Top 4 challenges in clinical trials you should be aware of!
With Covid-19 vaccine development we heard a lot about clinical trials and we were eagerly tracking development of the much awaited vaccine. Fortunately we developed and made it available to the public in a record amount of time. It is very important for everyone to understand what challenges it faces in research, development and trials of vaccines OR drug development.
Clinical trials are indispensable in drug development. For development of a new drug, the drug undergoes a series of tests and studies. These studies are crucial to ensure safety and efficacy of new treatments which help the individuals who need a cure or treatment for their conditions.
New drugs and therapies can remarkably improve the results for patients, after making it through four phases of clinical trials. The four phases of clinical trials assess benefits and risks. During these phases, trials face various challenges but since trials are essential to get a drug to the market, tackling these challenges is crucial.
Four biggest challenges faced today in clinical trials are:
Subject recruitment and retention
The biggest challenge starts at the beginning of trials, it is subject recruitment. It is one of the main reasons for failure of clinical trials. The studies are either halted or terminated due to inadequate number of patient recruitment. Most important reason for this is precise requirements of the study protocol. Other reasons include lack of awareness about clinical trials in patients and sociocultural issues related to trial participation.
The recommended way is to target the patient population by providing community outreach programs, educating patients about benefits of clinical trials, and providing all treatment options to patients.
Factors affecting retention are complexity of protocol, experiencing serious adverse events, subjects fear for study procedures, financial burden of travel to site, and side effects due to investigational drugs.
Retention of subjects can be kept by providing materials that are easy to understand, supportive staff, helping patients to minimize stress during the study.
Inability to demonstrate efficacy
You might have heard in the news lately about the efficacy of different Covid-19 vaccines and people’s preference to vaccines based on efficacy rate. To demonstrate efficacy to the public does not come easy.
The predominant reason for trial failure is inability to demonstrate efficacy. This failure may occur due to inadequate subject recruitment, improper study design, inappropriate endpoints, or underpowered clinical trials which cannot reject the null hypothesis.
Improving the efficacy and effectiveness of clinical trials can be obtained by using adaptive study protocol design consisting of patient centered and amiable procedures. And it is necessary at every phase of drug development to have safety and efficacy be a priority to gain confidence of the public who will be eventually recipients of the drug.
The professional patient problem
The term “Professional patient” indicates mainly three types of patients in clinical trials. First, those who falsify a condition in order to get admitted to a trial. They make it seem like they are participating throughout the trial and get compensation at the end of the trial.
Second, there are patients who do have the condition that the trial is researching, but they do not actually want to be treated for it and will fake the results of treatment.
Finally, there are patients that do have a condition and actually participate in the trial, but may be participating in more than one trial at same time. These patients often are those who cannot afford traditional medical treatment and participate in as many clinical trials as they can to obtain both treatment and compensation.
All three types of professional patients deceive the trial data and threaten its ethics. However, replacing compensation rewards with compelling copy, conspicuous trial information, and targeting particular and efficient groups can help trials by attracting only patients who can help to get a drug to the market.
Virtual Clinical Trials
A virtual trial, also known as remote or decentralized trial, is a digitally empowered clinical trial process. Along with the benefit of retention and increased engagement of subjects as patients can participate in the study from their comfort place, various challenges occur in the virtual process.
Major challenges include data privacy, data management, obtaining relevant data of technological devices necessary to monitor and reduce risks associated, performing study protocol requirements like biopsies or other medical tests and trouble in working with diseases of extreme severity. Another challenge is lack of personal dealing of investigators and site team coordinators with patients can affect the standard of treatment of care.
These challenges can be defeated by using advanced applications rather than traditional methods and developing user friendly and alluring technology to reduce participation drop out. Also utilization of online social engagement platforms can help target a more accurate population.
Clinical trials are vital for developing new treatments for diseases and bringing a product to the market. Drug development processes give understanding of the interaction of drugs and humans to researchers to create safe and effective drugs possible. But the challenges related with conducting a clinical trial must be resolved in order to accelerate the drug development process and focus on patient-centered care.
