Commercial Strategy & Clinical Development Plan, Essay Example

Assignment Review

Protocol Elements

Protocols need to be created in order to protect study subjects, describe the methods used for concluding the study and meet compliance and regulatory requirements. Further, the different elements that need to be present in order to clearly determine the methods and purposes:

1. objective
2. phase
3. design
4. methodology
5. statistical considerations
6. study organization

Protocol standards are also needed to ensure the credibility of data and rights of the public are protected. The ethical issues also need to be addressed in a way that the study complies with Good Clinical Practice, regulations and the Declaration of Helsinki.

An informed consent declaration needs to be signed by all participants, covering their understanding, awareness and suitability. External checks also need to be implemented in the study protocol in order to check the reliability of data and the compliance with procedures. Non-compliance and inaccuracy of data can have ethical, cost (extra hours), analytical and reputation-damaging consequences.

Data handling applications and software-based analysis need to be tested prior to the trials, in order to facilitate monitoring, ensure reliability of the system and standardize conduct, as well as analysis. This task usually belongs to the evaluation manager, who, after sufficient checks are completed, creates a system validation report. This ensures that the data collected is accurate, complete, verifiable, consistent and can be handled in a timely manner. The implementation of standardized data collection can also increase data quality.

Commercial Strategies

Commercial strategies are designed to create profit for the companies. However, they need to be planned in a way that they minimize risks for patients, the investors, while keeping costs at the lowest possible level. Planning is important, as it can speed up the process of getting safe medication out for patients, as they would take less time to get approved. Study designs need to be focused on the end goal and be efficient through collaboration between registration, research, marketing and regulators. One of the tools for commercial strategies indicating the goals and proposed outcomes is Investigator’s Brochure, which highlights the purpose, the effects and guidelines.

Safety Issues

Safety issues have a great impact on participants during the trial, at site and future drug and treatment recipients. When risks are not assessed carefully and eliminated during the design and implementation, extra costs can occur, as modifications need to be completed or the trial needs to be stopped. An adverse event can also damage the reputation of the sponsor and endanger participants, affecting their rights. One example of adverse effects is adverse drug reaction, which can be avoided during the planning phase of the study protocol, during careful selection of participants and evaluation of the drug. The risks of adverse effects need to be clearly communicated with participants, while sponsors need to complete ongoing safety evaluation. Investigators also need to closely monitor the procedures and study, according to the regulatory requirements. It is also the responsibility of the investigator and the Data Safety Monitoring Board to report any safety information and risks.

Future Goals

Accelerating pharmaceutical research while reducing costs is the challenge of the future. By creating transparent and suitable designs, eliminating risks, companies are able to reduce research budgets, create more reliable solutions faster, while maximizing their profitability. Effective patient recruitment strategies include effective communication, promotion through outreach programs. Increasing measures to protect study subjects can also have an impact on the rate of final participation numbers. FDA, Federal regulations and individual circumstances also need to be considered when designing study protocols.