Posts by Dan Sfera

How Is Your Private Data Kept Confidential When You Join A Clinical Trial?

Nov 05, 2012 Leave a Comment ~ Written by Dan Sfera

I got asked a fantastic question from a trial participant out there today who was worried that his clinical trial data would be sold and used without his consent. I decided to do this video and provide what I know regarding this.

The fear of someone getting a hold of your personal information is understandable. In this day and age, identity theft is on the rise, and it makes sense to be extra vigilant in regards to your personal information. Many people have this fear when it comes to clinical trials. It is important to understand that laws and regulations exist to protect your personal information when you participate in clinical trials. The only people who have direct access to your personal health info when in a study are the individuals immediately involved with your care at the research clinic. Thats it. No one else. No drug companies, no marketers, no insurance companies, nada. Study centers are responsible for de-identifying all personal info from an individual in the trial. Therefore, when pharmaceutical companies go to review the data, they don’t see your name and social security number, but they see a unique study identifying number to identify you and all the data from the study associated with you. Therefore, you can rest assured that you will not be getting junk mail or spam from anyone because of your participation in a clinical trial. Furthermore, your insurance company has no way of knowing that you participated in a clinical trial either. (Some exceptions with insurance companies do exist with cancer trials so ask your study doctor about that first).

Posted in Featured, Study Participants - Tagged confidential, data, hipaa, informed consent, privacy

Advantages and Disadvantages Of Conducting Clinical Trials in India

Nov 04, 2012 Leave a Comment ~ Written by Dan Sfera

The topic of clinical trials and India has been making headlines lately. I recently did a very good interview with Drashan Kulkarni regarding the Indian Supreme Court and it’s actions against some clinical trial companies here. Another interview with Darshan regarding the Indian government considering FREE drugs for all can be found here. This blog post will basically highlight some of the advantages and disadvantages of conducting clinical research in India.

The first set of ethics rules for research in human formulated by the international medical community was established in 1964 by the WORLD MEDICAL ASSOCIATION (WMA) in the Declaration of Helsinki (Declaration). The WMA is an international organization representing physicians and was founded in 1947. The organization was created to ensure the independence of physicians and to work for the highest possible standards of ethical behavior and care among them, at all times.

India is making a name for itself in the international pharmaceutical arena as a preferred destination for leading pharmaceutical companies to conduct clinical trials and it is challenge for both the government and the private sector, to create a balance between ethics and trade. The Indian government has played its part by standardizing the regulations governing the conduct of clinical trials and the private sector, which includes pharmaceutical companies and contract research organizations, has succeeded in conducting global clinical trials in India.

An increased awareness of good clinical practice requirements and stronger desire for international acceptability of research carried out in India have brought favorable changes in the attitudes of Indian clinicians towards participation in clinical trials. Investigators are eager to take part in clinical trials and execute the protocols of US, Japanese and European drugmakers.

According to a joint study by international consultancy Ernst and Young, and the Federation of Indian chambers of commerce and industry, India now participates in over 7% of all global phase 3 and 3.2% of all global phase 2 trials. Furthermore, a report by another market research firm says that the clinical trial outsourcing market in India is forecasted to grow at a compounded annual growth rate of over 30% during 2010-2012 to around and 600 million by 2012. In this context, the changing regulatory framework for clinical trials in India as well as the advantages and challenges of carrying out trials in this market will be examined further.

In India, the central government, via the central drugs standard control organization under the ministry of Health and family welfare, largely works in developing standard and regulatory measures for drugs, diagnostics and devices, laying down regulatory measures by amending acts and rules, and regulating the market authorization of new drugs– all in effort to standardize clinical research in India and bring safer drugs to the market.

Apart from specific elements of the Indian market that attract global players; the main aspect that has put the country at an advantage is the notable momentum adopted by the Indian Council of Medical Research and CDSCO in tandem with global regulatory guidelines . One must keep in mind that India’s involvement in global GCP (Good Clinical Practice) has only existed since the past decade.

With the number of clinical trials being conducted in India increasing rapidly, the regulatory bodies recognized the need to frame guidelines and regulatory approval processes in order to be on par with international standards. The DTAD, for example ,endorsed the adoption of GCP guidelines for streaming clinical studies, which have been incorporated into governing clinical trials. The CDSCO has made the guidelines available to the public on its websites in order to ensure a level playing field.

