According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval. Although that figure might alarm the general public, scientists are all too very familiar with this fact. Since clinical trials do expend a great deal of time, money and intellectual capital, it is important that the public knows the reasons that such a high failure rate exists. Here we point out four reasons that most clinical trials are not successful.
- Failure to meet predetermined criteria and timelines set by the FDA: Some companies neglect one or more of the responses provided by the FDA. Companies that do fail to meet the requirement placed upon them by the FDA can jeopardize their chances of approval of later phase clinical studies or could face a complete rejection of a drug or treatment itself. This hurdle can be overcome by knowing and observing all requirements carefully.
- Not enough participants: This is basically a failure to launch. Without enough participants or the right kind of participants a clinical research project can end before it even begins. Researchers must do all they can to inform the group(s) they require that their participation is needed.
- Unproductive team: Even the most experienced project manager cannot do it all by themselves. A project manager must strive to make sure that team spirit remains high and that members remain focused so as to avoid high turnover and an unbalanced team hierarchy.
- Unskilled project manager: Of course, the opposite of the above can be true as well. A motivated and capable team can be helmed by an unskilled project manager. Inexperienced project managers tend to define unrealistic timelines and fail to involve key stakeholders in the decision-making.
Other Factors that can Cause Clinical Trials to Fail
Even the biggest and most well-known drug development companies can succumb to the following problems:
- Failure to properly interpret FDA feedback and interactions;
- Misrepresenting a drug’s safety profile by not familiarizing the FDA with the full scope of any potential adverse events before the review
- Insufficient proof of concept data
As drug companies position themselves to identify risks and make informed time- and money-saving decisions that will give them the best chance to advance to approval status, the public must understand its role in the trial process. They should know that there are many clinical trials for money and that these are critically important. So, if you are asking yourself where there are “paid clinical trials near me,” look no further than this site.