Blockchain technology in Clinical Trials (Part 66)
Welcome to the 66th part of the 100-part series on Blockchain.
Behind every new drug discovery, there are an enormous number of researchers who conduct clinical trials and a vast number of people who volunteer to be a part of these clinical trials to prove the safety and efficacy of the drug. And After going through such rigorous processes and approvals, a drug gets approval from FDA.
Phases of clinical trials
There are 4 phases of every clinical trial:
Phase 1: Phase 1 clinical trials assess the safety of the drug in a small group of healthy volunteers, say 20–100.
Phase 2: Phase 2 clinical trials involve around 300 patients. These patients are evenly divided into 2 groups. One group of the population of volunteers receives an experimental drug, and the other group receives a placebo. This helps investigators, pharma companies, and FDA to understand the effectiveness of the new drug. Around one-third of the experimental drugs successfully complete both phase 1 and phase 2 trials.
Phase 3: Phase 3 clinical trials is a large-scale testing that involves several thousand patients. This phase of testing provides a more thorough understanding of the drug and its adverse side effects. Around 50% of the drugs that enter this phase 3 clinical trials are able to successfully complete it. Once the phase is completed, the pharma company can request FDA approval for marketing the drug
Phase 4: Phase 4 studies are done after the drug has been approved for consumer sale. Phase 4 clinical trial studies suggest how well the drug works when used with other treatments. Some rare side effects of the drug may only be found in large groups of people.
Phase IV studies can also result in a drug or device being taken off the market or restrictions of use being imposed on it if it is found to be ineffective and impacting the quality of life of patients.
Challenges in conducting clinical research and clinical trials
· The biggest challenge is data reproducibility. This may be due to several errors, research misconduct, or fraud that undermines the research quality. Inefficiencies in clinical trial data management is another major pain point. This leads to treatment delays, less conducive results, and sometimes even in the complete failure of a trial that could have succeeded had it been managed more efficiently.
· The interval between initial clinical testing and product approval has been estimated to an average of 8 years, with only 1 in 6 drugs ultimately obtaining approval. The average cost of successfully developing a single drug is about 2 billion USD. Many drugs do not receive approval not only because they are unsafe or ineffective, but sometimes because the information supplied is unsatisfactory to prove the efficacy of a drug.
Blockchain Technology- The Solution
Blockchain technology can have a greater impact on sharing and tracking of data. The shared distributed ledger can help to keep a record of all the data interactions that occurred during a clinical study. This will lead to an increased credibility in clinical research as, in many cases, the efforts are undermined because of several frauds. Implementation of Blockchain would be a step towards transparency. This would help to improve trust within the research communities and between research institutions and patients.
(i) First and foremost, all the events in clinical research can be tracked through Blockchain. This will eliminate data falsification or data beautification cases. The Blockchain will record and time stamp all the information like researchers involved in the study, designed protocols, sample size, way of administering the drug to patients, way of data collection, and data analysis. And in the case at a later phase during the study, the researcher wants to change the sample size or wants to revise the protocol, all this information will be fully documented and easily accessible on the Blockchain. Each and every transaction related to clinical research will be time-stamped on the Blockchain. It will also enable the researchers to manage their data more efficiently.
(ii) Before clinical trials begin, it is mandatory to take the consent of a patient. The research protocols should also be in accordance with the guidelines of the regulatory bodies. According to FDA, around 10% of clinical research trials have issues related to consent collection from patients, failure to obtain written consent, unapproved forms, expired consent, consent form without date, and failure to get re-consent to a revised protocol.
Even document frauds are also reported, for example, backdating the consent forms. Taking consent is crucial for the safety of patients. According to a report, in 2016, an analgesic killed a patient. The investigation proved that re-consent was not sought from the patient before administering the drug to him when the major neurological side effects of the drug were reported in some patients. Even the re-consent has to be taken from a patient if the protocol has been redesigned.
In a permissioned Blockchain-based system, all the information about the drugs, designed protocols, revised protocols, as well as consent and re-consent forms will be stored on the Blockchain. Patients registered for clinical trials will also be nodes in this system and will be given permission to access all the information related to protocols and consent forms. Besides, this will ensure patients’ safety and the protection of their rights. A smart contract will be executed whenever any change in the protocol occurs, and a consent form will be sent to the patient for his re-consent. After getting the re-consent, the patient will get automatically enrolled for the clinical trial. Now the proof of the existence of consent and re-consent will be available to all the stakeholders, including investors, pharmaceutical companies, research organizations, and regulatory bodies involved in clinical trials.
(iii) Blockchain can make it possible to track all patient-doctor encounters. Till date, all the clinical trial results are not reported, but with the implementation of Blockchain, any such data will be recorded on the shared ledger and can also be reviewed by other researchers.
(iv) Recruiting people for clinical trials is a major task which accounts for nearly one-third of the total timeline of a clinical trial. The patient data is largely secured in siloed individual databases with limited interoperability and transferability. This makes the recruitment of patients very difficult. Pharma companies have to reach out to physician offices individually and attempt to recruit patients. It is also very difficult to find a sufficient no of patients. Many clinical trials get delayed because of insufficient no of patients.
(v) Patients who may be interested in going for clinical trials are largely unaware of such opportunities. According to a study by The Journal of Community Oncology, only 16% of cancer patients knew that clinical trials were an option for them at the time they were considering treatment options. It means that around 85% of the patients had no idea that they can explore the treatment options offered by these clinical trials. This dichotomy results in financial losses for the clinical trial administrators, and missed opportunities for patients to try these new therapies.
Blockchain-based distributed ledgers can address this issue of patient recruitment.
Patients who are willing to go for clinical trials will be listed on a distributed database, and drug companies can directly reach them and recruit them for the clinical trials. Thus, skipping the hassle of visiting physicians personally. They can reach large numbers of potential participants and can get enough information about them to contact and recruit them. This can speed up the recruitment time.
(vi) The distributed ledger technology can be a proactive way for drug companies to prove that they comply with all legal and human rights issues. Because the complete time-stamped procedure of performing clinical trials will be available on the Blockchain. The respective organizations can easily verify that no unethical or illegal means are being used by pharma companies for these trials, thus bringing trust and transparency to the system.
Scalability concerns
(i) Storing vast amounts of clinical trial data, including consent forms, protocols, and information about the drug, patients, researchers, hospitals, patient-doctor interaction, FDA approvals, etc., on Blockchain is expensive and energy-draining. Thus, distributed file storage IPFS can provide low-cost off-chain decentralized storage to store data. A unique hash is generated for every uploaded file on the IPFS server, which is then stored on the Blockchain and accessed through the smart contract. Any change in the uploaded file would change its hash. IPFS has been explained in detail in Part 18.
(ii) To make the Blockchain scalable for its use in clinical trials, layer 1 (discussed in Part 15) and layer 2 (discussed in Part 16) scaling solutions will be required to be implemented.
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