Clinical Trials 101

Clinical trials are medical research or experiments done on human volunteers. The goal is to observe behavioral or biomedical responses on participants for medical knowledge and interventions. Clinical researchers use this methodology to find new treatments and preventive measures. The study also applies to previous clinical studies that were unable to conclusively answer a medical query. The clinical trial generates data whose outcome determines the efficacy and patient safety of the intervention method.

Clinical Trials

Preparing for Clinical Trials

Before the trial begins, it must be approved by health authorities. They review the administrative process, the biomedical composition of the intervention, the significance it will have in the medical field, and they compare the trial with similar studies. Approval does not mean the process is safe, neither does rejection insinuate insignificance of the trial. If the study receives permission to proceed, the health authorities will closely monitor its progress.

Clinical trial oversight ensures that all medical processes used are above board. In addition to health authorities, medical research facilities also have internal monitoring processes. These processes must adhere to the applicable health regulations and consider all vital data needed for the study. Temperature and physical location are some of the most critical data in any clinical study.

Clinical trials supply units of large pharma companies expect all aspects and parameters of the trial to be monitored. These measurements answer the following questions:

1) Are we successful with patient recruitment?

2) Do we have sufficient kits at the right place, time, and quality?

3) Are the results of the trial showing the expected results?

Before administering the trial, the medical research institute must get ethical approval from the health authorities. Because lives are involved,, the authorities must vet the risk-benefit factor and ascertain the study’s viability. If the trial receives approval to move forward,, the trial team initiates the study by testing a small sample group and observing the participant’s response. Gradually, researchers increase the sample size, testing the intervention’s efficacy across different stages of the medical condition in question. In essence, medical research institutes use clinical trials to test the efficacy of vaccines, nutrition supplements, medical equipment, and other medical drugs.

When monitoring clinical trials, a good system should factor in the following:

  • The breakdown of the trial administrative process

  • False alarms that might render the process insignificant

  • Tracking temperatures in containers carrying the trial kits

  • Technological infrastructure - devices like mobile phones, temperature monitors, and software

The aim of clinical trials is to demonstrate the efficacy and safety of a drug.

First, the intervention or investigational medicinal product (IMP) must be safe for use. Its chemical composition must not interfere with the participant’s normal body function.

Second, the trial must show the product’s side effects, which helps researchers come up with a way to minimize the effects.

Third, the trial should ascertain if the product works better than other drugs in the market.

Lastly, the product should help the participants feel better. After these initial requirements, the trial is ready to continue to the testing phase.

Why Real-Time Monitoring is saving your Clinical Trials

Find out how Real-Time Monitoring of Clinical Trials saves you time and money.

Learn more
Why Real-Time Monitoring is saving your Clinical Trials

New Approach of Direct-to-Patient Clinical Trials

As the world grapples with the COVID-19 pandemic, there is a need to diversify clinical trials. Physically administering clinical trial products can lead to the spread of disease, especially if the disease is infectious like COVID-19. Currently, there are no clinical trial participants in hospitals and health facilities because healthcare employees are trying to limit human interaction. Advancements in Information technology and logistics now make it possible to deliver clinical trial products to participants.

The Direct-to-Patient (DtP) model delivers the IMP to the participants’ home where they can self-administer. Research institutions employ specialized logistics companies to transport the products to the participants. This supply model moves drug administration centers from the clinical site to homes, effectively eliminating physical contact between clinical researchers and participants. As researchers adopt this new system, they expect to deliver more trial interventions and cover a larger sample area.

The DtP approach involves the following infrastructure: Logistical Networks - The firm mandated to deliver the IMP should work with a network that is able to deliver to the most remote location. Storage - The logistics partners should provide storage facilities which can accommodate the required temperatures for oral and intravenous drugs. If the trial product is a machine or equipment, the logistics company should transport it already assembled. Communication - A telehealth device aids communication between the researcher and the participant. The device can either record and transmit data instantly or serialize for further interpretation.

The DtP approach made clinical trials for COVID-19 highly successful. The trials were able to safely collect input, which medical researchers used to produce vaccines. In conjunction with participants and healthcare workers, DtP adoption was a notable achievement. There are plans underway to expand its use in the future.

Direct-to-Patient: The new trend in Clinical Trials

Find out why Direct-to-Patient is the most efficient way to distribute Clinical Trials

Learn more
Direct-to-Patient: The new trend in Clinical Trials

Kit Level Monitoring

In clinical trials, ensuring the quality of the IMP is imperative. If the product’s condition is compromised, the test may not be able to collect relevant data, and the trial is disrupted. Additionally, the product could harm the participant.

Temperature changes affect biological and chemical processes. Because most clinical trial products are by-products of biological and chemical processes, changes in temperature can shorten the product’s shelf life. By using temperature and chemical indicators in each kit, kit level monitoring provides a way to test the viability of each individually shipped IMP.

