Increasing clinical trials reliability

The new clinical trial regulation (EU Regulation No. 536/2014), created in April 2014 is in full evaluation to the end of May 2016. Its goal is to harmonize the procedures for clinical trials across the EU while making sure of the safety of clinical trial volunteers, the ethicality of trials and the dependability and productive effect of data derived. It advocates increasing reliability with regard to clinical trials results, data and their result.

Indeed, full access to internet, mobile devices and the availability of social media have gaped in a wide range desire for access to clinical trial awareness and result from researchers, patients and consumers alike. For life science companies, clinical trial information is highly of discreet affair which permeates a wide cultural evolution given that they operate in a very systematic and competitive environment, with lots of risk and profit.

Safety first 

The new rules here strives to take off the EU Clinical Trial Directive 2001/20/EC, which the European Commission apprehended enabled an important decrease in the number of clinical trials conducted across Europe, and increased the administrative accumulated load and the time lapsed to enforce new trials by 90 per cent. The new EU regulation becomes applicable all through the EU member states; it provides a level of regularity that has been crippled over the past decade. The goal here is to design a friendly environment for practicing clinical trials, while the highest standards of patient safety, across the EU is highly considered. The current rules are simplified categorically here:

•  Highlighting the process for evaluating and justifying meaningful clinical trials, extracting duplicability of data and taking off staggeringly slow method in launching new clinical studies.
• Implementing a lighter regulatory system for trials given with medicines that are already authorised and which may only have minimal risk in comparing to normal clinical practice.
• Making the report requirements simplified, sparing researchers from submitting duplicated data on the procedure of the study to various forms.
• Understanding that a trial can be implementated implemented by more than one organisation, by formally introducing the idea of co-sponsorship. Both researchers and patients should be provided with ideas of past trials and their results, and any endless repetition of same studies by establishing clinical trial outcome, whether good or bad, developing transparency.

Going to the open

The last few years, apprehended increasingly noticeable numbers of life science organizations which have adopted a more free and transparent policy with regards to the results of their clinical trials, regardless of the positive or negative results. This is a more spaced out policy which advocates good leadership and important investment from finance and human resources by the provision of stronger analysis, smooth knowledge of treatment results and help in identifying other uses for products.

Clinical trials are an important part of the provision of new medicines and also have a part in the development of medical care more densely. The conventional guidelines for designing a drug is made up of five key study phases: preclinical, clinical trial phases I, II and III, and post-marketing phase IV. At the first three clinical trial phases, where the study subject is more likely at risk, implementation of clinical trial data outcome enables in reduced risks and avoidance of identical or duality of efforts by other companies trying to establish the same kind of studies. This could then open up research resources to be delegated to other clinical trials. More so, the results of these publications will in time help physicians to better match products and essentially, the new structure will bring about procedures for sponsors to submit a public available summary of the results of the trial within one year of its end, regardless of the result (positive or negative). Moreover, for clinical trials which have led to a request for marketing approval, a full clinical study report will be submitted for publication in the EU database.

In order to subvert the mean commercial use of the data, the European Medicines Agency has defined a systematic way for publication of clinical reports with reports on-screen for any user, with a simple registration process, and other downloadable clinical reports at the expense of its identified users. Both situations will be guided by strict terms of use. This action will bring awareness to researchers, patients and the public to be aware of both the trials of the past and their outcomes. When stated in for general informational reasons, the users can may know the results but may not download or save them. And also users logged in for academic and non-commercial research purposes may download clinical study reports, transcript, and copy data.

A moral duty

A 2014 research survey by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, stumbled over breath taking, that majority of doctors gave full support to the principle of “Clinical Trial Data Transparency” and that such information should be free and easily accessible. 81 per cent of respondents talked to agreed that a “moral duty” should exit for drug manufacturers to submit the finished available data to trial participants, the general public and the research community, and 87 per cent agreed that strict procedures and screening of data will lead to better science and research.

There are many guidelines that pharma companies will have to rethink when planning to make their clinical trial data publicly available. These guidelines are:

• Establishing a Clinical Trial Disclosure Governance Committee. 
• Devising an open structure and guideline for the company. 
• Enforcing a procedure for handling clinical trial result requests. 
• Inhabiting a technology for redaction, especially to protect study subjects’ private information and commercially sensitive information. 
• Bringing up a structural process for embarking a study summary and clinical study report. 
• Selection of an IT solution for publication and submission of data to regulatory authorities. 
• Allocation of available resources to guide the clinical trial transparency landscape including regulatory requirements and industry trends.

The major benefit that will be encountered from the growing need for clinical trial transparency and disclosure is that patients at this point will be able to gain from reasonably good prescribed products with higher quality of life. Disclosing clinical trials results by life science companies will make use of resources rationally and avoid duplication of studies. Whole hardheartedly, the accessible information is the better possible innovations.