Clinical trials play a crucial role in drug development research for a wide array of reasons.
- They help develop new drugs/ introduce new drugs to the market.
- They help develop new clinical procedures, and
- They help develop new diagnostic tools
Clinical trials can also be an effective tool for discovering new methods of clinical research and kickstart the process of developing new drugs.
Most importantly, clinical trials provide the means to test the safety and efficacy of the new drugs on actual human subjects. Only 10% of (new) drugs that undergo clinical trials actually come out at the end of the tunnel with the stamp of approval. Meaning, the success rate of clinical trials is extremely thin.
This is probably why top tier pharmaceutical and biotechnology companies prefer hiring professional Contract Research Organizations like Novotech CRO. CRO companies enhance the success rate of your clinical trial by a substantial degree, thanks to their market-relevant experience and vast knowledge.
Apart from seeking professional guidance, the way you design your clinical trial procedure also plays a massive role.
So, here are some of the most crucial effective clinical trial design tips to help you streamline the entire procedure and enjoy the optimum result.
Implement a simple and easy clinical trial protocol
Keeping things extremely simple and straightforward is one way to ensure your clinical trial proceeds uninterrupted and butter smooth. The idea of formulating a complex protocol can be daunting for both the participants and your research team.
Of course, it is a different story if you’re going to hire professional CRO companies. But, if you’re going with an in-house research team, stick with the basics and keep the trial protocol to the bare minimum. This, of course, does not mean cutting corners on the standard trial procedure.
After all, you have to give answers to regulatory bodies like the Food and Drug Administration (FDA), or any of your local regulatory bodies.
However, keeping the protocol simple while also trying to maintain optimum efficiency can be a tricky task. More reasons why you should opt for a professional CRO company.
Set clear objectives for all the four (4) trial phases
The best way to keep things simple is to set a specific objective in every trial phase and concentrate just on achieving the same.
In phase I, the primary objective is to test the safety of your drug or device. The process will involve studying the reaction of the drug/device at various dosage levels. In addition, the effect of the drug/device on the body to determine any potential side effects is also involved in this phase.
Phase II focuses on testing the efficacy of the drug/device. Meaning this phase will help you determine the efficiency of the drug in treating the targeted disease. This phase usually involves a randomized trial, and the results are submitted to various regulatory bodies.
Phase III is a crucial trial phase. It involves blind testing and randomized trials in large numbers, usually involving up to thousand test subjects. This phase provides clear information about the safety and effectiveness of the drug. Also, once phase III is completed, a company can ask for FDA approval to release the drug into the market.
Phase IV trial, aka, post surveillance trial, is when your drug is tested and compared against other existing drugs in the market. This helps determine the genuine quality of your drug and to determine its cost-effectiveness prospect as well.
Streamline the process for all parties involved in the trial procedure
The key to success (irrespective of any procedure) is to always make sure everyone involved in it is in coherence with one another. And, that concept is the same for clinical trial as well.
Every party involved, from investors to participants play their respective key roles. Thus, it is important to keep them informed and maintain a “transparent” system.
This can be achieved by maintaining active communication pipelines, simplifying the trial protocols, or accepting their inputs and implementing that into the system.
You can also schedule timely meetings with the stakeholders, discuss your trial progress, and ask for helpful input. But, most importantly collect data to ensure maximum safety of the participants undergoing clinical trials.