Jan 21, Dec 13, Recommended for you. Research team finds new dual benefit mode of action for a drug candidate to fight COVID 1 hour ago. Load comments 0. Let us know if there is a problem with our content. Your message to the editors. Your email only if you want to be contacted back.
Send Feedback. Thank you for taking time to provide your feedback to the editors. E-mail the story New trial demonstrates improvements in immunosuppressive treatment of patients with severe aplastic anemia. Your friend's email. Your email. I would like to subscribe to Science X Newsletter. Learn more.
Your name. Note Your email address is used only to let the recipient know who sent the email. Your message. Your Privacy This site uses cookies to assist with navigation, analyse your use of our services, collect data for ads personalisation and provide content from third parties.
I'm OK with that Cookie options. E-mail newsletter. It appears that you are currently using Ad Blocking software. Evaluation of cost-effectiveness of two or more treatment options endovascular strategy versus open repair for the management of a ruptured abdominal aortic aneurysm. The benefits of IIS are summarized in Table 1. Many clinicians who take part in pharmaceutical industry-sponsored trials often express their dissatisfaction as they are not involved in designing of the study or analysis, interpretation, and ownership of the data.
They merely implement these studies. IIS offer clinicians an opportunity to do all of the above. However, initiating, sustaining, and taking an IISs to fruition is not an easy task. Challenges range from finances, regulatory submissions, continuous oversight, training of study personnel, lack of expertise in statistics, data management, and medical writing.
A PubMed search of their own published studies. One interventional study with a high degree of risk was the pharmacokinetics and safety of intravenous colistin in patients critically ill with multi-drug resistant Gram-negative infections.
After this, the IEC approved this study. An IIS of a similar nature was, however, disallowed by another IEC based on the argument that the funder should compensate for research-related injury including deaths that can occur in critically ill patients. They wanted their funding support to be restricted only to provision of drugs for the study.
We see at least three prominent challenges that exist with IISs that are interventional in nature and involve a fair bit of risk. The first is that the average investigator will not have the necessary funding and the required expertise in the myriad trial areas ranging from conceiving of the research question to biostatistics and data management , for example to take the study through to fruition and may have to involve the pharmaceutical industry. Their involvement is more often than not likely to be construed by the IEC as a backdoor entry for the study for the benefit of the pharmaceutical industry to be done under the guise of an IIS.
This is very difficult to prove or disprove and can lead to important studies not being done. Second, the current guideline of the Indian Council of Medical Research ICMR, on Biomedical and Health Research involving human participants[ 14 ] mandates that compensation should be given for research-related harm including death and the budget for the study should make provisions for this.
Unless institutions in the country create a corpus for provision of compensation, studies with more than minimal risk simply will not be done.
For many institutes in the country including medical colleges, patient care still remains the priority area followed by education and research largely takes a back seat. Until this is addressed, much of the IISs in the country will largely remain observational.
In the absence of a reply, the IEC would give its nod for the study. While this is an extremely important step toward promoting IISs in the country, it needs to be strengthened by sufficient training of IECs who need to gain experience and expertise in benefit-risk assessment so that the patients who consent to participate in such studies are protected at all times.
In addition, these studies also require the requisite funding to pay for research-related injury, an aspect alluded to earlier. Even though IISs pose many challenges to researchers, most of them can be overcome with robust internal policies and adherence to regulatory requirements. All the challenges discussed earlier should not act as barriers for IISs but rather as useful learning tools for researchers to improve their quality of research.
The authors propose a few solutions based on their past experiences after being associated with multiple IISs over the years. These solutions are outlined in Table 3. One way to strengthen and help IISs grow in the country is to establish Clinical Trials Units or Clinical Research Units in academic centers that would help investigators take studies to fruition. Clinical trials proposed upon the initiative of clinical Sponsor-Investigators and without the company taking the role as a sponsor are termed Investigator Initiated Trials.
What is driving the need for IITs? Clinical trials are not, and cannot be, designed to determine all the potential uses for a medication.
IITs expand product knowledge, including safety. Physician researchers often identify new ways of using existing treatments, thus improving the health of numerous other patients. And there is always greater weight attached to non-industry sources of data. Even large pivotal randomized clinical trials are done by academic research organizations, e.
On the face of it we must have more investigator initiated trials. The usual practice is to design global clinical development programs with the help of researcher-clinicians and then place studies in countries where carefully selected investigators execute the study under the oversight of clinical operations.
The principal investigator is sometimes reduced to being a pure implementer. At least those clinicians who participate in protocol development meetings get the satisfaction of being a part of cutting edge research and not merely being the executors. But the evidence from such gold standard prospective, randomized, double blind, controlled clinical trials, while it may help prove the efficacy of the drug and garner marketing authorization approval, may need to be complemented by studies done by doctors in the real world.
The former is limited in extrapolation or generalizability and therefore the other RCT or the Real world Clinical Trial needs to be initiated. Of course, IITs can also be done pre-marketing, e. While companies do conduct such phase IV studies, it is also good if investigators initiate their own research in the post-marketing environment. Some IITs are in scope and some are not in scope from the company's perspective. Whether data from IITs, funded by a company, can be used for regulatory submissions to get new indications approved is a matter of debate since these studies are generally not monitored by the company per its SOPs.
There are some important caveats. The trial request must be initiated by the investigator and not by the company. It has to be a spontaneous, unsolicited request. The same needs to be directed to the medical department. Whether the company will benefit from the study or whether it involves the product or therapeutic area or whether the investigator is important to the company should not be criteria for approval.
Scientific rationale, study design, endpoints, formulation, statistics, budget and availability of local human and financial resources as applicable to oversee and support the study should be the criteria for approval, and compliance with ICH-GCP or local GCP regulations and all laws, rules, guidelines and regulations applicable to the planned IIT, including local, anti-corruption, anti-bribery and anti-kickback laws.
Hence expectations need to be managed upfront. If yes, then a protocol template may be sent to the investigator who is then expected to flesh out the concept note into a full-fledged protocol.
0コメント