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Q of the week

Q: Define Individual Case Safety Reports??

Get the Answer: 

Confirmatory trials
The purpose of these trials is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. These trials may be carried out by clinicians in the concerned therapeutic areas, having facilities appropriate to the protocol. If the drug is already approved/marketed in other countries, phase III data should generally be obtained on at least 100 patients distributed over 3-4 centres primarily to confirm the efficacy and safety of the drug, in Indian patients when used as recommended in the product monograph for the claims made.
Welcome to GCP HelpDesk Website 

In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations.  This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Research with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk   and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback  page and we appreciate your suggestion and comments.

Clinical Research Today

FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid

On 08 Oct 2015, the U.S. Food and Drug Administration allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections.  

The FilmArray Meningitis/Encephalitis (ME) Panel uses CSF specimens from patients who have ...


FDA approves Keytruda for advanced non-small cell lung cancer

On 02 Oct 2015, the U.S. Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. ...


FDA approves two new drug treatments for diabetes mellitus

the U.S. Food and Drug Administration approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

According to the Centers for Disease Control and PreventionREAD MORE

FDA approves new drug to treat schizophrenia and bipolar disorder

On 17 Sep 2015,the U.S. Food and Drug Administration approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” said Mitchell Mathis, M.D., director of ...


Call to action to improve the health of women, children and adolescents worldwide

On 14 September 2015: GENEVA In a special supplement published by The BMJ, public health experts from around the globe highlight the critical actions and investments that will have the greatest impact on the health of women, children and adolescents. Although great ...


EMA’s medical literature monitoring enters into full operation

Extended service will improve safety monitoring of medicines and simplify pharmacovigilance activities for companies

The European Medicines Agency (EMA) starts its full medical literature monitoring service on 1 September 2015.

A total of 400 active substance groups (300 ...


Consultation on new ICH guidance document on good clinical practice.

The European Medicines Agency (EMA) is consulting on a new International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document on good clinical practice (GCP). The aim of the guidance is to provide a unified ...


FDA extends use of Promacta in young children with rare blood disorder

The U.S. Food and Drug Administration approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these ...


FDA takes action against three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling

The U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as ...


Updated guidance on good clinical practice released for consultation

Comments on the ICH E6 addendum are invited until 3 February 2016.The European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2)READ MORE

FDA approves first treatment for sexual desire disorder

On 18 Aug 2015, the U.S. Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.



Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.