underlying data trustworthy. But the important question here is, how do sponsors benefit from blockchain?

A sponsor decides what technologies they need to invest in. Let’s think from a sponsors perspective. What incentive do they have to invest in Blockchain? Their basic aim is to conduct a clinical trial and obtain data to gain approval from the investigative new drug. If they can conduct a trial without making any extra investment in blockchain then there needs to be some other incentive to adopt new technology. Simply because Blockchain is a disruptive technology, it doesn’t offer any immediate benefits to sponsors. Blockchain is a decentralized structure of the backend database structure. The frontend user interface of a blockchain application may not look any different from a non-blockchain application. A sponsor works with many CROs and clinical sites who have their own clinical trial management systems and other peripheral systems which makes it a web of complex systems sharing information with each other. It would be a difficult adventure to bring in new systems that were not tried and tested in similar settings.

Everyone likes to have freedom but it’s another thing whether people exercise that freedom or not. That’s human nature and the executive decision-makers in the life-science industry are humans too. Blockchain records are immutable and timestamped, and any changes made to the data records are traceable. There is no doubt that sponsors make every effort to safeguard the trustworthiness of clinical data and do not indulge in any kind of malpractices, but the possibilities of foul play by a few sponsors with malicious intentions cannot be completely ruled out. There are possibilities of tempering with the data. Psychologically, it is quite possible that sponsors get a feeling of insecurity driven by the fear that everyone is watching now. To some, it may come as a threat to their freedom of altering things for their interests best known to them. Transparency is the foundation of trust, and it is in the interest of the entire industry to be more transparent. Blockchain can help sponsors achieve that goal. Greater transparency opens the doors to more business opportunities. The improvement in brand equity is substantial and long term, and so sponsors have every reason to become more transparent without any fear or doubt.

It may be difficult for Blockchain to find clinical trial sponsors who willingly want to adopt the technology simply because of its features and benefits. The industry would need to take sponsors in confidence and work with them to incentivize the adoption. Regulatory bodies like the FDA can enforce the implementation of blockchain but it may be impractical and counterproductive. However, they can develop and promote such solutions and let the industry choose if they want to adopt. Recently, the FDA has created an open-source app called MyStudies App to be used by sponsors to obtain informed consent remotely during coronavirus pandemic. It is difficult to say how many sponsors would have used that app but it makes sense from sponsors’ perspective to benefit from it instead of investing to develop their own solution. FDA’s branding will give them another reason to trust the technology if they develop another version with a blockchain option. Otherwise, the responsibility then lies on the shoulders of CROs and technology companies to introduce adaptors, accelerators, and plug-ins for specific modules that integrate seamlessly with existing systems. Developing blockchain-based clinical trial management systems may be a huge effort to have a very low chance of successful adoption. There are a few startup companies like Bloqcube who have accepted this challenge to develop blockchain-based clinical trial management systems.

There is an opportunity for small blockchain-based tech startups to develop such adaptors for very specific modules. For example, developing an adaptor for a blockchain-based module to obtain informed consent from the patients. The 21st century is an era of open-source technologies. Companies do not need to re-invent the wheel from scratch. The open-source MyStudies app can be modified to reuse its frontend and have a blockchain backend database. The real challenge may not be in developing such an application, but the implementation of it. Finding the right sponsors and CROs who are genuinely interested to collaborate with tech companies, and willing to invest in finetuning the app by filling the gaps for a smooth adoption.

Blockchain platform vendors such as IBM and Oracle will play a bigger role in blockchain adoption. Both of these big vendors have highlighted possible use cases in the clinical trials. There are many other vendors, small and big, that offer blockchain platforms as a service. Many have programs for startups who want to build their applications. Since these big vendors already have business relationships with sponsors, they are conveniently placed at a sweet spot form where they can easily engage and collaborate with sponsors.

The blockchain adoption by the clinical trials industry is not going to be an easy hill to climb but a coordinated effort by other stakeholders working hand in hand with sponsors in that direction can make things easier. Continuous efforts to educate sponsors about the benefits and engage them in discussions can further provide that extra horsepower required for making the clinical trials industry narrow down the gap with other industries. This is in the larger interest of the whole healthcare and life-sciences community, and every small effort in that direction makes a big difference because the stakes are high.