Some of the main advantages of carrying out clinical trials in India are:
-Strong availability of study subjects across major therapeutic segments.
-High level of ICH GCP AND US food and drug administration standards compliance (since 2001, The DCGI has implemented conformity to ICH, GCP and good laboratory practice guidelines. Generally, most competent authorities, including the US FDA, will find the standards of Indian clinical trials acceptable).
-High quality of research professionals (India has a strong reputation for graduating students in the medical and scientific fields. The government is involved in curriculum development at major universities and students pursuing these fields of study are given financial incentives to study in India).
-A favorable regulatory environment that allows the conduct of global trials, duty-free imports of drugs intended for use in trials bioequivalence studies for export of data.
-Cost competitiveness (depending on the number of patients and investigators, and the advantage over a similar trial in Europe or the US).
-Increasing prevalence of diseases.

Approval of clinical trial documents from both the IRB (Institutional Review Board or ethics committee)/or IEC and DCGI is mandatory to initiate a study. Because India’s potential as a major hub for global clinical research has been acknowledged, the regulatory bodies have to elevate themselves to meet international standards, and they are facing some challenges. Some of the major issues that have been recognized as areas in need of improvement are explained below.

Lengthy Approval Timelines
International phase 1 clinical trials with new chemical entities developed in a foreign country (First –in-human trials) are not allowed in India. Moreover, clinical trial applications submitted to the DCGI where the DCGI office does not have the competency to review such protocols are sometimes referred to outside agencies such as the ICMR, the BARC, the DBT, the AERB and /or the GEAC for their review and expert opinion. This process results in larger review times. When this occurs, the additional time involved is unpredictable. Occasionally, these referred bodies do not have the competency to review the submitted protocol, therefore expert committees are constituted to review the protocol and other submitted documents. Ample time is taken to constitute such committees. This committee must then overcome some other hurdles such as the fact that expert committee members must be available to meet at a joint forum. The decision is usually not taken during a single session, therefore multiple sessions are required. Furthermore, queries raised during such meetings take a significant amount of time to be drafted and circulated to the applicant’s response. Finally, the committee has to meet again to review the documents submitted to make the final decision. As one can clearly see, the approval timelines for these trials is no walk in the park, even in India.

Posted in Featured, Research Professionals, Study Participants - Tagged ethics, gcp, India, overseas, Regulatory, research professionals

Catch My Exclusive Interview With Christine Pierre, Founder Of The First Ever Clinical Research Site Trade Association

Nov 02, 2012 Leave a Comment ~ Written by Dan Sfera

As a follow up interview to my blog post a few weeks ago regarding the Society for Clinical Research Sites (SCRS), which is the first ever global trade association for research sites established, I sat down with SCRS founder Christine Pierre and got into some more details with regards to the SCRS and how it will function. In this interview I learned a bit more about the SCRS. For example, the SCRS is not limited to just US research clinics, or simply only research clinics at all. It is open to any global pharmaceutical, CRO’s, or research centers that exist. There are membership dues and sites have the option of entering data about themselves such as past study performance, audit history, study participant demographics, etc. Mrs Pierre did inform me that they are currently using an honor system where the data that is entered will not be fact checked. This answered some of my questions, and I also got a nice glimpse into the site selection process that, according to Mrs Pierre, is not the main focus of the SCRS as I initially thought. Catch all of this and more in this exclusive interview and as always, stay tuned for more information on the SCRS as it develops.

Posted in Featured, Interviews, Research Professionals - Tagged business development, cro's, overseas, research clinics, sponsors, trade organization

How Do Small, Niche CRO’s Survive? By Forming Strategic Alliances With Each Other Of Course!

Nov 01, 2012 Leave a Comment ~ Written by Dan Sfera

In a direct response to some of the larger CRO (contract research organization) consolidation over the past five years, market share for CRO’s has been dominated by several large, key players such as Quintiles, PPD, Parexel, INC Research and the usual suspects. What we are beginning to see besides some of the smaller niche CRO’s either getting acquired or closing their doors, some are looking to form strategic alliances with each other in order to thrive in this environment. One of the companies, Vince & Associates, which I reported on a few weeks ago here, is one of six specialty CRO’s that have formed an alliance with each other called next IND. According to next IND’s official statement, “next IND is a strategic alliance of niche CROs, each filling a key step in the drug development process and combining to create a comprehensive suite of services to take a drug from concept to IND.” The official statement continues, “next IND is comprised of six CROs – all widely considered experts in their respective areas. In the non-clinical space Cedarburg Hauser offers substance process development and manufacturing services, XenoTech offers in vitro drug metabolism services, Formurex offers preformulation and formulation services as well as GMP manufacturing, Xenometrics offers toxicology services, and KCAS offers bioanalytical services. Clinical research services are provided by Vince & Associates.” Whether alliances such as this become a trend in the clinical research space, it is clear that the smaller CRO’s are looking for where they can fit in when it comes to the overall CRO marketshare. Under this scenario, a smaller Pharma company that may not be able to afford the services of a larger CRO, would turn to an alliance such as next IND and be able to save time and money due to the streamlined approach that the alliance provides. As always, stay tuned for a possible interview I am trying to set up with one of these companies, or a representative from the alliance itself.

