An official agreement is signed between the investigator and company and s/he may receive milestone payments. The investigator www.selleckchem.com/products/Erlotinib-Hydrochloride.html is expected to take the study all the way to publication (the researcher is not mandated to share the manuscript with the company) and update CTRI accordingly. In such studies there is no indemnification of the investigator or insurance of the patient by the company. The company only funds the investigator. All other liability rests with the investigator as outlined in the agreement. The investigator is expected to follow the law of the land (e.g., inclusion of the compensation clause in the informed consent form). In case a patent or data exclusivity may arise out of data generated from the study, the investigator has the right to decide whether s/he wishes to share the same with the company.
Some companies have an agreement with the investigator on co-sharing of patent holder rights. Similarly, the data may be submitted to the regulator in support of a new indication for a product. In such cases it is a different agreement (as with the patent case) and now the company does share liability and may decide to monitor such a study. Such IITs do serve to add to the body of generalizable evidence and advance medical science. It need not have anything to do with the company or its products or therapeutic area. Of course IITs can also be funded by non-industry, academic bodies or the government. There is always skepticism if industry funds any research though even in industry-sponsored studies, ultimately it is the investigators?? study as the data is of their patients, they have full access to the raw data, they review and approve the study report and publication.
So whose study is it anyway? One example of a large IIT is the Anglo Scandinavian Cardiac Outcomes Trial (ASCOT). A good idea would be to simply fund an academic body Anacetrapib such as the European Association for Study in Diabetes (EASD) which writes and updates guidelines. If one reads guidelines one does come across areas where research is needed to answer hypotheses. Such research can be funded by industry although it may have nothing to do with their products. Thus one has more of evidence-based medicine and less of opinion- or eminence-based medicine. Industry (I) could come together with Academia (A) and set up an Institute of Real World Research (R) which can fund such IITs thus also clearing the AIR of misperceptions and increasing transparency.
Competitors could collaborate with each other and facilitate practical or pragmatic clinical trials and comparative effectiveness research. selleck compound It is not that one drug is better than another. The real issue is no longer the choice of the ??best?? agent, but rather the identification, on a rational basis, of the population of patients who will benefit from a given agent the most.[2] In practice when a doctor sees every patient s/he is in effect doing a clinical trial.