1. Protocol too complex
Trying to ‘answer’ too many questions in one single trial is seen as a regular problem leading to study failure. The surveyed experts stated that the large number of protocol amendments that follow, which are supposed to remove half of the initial endpoints, is a clear indicator of protocol over-complexity.

2. Unethical

Ethical issues pose a high risk of trial failure, severely damaging the reputation of all parties involved. In many cases, short-term gains can quickly turn into long-term losses. It is not always easy to tell when someone is being honest. Sometimes people lie or cheat on purpose, but sometimes they do it without realizing it. When a person lies on purpose, they are committing fraud.

3. Project completion vs participant eligibility issues

A new situation can arise when project management hits conflicting interests of research. On the one hand, you receive recruiting targets from your CROs but on the other hand your sites face limitations of eligibility for participants. In these instances, project management is often caught between two fires i.e. the CRO and site.

4. Quality Data

Clinical data are essential to the success of a clinical trial. Data quality is key to study closure because the conclusions drawn from the results of study completion rely entirely on these data.

5. Job Hopping

A research company surveyed their employees to understand their experiences with dysfunctional teams. Experts expressed concern about the trend of frequent job switching in today’s pharma industry. It is not hard to understand that problems will get “pre-programmed” when the team that executes a study is different from the team that designed and planned it. Also, losing a key member of the team during a trial can be like a pilot jumping out of his plane and expecting his passengers to continue flying.

Taking the above into account, it is important for a research site to ensure compliance; quality data; ethical practice; and the necessary drive to bring about the best outcomes of a trial, this forms part of our core value at MER-Clinica. Watch our company profile summary here

Info ref: Cyntegrity

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