4 Common Problems In Clinical Trial Designs

Clinical trials are crucial aspects of drug and therapy development and research. A clinical trial encompasses various stages, requiring the collaborative effort of scientists, healthcare professionals, patients, and other private and government sectors. They work together to ensure the potency, effectiveness, and safety of a new vaccine, pill, intravenous solution, treatment procedure, and others.  

Attaining a successful clinical trial can be challenging because of the rapid increase of new diseases, the discovery of more complications, external pressure, and others. Moreover, the rising clinical trial design problems add to the burden, causing huge delays in launching a new medication or treatment on the market.  

Contract research organizations (CROs) and other agencies designing and initiating clinical trials face common problems that this article will discuss in detail below.   

1. Lack Of Transparency  

Pharmaceutical companies and healthcare agencies designing and conducting clinical trials often face issues in data transparency. Lack of transparency usually stems from still adapting traditional clinical trial practices. 

Researchers use spreadsheets in a traditional setting to record and handle different aspects of a clinical trial. However, the problem in using spreadsheets is the high risk of human errors and erroneous data validation, leading to transparency issues. There's also a risk of compromising compliance, efficiency, and quality patient care. 

The CROs and other concerned research agencies must invest in clinical trial software to promote transparency for more accurate data gathering, validation, monitoring, and reporting. Clinical trial tech solutions may include an electronic data capture system or EDC, clinical trial management systems or CTMS, and integrated clinical study automation software. 

2. Diversity Issues  

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Clinical trial designs must consider diversity or the differences in people's age, gender, race, religion, and other demographic, cultural, and lifestyle factors.  

Testing a newly invented medication or treatment on diverse subjects is crucial to ensure their effectiveness and safety to the overall population. Researchers can quickly determine adverse reactions and other negative effects. In that way, scientists can adjust dosages or modify or replace active ingredients to avoid side effects, overdosage, and other related problems.  

However, there's still a significant problem in diversity when it comes to designing clinical trials. Recruitment teams have a hard time encouraging prospects to participate in clinical studies.  

The value of diversity in clinical trial design has been significantly shown in addressing the emerging health crises that the world faces nowadays. A good example of diversity in clinical trials is the recent development and testing of the COVID-19 vaccine; wherein there was a need to administer it to people of different ages, genders, ethnicities, races, and health conditions.  

Massive information dissemination or patient education is a must to resolve this problem. It involves the collaborative effort of the private and government sectors, especially during a pandemic or crisis.   

3. Outdated Patient Criteria  

Structural barriers, such as outdated patient criteria, are one of the causes of low participation rates in clinical studies.  

Physicians are the primary ambassadors of patient education. They also have a valuable role in guiding patients across all clinical trial stages and ensuring that study designs have updated criteria aligned with modern demographics.  

Eligibility criteria define the patient demographics and characteristics under investigation. The CROs and related agencies must tailor these criteria for a specific group or target population to assess the effectiveness and adverse effects of a new drug or therapy. Therefore, identifying and updating exclusion and inclusion criteria are critical in a clinical trial. 

4. Management Of Ethical Issues  

Clinical trial designs face enormous ethical issues, especially involving mass animal and human subjects. Testing new drugs or therapies may involve significant risks of overdosage, adverse reactions, and sudden death. For this reason, ethical deliberation is a critical aspect of designing a clinical study.  

Ethical considerations are a must-tackle topic before a clinical trial design. The significant people involved in this phase include scientists, lawyers, academes, religious leaders, and government authorities. In addition, public consultation and information dissemination are crucial to let all parties understand a clinical study's purpose, workflow, and possible effects.  

All agencies, such as the Food and Drug Administration, must meet and set regulations for clinical trials according to acceptable standards and laws. This step is imperative whenever new findings, changes, technologies, and innovations in clinical trials emerge for constant monitoring and safety.  

Conclusion 

Continuous testing and enhancement of clinical trial designs can help resolve related problems and provide patients with high-quality drugs and therapies. Every clinical study is a learning experience. Good collaboration, patience, and hard work of CROs, the government, physicians, and other healthcare workers are essential to address the common clinical study problems. Moreover, investing in technologies can help make every clinical trial more seamless and positive.