Integrity of the clinical trial process is key to making the study reliable.

Any deviation in temperature recordings may affect the final analysis. As the product is stored and distributed, the environmental conditions are likely to change. Therefore, the temperature during transit may affect the product’s viability. Supply models such as the DtP involve remote clinical trials, which changes the monitoring dynamics. Customized therapies need person-to-person interaction, complicating the trial administration, especially with the current pandemic. For both methods, time is a factor that increases the trial’s operational cost. It may also affect results, which can alter the overall outcome of the study. Kit level monitoring is ideal for monitoring IMPs through both supply chains, however long they may be.

In summary:

  • IMPs must be stored where the temperature is regulated.

  • Logistics personnel must ensure the product’s temperature is maintained during transit and storage at the depot.

  • In the DtP supply model, the participant should be aware of the effects temperature change has on the study. The trial product should come with instructions on how the participant can maintain the product’s required temperature.

  • If the study requires long term monitoring, the participant should have the appropriate storage equipment to regulate the correct temperatures and environmental conditions. A refrigerator could be an ideal place to store the IMP.

  • Use kit level monitoring throughout the entire supply chain to ensure the clinical trial incorporates temperature deviations into their analysis.

Kit Level Monitoring - Eliminating Data Collection Headaches

Data collection of Clinical Trials is giving you headaches? We have the solution for you.

Learn more
Kit Level Monitoring - Eliminating Data Collection Headaches

Applications of Clinical Trials & Site Monitoring

Drug Development

When pharmaceutical companies want to develop a new drug for a particular ailment, they must conduct clinical trials. The company first develops the lead compound through the drug discovery process. Clinical trials involve research on the chemical and biological composition of the new drug, which the drug regulatory authorities must approve.

The clinical phase involves volunteers. First, the new drug is tested on healthy people to ascertain its safety. If there are no side effects, the drug is tested on volunteers suffering from the targeted ailment. After the drug passes all the initial regulatory approvals, it goes through the final approval stages, registration, and valuation.

A good example is the development of the COVID-19 vaccine.

Medical Research

The medical field has advanced over the years with new inventions and discoveries. Medical research focuses mainly on incurable diseases and their behavioral patterns. Researchers seek to better understand available treatments of these ailments to improve the administration. The clinical trial is an integral part of the process as it collects data for research.

Researchers rely on previous studies and try to improve their processes. They develop the lead compound and use clinical trials to monitor its behaviors on participants. If the lead compound improves the outcome compared to the previous study, researchers archive the data for future reference. Most terminal disease researchers use this methodology to develop a preventive treatment, a curative drug, or a medicine that reduces its prevalence. HIV/AIDS and cancer are good examples of medical research ailments.

Medical Regulations

Emerging trends in pharmaceutical regulations require drug regulation authorities to update their guides in managing inventions and innovations constantly. Technology in the medical field improves every day. Clinical trials are avenues used to gauge advancement in the medical field and explain how these discoveries can improve the sector.

Medical researchers follow science to come up with a recommendation. Any improvement in drug development denotes progress in drug manufacturing. However, such processes may be problematic. The process could cause side effects or it could conflict with ethical beliefs. Regulation authorities employ both science and ethical standards to approve or reject a clinical trial. This prompts medical researchers to change approaches to improve its efficacy level and have the least effect on ethical and social standards in society.

Considerations When Undertaking Clinical Trials

Coming up with a new medical intervention requires in-depth scrutiny since its usage has a lot at stake. Before its application, the regulator and research institution should consider the following:

  1. Special interventions within a larger group - Research in the medical field should address special groups inside the larger drug market. As much as the intervention seeks to address a specific medical issue, special people within that larger pool need specialized intervention as well.

  2. Complex protocols - The clinical trials should have a precise sample size that will demonstrate a statistical result of the study. There should also be clear instructions for how participants use the drug (e.g., the required dosage and administration.

  3. Risks - When developing a new intervention, one should consider the observed risks from the available intervention methods. This helps control the outcome of the trials and increases the success rate.

  4. Sponsorship - The type of partners enjoined in the study could help accelerate the clinical trials.

  5. Distribution and site monitoring - The supply chain is a complex web that combines logistics, storage, temperature monitoring, and trials clinics. The clinical trials should understand the end-to-end distribution because it directly affects the viability of the project. If the intervention development and administration happen in separate regions, factors like temperature change should take center stage as it affects the quality of the intervention.

A partner like ELPRO can support Sponsors, Managers, and Supply Chain Professionals of Clinical Trials to simplify the clinical supply chain of temperature sensitive IMPs. The right temperature monitoring solution for transport and storage will not only protect patient safety but also increase and simplify patient recruitment.

Implementing Kit Level Monitoring

Implementing Kit Level Monitoring for your Clinical Trials? This is how you do it.

Learn more
Implementing Kit Level Monitoring