Post-pre-clinical approval processes, every drug or treatment undergoes a series of clinical trials that determine its higher capabilities over existing medications and other procedures in terms of safety, effectiveness, health benefits, cost, etc. Each of the trials is outlined with specific protocols that establish the study’s aims, participant and test characteristics, scientific approach, outcome measures, and procedures for statistical evaluation of data acquired. After the pre-clinical research stage, mostly involving animal trials and ADMET simulations, the scientists apply for regulatory approval from institutions such as the FDA and other governing bodies to proceed with the enrollment of volunteers for testing. Pharmaceutical companies and research organizations advertise to the public or target groups candidates via hospitals, clinical trial registries, pharmacies, and dedicated clinical trial recruitment websites with detailed criteria.
Before the formal enrollment process, each of the candidates would be required to undergo a screening process that tests them for all the inclusion and exclusion criteria such as age, gender, previous health history, underlying genetic conditions, stage of that particular disease, etc. This is followed by a formal medical and legal consultation of the shortlisted candidates where they are informed of the purpose of the trial, treatment procedures, candidate’s responsibilities, potential risks involved at each of the stages, compensation in case of any trial-related injury, anticipated expenses, prorated remuneration, duration and the number of participants involved in the trials; bodies granted access to the candidate’s data and legal protection. The candidates complying to all of the above conditions are then asked to sign an informed consent form, usually ironclad contracts that indicate voluntary participation, nonpersuasive language, that protect both bodies from liabilities.
Clinical trials occur in various phases during which different aspects of the drug and its side effects are studied by varying dosages and other parameters. Phase 0 is usually performed on people fewer than 15 in the number given minimal dosages. If the drug acts differently than expected, the research team moves back to pre-clinical research and further modify it. This is followed by phase 1, which is longer and involves 20 to 80 participants with no underlying health conditions in which the dosage is subsequently increased to a point until side effects become visible. This gives the researchers an excellent opportunity to witness how the bodies react to the medication and accurate estimates of safe dosage. According to FDA, 70% of drugs entering clinical trials move on to phase 2 in which the drug is administered at the recorded dosage that was deemed safe in the earlier phase to hundreds of participants who already have the condition the drug is supposed to treat.
33% of all the drugs in clinical trials move on to phase 3, where the participants’ profiles and dosages are similar to the ones in phase 2 but have a lot more participants (around 3000). They follow a process called randomization, a double-blind process where neither the investigator nor the participant knows if the drug administered to that particular candidate is the one under trial or an already existing medication or placebos in case of no existing medicines. Additionally, phase 3 trials are required to have an independent data-safety-monitoring committee that reviews study outcomes and side effects during the trial to assure participants that the study remains appropriate for their medical condition. Phases 2 and 3 are quite long and take up to several years to be completed, which helps reveal rare and long-term side effects amongst participants. And if the research teams deem the medication safe and effective throughout all these phases, the FDA would approve the medication (around 25-30% of all the drugs entering clinical trials are approved). The clinical trial finally ends with phase 4, also known as Post Marketing Surveillance Trials, where thousands of people use the FDA approved drug, which provides the researchers with insights about long-term safety, cost-effectiveness, and health benefits.
Clinical trials are supported and funded by the government, biotechnology companies, pharmaceutical giants, charitable organizations, and many more private sponsors from various backgrounds. Each stakeholder contributes to the studies with varied sets of tools such as money, personnel, academic expertise, informatics, infrastructure, and so on. It causes significant delays in every step to bring these resources together for each trial. Subtl can act as a unified system where all the information can be securely shared/uploaded by each of the departments without compromising on the knowledge gap. Also, as trials become more geographically diverse, hiring and training experienced clinical researchers to work together has become very tricky and costly. Subtl produces accurate and straightforward responses from the information provided to queries raised by users with personalized access, thereby improving the teams’ productivity. It can also eliminate the hassles of recruitment and retention of the participants by providing them with all the resources required to facilitate their comfort. The recruitment process undergoes multiple amendments and iterations due to strictly demanded compliance with scientific, regulatory protocols enforced by the ethics board and other review committees, and technology transfer. Subtl can help reduce the time taken between protocol approval to trial activation to a vast extent by eliminating the above redundancies and freeing up funds to be used in other essential areas.
Furthermore, case report forms that contain data of each participant at a particular stage of clinical trials are variably complex and are linked to high costs of trials, i.e., monitoring costs as they involve a considerable number of data points and lack standardization. Once the clinical trial sites are activated, it is imperative to capture accurate data, resolve issues swiftly, track compliance with protocols, and constantly monitor KPIs and endpoint data. Subtl can help erase poor understanding of collection protocol, errors in data analysis, and unsatisfactory data quality by simplifying and filtering out requested parameters at each stage for the researchers to study and engage in compliant practices throughout the research enterprise. Moreover, it can bolster the standardization and accountability of research bodies during safety reporting and causality assessments by enabling quick and secure disposal of confidential information to regulatory boards. Overall, clinical trials are highly synergistic in nature and need to be performed in the most systematized conditions at every step while keeping the costs to a minimum, all of which can be catalyzed by Subtl while safeguarding the trial’s stakeholders’ interests.