Disclaimer: The views expressed are the author’s personal views and do not represent the opinion or endorsement of any entity whatsoever with which the author has been, is now or will be affiliated. The author does not accept any responsibility or liability for any direct, indirect, or consequential loss or damage resulting from any such irregularity, inaccuracy, or use of the information.

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The home health services have been used successfully in telehealth for quite some time now. In COVID-19 like situations when patients cannot travel to clinical sites, one option for sponsors is to reach the patients at their home. The study participants make a visit to the clinical study site mainly for medication, lab work, consultation, and observations. If the sponsors can perform all those functions at the patient’s home, then the affected clinical trials can be restarted. Therefore, there is an increasing demand for such home services.

From a patient’s perspective, home health services would be convenient saving time and money. However, from the sponsor’s perspective, it brings a lot of economic as well as operational overhead and challenges. Sponsors are required to make new arrangements, partnerships, and contracts to cater to home health services to their patients. In a way, it is almost like setting up a new business model. In most of the cases, providing home services in a clinical trial setting may not be a sustainable business model. It would make sense if sponsors use home services to save the paused studies but they need to carefully avoid falling for the sunk cost fallacy trap.

From a sponsor’s perspective, clinical operations continuity is highly critical for financial cash flow reasons. A few paused studies for a couple of months would be enough to throw companies into a cash crunch, especially the ones that have a short pipeline of genuinely promising drugs. During times when every other business is exercising great constraints in cash spending, making investments in a business model that is unsustainable may prove to be a misadventure. The higher rates of unsuccessful clinical trials make decision making for executives more challenging, except for the ones who heavily rely on their gut feelings.

The home services may not be economical for large studies when there are thousands of patients and hundreds of sites spread across different countries and cities. Imagine the logistics required if we have to provide home services to such a large diverse population. Coordinating and monitoring such an initiative requires a lot of expertise and infrastructure. The sponsors would have to equip clinical sites and train the resources to provide the home services. If there are requirements to send the nurse to administer the medicine or collect samples, there would be a need for extra manpower to serve the patients in a timely fashion. For example, if we consider that a nurse can attend 5-7 patient visits in a day then the site with 100 patients would need a minimum of 3-4 dedicated nurses to complete the job in a week’s time. Considering that clinical sites participate in multiple clinical trials, maintaining a desiccated staff for every clinical trial would be impractical. Things can get complex when the patient demands more time from the staff due to their personal problems at home.

To minimize the operational costs, it makes sense for sponsors to contract with pharmacies and home health services who can provide such services on a per-visit basis. A dedicated central call center can coordinate the requests, and also help resolve queries from patients. However, such an arrangement will potentially take away much of the responsibilities from clinical sites and put it in the hands of sponsors.

Dealing with home service providers will have their own challenges. Pharmacies and laboratories mostly provide services to healthcare patients. In many cases, the healthcare home visit is covered by medical insurance and hence the services are costly. The staff is also trained for healthcare needs, and have their own priorities. Striking a win-win and cost-effective contract with healthcare home services may not be that easy. There would be a greater need to train the staff from a clinical trial perspective.

Companies providing home visit services specialized for clinical trials can fill that gap helping sponsors provide customized and reliable home services in a cost-effective way. Such survival provides can work with clinical sites on a need basis. The biggest advantage of this is that sponsors do not need to make an investment in setting up the entire supply chain. Also, sponsors get more flexibility and freedom to strike contracts with smaller specialized companies. Since the services providers are specialized, the training requirements would be low. Flexibility allows starting the study quickly.

Simply waiting for the COVID-19 to improve to resume the clinical trials may not be an option for the sponsors. Depending upon what strategy they choose, the clinical trials industry will transform itself making many existing processes and practices obsolete. Also, it will generate a demand for new business opportunities. It would be interesting to see how much of the impact on the clinical trials industry will remain permanent after the COVID-19 situation improves.

Disclaimer: The views expressed are the author’s personal views and do not represent the opinion or endorsement of any entity whatsoever with which the author has been, is now, or will be affiliated. The author does not accept any responsibility or liability for any direct, indirect, or consequential loss or damage resulting from any such irregularity, inaccuracy, or use of the information.

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