Posted in Featured, Research Professionals - Tagged alliance, business development, cro, pharmaceutical

At-Home Clinical Trials May Be Increasing In Popularity

Oct 31, 2012 Leave a Comment ~ Written by Dan Sfera

A few blog posts ago I discussed Pfizer’s recent Virtual Clinical Trial, a trial in which most of the study procedures for the overactive bladder study were conducted in the homes of the study participants. While the study struggled due to enrollment issues, it may prove to be a paradigm shift in the clinical trial model. I plan on re-interviewing Craig Lipset, one of Pfizer’s Directors and innovators behind this virtual clinical trial. You can catch my popular part one interview with him here.
Despite the failure of this particular trial due to poor recruitment results, virtual or at-home clinical trials have been gaining in popularity and may prove to be a worthwhile endeavor for research clinics to pursue. In this recent article on Applied Clinical Trials, the author discusses the fact that many trials have migrated outside of the United States both due to cost-saving measures, as well as in hopes of finding a new consumer market to sell the drugs to once clinical trials are completed. Since the infrastructure in these countries often mean a spread out population with few research centers in between, the in-home clinical trial model can prove to be effective in these situations. Another argument for investing further in these virtual clinical trials is the fact that retention rates and drop-out rates have been relatively high as of late under the traditional clinical trial model in which the study participant is asked to go the research clinic approximately one time a week for several hours at a time. This model may be difficult to retain study participants in as the inconvenience of missing work, driving long distances to the clinic and blocking out a significant portion of their busy schedules to attend a study visit may eventually cause the study participants to either miss appointments, drop put of studies altogether, and perhaps have compliance issues maintaining their study treatment. The at-home clinical trial model can hypothetically change this as these study procedures can be conducted in the comfort of the study participants’ home wat a time that would be convenient to them. Many procedures such as blood draws, ECG’s, patient questionnaires, etc can be conducted in-house rather than in a clinic. Sounds like a good idea? Yes. However, as with anything as complex as clinical trials, there are always drawbacks. One of the biggest costs of clinical trials are studies dragging on longer than anticipated due to recruitment issues. The Virtual Clinical Trial’s shortcomings may prove to be recruitment. There is a certain element of recruitment in clinical trials that entails trust, and so far, call centers and online portals do not communicate a certain level of trust for would-be study participants to respond to in numbers that drug sponsors would like to see. I did an interview on this topic a while ago where we discussed traditional recruitment methods and how they are still far superior to new-school methods mostly because of trust. Another key component of recruitment is the study participant’s physician himself/herself. If at-home clinical trials can start after a communication has been established between physician and participant, they would have a chance to suceed. If not, we’d just get more of the same result.

Posted in Featured, Research Professionals, Study Participants - Tagged overseas, recruitment, social media, virtual clinical trials

New Study Reveals Black Patients Offered Clinical Trials Less Often Than Whites

Oct 30, 2012 Leave a Comment ~ Written by Dan Sfera

In a presentation at the Science of Cancer Health Disparities Conference these past few days, researchers highlighted results from a recent study which videotaped the way oncologists discuss clinical trial options with their patients. In this particular study, 22 video recordings in which a clinical trial was offered were analyzed of oncologists discussing clinical trials with their patients, 11 of whom were white and 11 of whom were black. Not surprisingly, as studies were done on this in the past (however this is the first study that utilizes real time data), African Americans were spoken to overall less than their white counterparts. African Americans were also offered clinical trials less than Whites in this analysis. Informed Consent of the study was also explained less to blacks than whites. The study also shows, and previous studies confirmed, that black patients also ask their physicians fewer questions and overall speak less than the white patients which were analyzed.
One of the researchers, Susan Eggly, PhD, commented, “Minority patients tend to receive less information, which could, in part, explain under-enrollment by minorities in clinical cancer trials, these disparities could also lead to minority patients being enrolled in trials without fully understanding the purpose of the trial and the potential risks of participation.”
The reason for the lack of minority, specifically African American, participation in clinical trials has been looked at and discussed before. In fact, I did an interview here with someone from John Hopkins University on the reason African American lack trust when it comes to clinical trials. The key seems to stem from an adequate lack of communication between physician (usually white) and minority patients. Whether this can be changed by better educating physicians on how to include minorities into these conversations, or simply encouraging more minority youth to pursue a career in medicine, the current result is that there is an obvious problem here that needs to be repaired. For more information on the study I am writing about, please check it out here. As always, let me know your thoughts.

Posted in Interviews, Research Professionals, Study Participants - Tagged african americans, cancer, ethics, informed consent, minorities, oncology, recruitment