There are three main factors to consider when conducting clinical trials on natural health products. The first is to ensure that the company you are working with respects the natural health product regulations. The second is to ensure that the trial is conducted in a manner that is as ethical as possible. The third is to make sure that the trials are conducted in accordance with the Food and Drugs Act (FDA).
Reduce the burden associated with the 25-year records retention period for clinical trials
If you're a pharmaceutical or biotech company, you're probably familiar with Health Canada's latest update to its clinical trial regulations. The changes, which are being rolled out on a quarterly basis, have the potential to reduce the burden associated with obtaining and maintaining industry-sponsored clinical trial data. The new rules also apply to all new trials authorized after publication. For sponsors looking for the best way to save money, there are several steps to take.
Specifically, you should consider the aforementioned changes as an opportunity to revamp your retention policies, update your clinical trials' memorandum of knowledge and improve your data sharing protocol. It's also a good time to review your clinical trials' past and present data and compare and contrast the results against your peers. The benefits of such a data-sharing collaboration are well documented. A single point of entry and a single data repository will allow sponsors to centralize their most sensitive information into a secure, single source of truth. In addition, a single database allows for better, more efficient data management.
The bottom line is that reducing the time and cost required to collect data will enable sponsors to focus on what really matters. That is, developing new products and improving the efficacy of existing ones. The new regulatory regime, in particular, will likely have a major impact on the productivity of the drug and biotech industry. As such, it's a win-win for patients, researchers and clinicians alike. As the industry moves forward, it's likely that new drugs will be developed faster and safer. This is especially true of pharmacokinetic and pharmacodynamic studies, where the data is gathered from multiple patient populations.
Exemption from section 3.1 of the Food and Drugs Act (FDA) for clinical trials
In the Fall Economic Statement for 2018, the Government of Canada announced that it would be exempting natural health products clinical trials from section 3.1 of the Food and Drug Act (FDA). As a technical measure, this exemption will continue until May 23, 2020, and will be subject to amendment. In addition, it will remain in effect until the proposed Modernization of the Regulation of Clinical Trials initiative is implemented. The purpose of the exemption is to provide stability for sponsors of clinical trials, as well as for investigators. It also supports the submission of new drugs to Canada, and ensures that patient safety is maintained at an appropriate level.
The Government's proposal is included in the Global Systems theme. It is designed to support the competitiveness of the Canadian clinical trial industry internationally. It is anticipated that the cost to organizations will be about $500 per trial. It is also expected that the costs of the terms and conditions will be approximately $100 per trial.
In addition, reducing the records retention period will benefit the Canadian clinical trial industry as a whole, and support increased access to novel therapies. It is also expected that the reduction in record retention will help maintain an appropriate level of patient safety oversight. The Siho Effect
The current FDA framework is based on the MDR or FDR authorization pathways. This framework has a 25-year records retention requirement for clinical trials. The Government of Canada's proposal was intended to lessen the burden associated with this long-term records retention requirement. It is expected that the reduction in records retention will reduce the amount of regulatory paperwork and administrative burden for sponsors and investigators.
In addition, the reduction will help to improve the competitiveness of the Canadian clinical trial industry as a whole. As a result, stakeholders recognize that the savings could be significant. However, the exact savings will depend on the part of the trial, the number of participants, and the complexity of the trial. The reduction is expected to be a positive step in the Canadian government's commitment to simplifying the federal regulations.
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