After lots of research, you now have a lead device or drug that an organization can use to start clinical trials with Veristat. The tight design for your trial will ensure that you have a successful outcome thus delivering a drug to the market. Here are five very important steps you should keep in mind as you a successful trial design.
Keep it simple
Consider answering only one question or formulating only one hypothesis to help avoid protocol complexity. Create the virtual clinical trials project starting from the bigger picture down to the smaller parts. As such, meeting all the regulatory procedures can be quite complex. So for this you could hire the best professionals to handle this on your behalf. Also, remember that you have to send this data to the FDA (Food and Drug Administration), or the equivalent in your country, for approval before starting researching and testing or starting any 4 phases of trials.
Recruitment of Patient and related professionals is key in determining trials success
This step involves the identification and engagement of the different stakeholders, from sponsors, investigators and patients. It’s important that you keep constant open communication from the start. Also, consider each stakeholders representation and input from related committees.
Hold the end goal in mind when planning the 4 phases of your trial
In Phase I start by assessing the safety of the device/ drug. This might involve 20 to 100 healthy volunteers, with the intent of determining the effects of your drug like how it’s metabolized, absorbed, and excreted, or possible side effects occurring as you increase dosage levels.
The second Phase tests the drug efficacy. Most studies here are randomized trials. It’s best if the studies are “blinded” as that lets investigators provide comparable data for the pharma company as well as the FDA about the effectiveness and relative safety of this new drug.
In Phase III randomized and blind testing provides more data on the drug’s effectiveness, it’s benefits and the scope of possible unpleasant reactions. Of importance, after this phase is completed, the pharma can request FDA’s approval to market the drug.
In Phase IV/Post Marketing Surveillance Trials will compare the drug with other drugs available on the market. Here’, you need to monitor the drug’s long-term efficacy and impact on patients’ quality of life. Then you can determine the drug’s cost-effectiveness relative to new and other traditional therapies.
Create an adequate resources and budget plan
Develop milestones and ways to track your cost. Use the best methods to measure the drug’s performance. Remember, measuring allows you to improve it.
Run SWOTs analysis on your design
Run a SWOT analysis (strengths, weaknesses, opportunities, threats) analysis which includes policy, competition, seasonal fluctuations, rarity, awareness, and disease stage, plus satisfaction with the existing therapies, and any economic concerns. Predict any unwanted events to help you identify potential drawbacks and bottlenecks. Consider using historic or bench-marked data to come up with realistic timelines.
A successful clinical trial should be designed with the main aim, timeline, and milestones in mind. Be sure to work with a group of knowledgeable and diverse people, and provide a safe and open environment where feedback and ideas are welcome. Such an environment will help you speed up and develop the process to deliver your drug on the market to help change the world.
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