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5 Common Challenges In Clinical Trials That Involve Patients

Clinical trials are medical research studies that assess a patient’s health and behavioral changes subject to new drugs or surgical procedures. You can group them into two broad categories, which are behavioral and interventional trials. While the former aims to discover what happens to patients in different situations, the latter concentrates on a specific treatment.

The trial results are used in concluding how successful the drug or procedure is for a patient. Also, it helps analyze the side effects. It’s essential to carry out clinical trials given the current rapid boom of new diseases. Clinical trials help physicians know more about the disease, symptoms, and preventive measures.

Typical Phases

Over time, the standard procedures for carrying out clinical trials have evolved. Presently, the four primary stages of clinical trials are:

  • Phase 1: Tests and experimental treatment are administered to healthy groups of people to observe any side effects. This phase also seeks to identify the correct dosage.
  • Phase 2: The number of people in this phase increases. The main aim of this phase is to test the procedure’s effectiveness. It may last several years as observations are continually made, resulting in preliminary data used in conclusions.
  • Phase 3: In this phase, the dosages may vary and include other drugs in their treatment procedures. If the trial result shows favorable rates, the drug is approved for treatment.
  • Phase 4: The drug is closely monitored as many people take it. This is because the side effects of a treatment procedure may take time before showing up.

Why People Participate In Clinical Trials 

People take part in clinical trials because of the following reasons:

  • If someone has tried several other treatments that aren’t working, participating in a clinical trial could help physicians learn something new about their condition.
  • It gives access to treatments that aren’t yet popular with the public.
  • One gets better health care from leading health centers.
  • It helps others by contributing to research.
  • Participating in a clinical trial is one way of actively taking control of one’s health.

The Challenges

Despite the evident advantages of clinical trials, they’re not always a walk in the park. Extensive research must be done, and several preventive measures should be implemented to ensure safety. It requires maximum attention since the lives of people are at risk. Below are common challenges in clinical trials that involve patients:

  • Complexity Of Trials

Clinical trials are carried out under strategic and sophisticated procedures. Sometimes, physicians have a tough time analyzing data within the required time frames. Remember, an error in carrying out the operations could lead to the death of scores of patients. Again, diseases and symptoms evolve as time goes on. Thus, it may be considerably complex to handle the trials and assessments. There’s also the pressure to design studies with the correct treatment procedures. Previously, clinical trials have relied on spreadsheets to record information and analyze data to conclude.

However, that’s changing with the development of clinical software, which can relay critical data for clinical procedures. Software use helps ease the complexity of trials, making data analysis faster and simpler for physicians.

For further insight into this, Formedix shows you how clinical trial software can be used to optimize clinical trials. With such software, you’re guaranteed to build studies quickly and store data properly for easy retrieval. The repository has impact analysis features to manage the research in a manner that facilitates submission to the U.S. Food and Drug Administration for approval.

  • Governance And Oversight

There are very many stakeholders involved in carrying out a study to completion. These include partners sponsoring the trials, Contract Research Organizations (CROs), and study sites. All these vendors don’t make it any easier for a clinical trial to run seamlessly. Having all of them agree to allow you to conduct the clinical trials may take quite some time. This may discourage the physicians when they think of how many signatures they need to get a clinical trial running. Additionally, such processes increase the overall duration of a clinical trial.

  • Recruitment Of Participants

Taking part in clinical trials solely depends on free will for both physicians and patients. You need enough participants to get the go-ahead in clinical trials. Remember, the tests are carried out in phases; the more participants, the better the results. It may take more time than projected to get a sample size to start the trials.

Again, there are qualifications for one to participate in the trial. Not everyone willing to take part qualifies for the test. Some patients may have underlying conditions that disqualify them from participating in your research. For this reason, many trials lack enough participants and hence get canceled. Due to the low number of participants, clinical trials aren’t successful in most instances.

  • Rules And Regulations

Keeping up with the terms and conditions of medical regulations is also a challenge when trying to do clinical trials. Before pharma companies can initiate the trials, they must comply with all the requirements.

Although the requirements vary with countries and regions, the challenge cuts across. For all medical tests, you must conduct a pilot trial on animals. The trial has to work or have negligible effects on the animals. You must also have permits and the proper documentation.

These, among other regulations, make it hard to conduct research. You end up with hefty budgets to carry out a single trial.

  • High Cost Of Conducting Clinical Trials

Compared to other forms of trials, such as academic ones, clinical trials cost a lot of money. It’d help if you had advanced technology, qualified personnel, and high-quality equipment to run your tests smoothly. According to research, a clinical trial could use up to 2 billion USD before completion. This makes it harder for smaller pharma companies to go for clinical trials. On the other hand, some participants require compensation for taking your tests, increasing the overall cost.


Clinical trials are essential for medical studies but may sometimes crumble or fail before they start. There are very many factors that make trials challenging, some of which are outlined above. If you’re planning to carry out a clinical trial, knowing the potential challenges helps you prepare adequately. With a proper strategy, you can overcome most of the challenges. They shouldn’t deter you from doing your trials because they’re essential in finding treatments for new diseases.


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